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Trial record 99 of 668 for:    CARBON DIOXIDE AND arterial

Cerebral Blood Flow During Propofol Anaesthesia

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ClinicalTrials.gov Identifier: NCT02951273
Recruitment Status : Completed
First Posted : November 1, 2016
Results First Posted : November 17, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Niels Damkjær Olesen, Rigshospitalet, Denmark

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Gastrointestinal Neoplasms
Intervention Other: Study of cerebral blood flow
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study of Cerebral Blood Flow
Hide Arm/Group Description

Patients undergoing oesophageal- or ventricular resection (n=30)

Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Period Title: Overall Study
Started 30
Completed 27
Not Completed 3
Arm/Group Title Study of Cerebral Blood Flow
Hide Arm/Group Description

Patients undergoing oesophageal- or ventricular resection (n=30)

Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  33.3%
>=65 years
18
  66.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
65  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
13
  48.1%
Male
14
  51.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
27
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Denmark Number Analyzed 27 participants
27
 100.0%
Internal carotid artery blood flow during anesthesia-induced hypotension  
Mean (Standard Deviation)
Unit of measure:  Ml/min
Number Analyzed 27 participants
193  (41)
1.Primary Outcome
Title Changes in Internal Carotid Artery Blood Flow by Treatment of Anaesthesia-induced Hypotension
Hide Description Unilateral internal carotid artery blood flow [ml/min] assessed by duplex ultrasound.
Time Frame Two measurements; one measurement during anaesthesia-induced hypotension (mean arterial pressure < 65 mmHg) before administration of phenylephrine and one measurement 3-5 min after administration of phenylephrine.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study of Cerebral Blood Flow
Hide Arm/Group Description:

Patients undergoing oesophageal- or ventricular resection (n=30)

Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Overall Number of Participants Analyzed 24
Mean (95% Confidence Interval)
Unit of Measure: ml/min
27
(3 to 51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study of Cerebral Blood Flow
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0276
Comments [Not Specified]
Method repeated measure mixed model
Comments [Not Specified]
2.Secondary Outcome
Title Changes in Internal Carotid Artery Blood Flow by Induction of Anaesthesia.
Hide Description Unilateral internal carotid artery blood flow [ml/min] assessed by duplex ultrasound.
Time Frame Two measurements; one measurement 5-10 min before induction of anaesthesia and one measurement 5-20 min after induction of anaesthesia.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study of Cerebral Blood Flow
Hide Arm/Group Description:

Patients undergoing oesophageal- or ventricular resection (n=30)

Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Overall Number of Participants Analyzed 30
Mean (95% Confidence Interval)
Unit of Measure: ml/min
-144
(-168 to -121)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study of Cerebral Blood Flow
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method repeated measure mixed model
Comments [Not Specified]
3.Secondary Outcome
Title Association by Multiple Regression Between Changes in Internal Carotid Artery Blood Flow, Mean Arterial Pressure and Cardiac Output by Treatment of Anaesthesia-induced Hypotension.
Hide Description

Association by multiple regression between changes in unilateral internal carotid artery blood flow [ml/min] as outcome variable and changes in mean arterial pressure [mmHg] and cardiac output [l/min] as covariates.

Internal carotid artery blood flow [ml/min] was assessed by duplex ultrasound. Mean arterial pressure [mmHg] was recorded by a transducer connected to an arterial line. Cardiac output [l/min] was evaluated by pulse contour analysis (Modelflow) that estimates cardiac output by analysis of the arterial pressure curve taking age, gender, height and weigth into account.

Time Frame Two measurements; one measurement during anaesthesia-induced hypotension (mean arterial pressure < 65 mmHg) before administration of phenylephrine and one measurement 3-5 min after administration of phenylephrine.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study of Cerebral Blood Flow
Hide Arm/Group Description:

Patients undergoing oesophageal- or ventricular resection (n=30)

Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Overall Number of Participants Analyzed 24
Least Squares Mean (Standard Deviation)
Unit of Measure: ml/min
376  (724)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study of Cerebral Blood Flow
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6025
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
4.Secondary Outcome
Title Changes in Frontal Lobe Oxygenation by Development of Mesenteric Traction Syndrome (MTS).
Hide Description Near-infrared spectroscopy determined frontal lobe oxygenation [%] as compared between those patients who develop a MTS (defined as flushing within 60 min after the start of surgery) and those who do not. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.
Time Frame Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study of Cerebral Blood Flow
Hide Arm/Group Description:

Patients undergoing oesophageal- or ventricular resection (n=30)

Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Overall Number of Participants Analyzed 27
Mean (95% Confidence Interval)
Unit of Measure: oxygenation [%]
2
(-2 to 7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study of Cerebral Blood Flow
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3213
Comments [Not Specified]
Method repeated measure mixed model
Comments [Not Specified]
5.Secondary Outcome
Title Changes in Forehead Skin Blood Flow by Development of Mesenteric Traction Syndrome (MTS).
Hide Description Forehead skin blood flow [PU] assessed by laser Doppler flowmetry as compared between those patients who develop mesenteric traction syndrome (defined as flushing within 60 min after the start of surgery) and those who do not. Laser Doppler flowmetry applies a laser placed on the forehead that penetrates the skin and is scattered with a Doppler shift by the red blood cells and return to a detector that evaluates the amount of backscattered light and Doppler shift. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.
Time Frame Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study of Cerebral Blood Flow
Hide Arm/Group Description:

Patients undergoing oesophageal- or ventricular resection (n=30)

Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Overall Number of Participants Analyzed 27
Mean (95% Confidence Interval)
Unit of Measure: PU
126
(57 to 195)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study of Cerebral Blood Flow
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments The reported p-value was calculated
Method repeated measure mixed model
Comments [Not Specified]
6.Secondary Outcome
Title Changes in Forehead Skin Oxygenation by Development of Mesenteric Traction Syndrome (MTS).
Hide Description Forehead skin oxygenation [%] assessed by laser Doppler flowmetry as compared between those patients who develop a MTS (defined as flushing within 60 min after the start of surgery) and those who do not. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.
Time Frame Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study of Cerebral Blood Flow
Hide Arm/Group Description:

Patients undergoing oesophageal- or ventricular resection (n=30)

Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Overall Number of Participants Analyzed 27
Mean (95% Confidence Interval)
Unit of Measure: oxygenation [%]
-2
(-9 to 5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study of Cerebral Blood Flow
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5404
Comments [Not Specified]
Method repeated measure mixed model
Comments [Not Specified]
7.Secondary Outcome
Title Changes in Internal Carotid Artery Blood Flow by Development of Mesenteric Traction Syndrome (MTS).
Hide Description Unilateral internal carotid artery blood flow [ml/min] assessed by duplex ultrasound as compared between those patients who develop a MTS (defined as flushing within 60 min after the start of surgery) and those who do not. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.
Time Frame Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study of Cerebral Blood Flow
Hide Arm/Group Description:

Patients undergoing oesophageal- or ventricular resection (n=30)

Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Overall Number of Participants Analyzed 27
Mean (95% Confidence Interval)
Unit of Measure: ml/min
-3
(-40 to 35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study of Cerebral Blood Flow
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8947
Comments [Not Specified]
Method repeated measure mixed model
Comments [Not Specified]
8.Secondary Outcome
Title Changes in the CO2 Reactivity of the Internal Carotid Artery From Before to After Induction of Anaesthesia.
Hide Description

Unilateral internal carotid artery blood flow [ml/min] assessed by duplex ultrasound and arterial CO2 tension (PaCO2) [kPa] was evaluated by gas analysis. Changes in PaCO2 are guided by evaluation of end-tidal CO2 tension.

The CO2 reactivity to hypocapnia when awake and during anaesthesia is calculated as the percentage change in internal carotid artery blood flow per kPa change in PaCO2. The CO2 reactivity when awake and when anaesthetized is compared.

Time Frame Four measurements; before induction of anaesthesia during normoventilation and during hyperventilation to reduce PaCO2 by 1.5 kPa and during anaesthesia at a PaCO2 at the value before induction of anaesthesia and 1.5 kPa below that value.
Hide Outcome Measure Data
Hide Analysis Population Description
Comparison of reactivity to hypocapnia when awake and during anaesthesia was evaluated by a linear mixed model with the relative change in ICA flow as outcome and fixed effects were the change in PaCO2 and an interaction factor for the difference between awake and anaesthesia. The reported result is the interaction factor.
Arm/Group Title Study of Cerebral Blood Flow
Hide Arm/Group Description:

Patients undergoing oesophageal- or ventricular resection (n=30)

Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Overall Number of Participants Analyzed 27
Mean (95% Confidence Interval)
Unit of Measure: %/kPa
7.4
(2.1 to 12.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study of Cerebral Blood Flow
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0068
Comments [Not Specified]
Method Linear mixed models
Comments [Not Specified]
9.Secondary Outcome
Title Changes in Heart Rate From Baseline Before Induction of Anaesthesia.
Hide Description Heart rate [bpm] as recorded continuously by a transducer connected to an arterial line.
Time Frame Continuous measurements from before induction of anaesthesia and until 2 hours after start of surgery.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study of Cerebral Blood Flow
Hide Arm/Group Description:

Patients undergoing oesophageal- or ventricular resection (n=30)

Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Overall Number of Participants Analyzed 27
Mean (95% Confidence Interval)
Unit of Measure: beats/min
-13
(-17 to -9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study of Cerebral Blood Flow
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method repeated measure mixed model
Comments [Not Specified]
10.Secondary Outcome
Title Changes in Mean Arterial Pressure From Baseline Before Induction of Anaesthesia.
Hide Description Mean arterial pressure [mmHg] as recorded continuously by a transducer connected to an arterial line.
Time Frame Continuous measurements from before induction of anaesthesia and until 2 hours after start of surgery.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study of Cerebral Blood Flow
Hide Arm/Group Description:

Patients undergoing oesophageal- or ventricular resection (n=30)

Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Overall Number of Participants Analyzed 27
Mean (95% Confidence Interval)
Unit of Measure: mmHg
-41
(-47 to 35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study of Cerebral Blood Flow
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
11.Secondary Outcome
Title Changes in Cardiac Output From Baseline Before Induction of Anaesthesia.
Hide Description Cardiac output [l/min] as evaluated continuously by pulse contour analysis of the arterial pressure curve (Modelflow).
Time Frame Continuous measurements from before induction of anaesthesia and until 2 hours after start of surgery.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study of Cerebral Blood Flow
Hide Arm/Group Description:

Patients undergoing oesophageal- or ventricular resection (n=30)

Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Overall Number of Participants Analyzed 27
Mean (95% Confidence Interval)
Unit of Measure: l/min
-2.7
(-3.4 to -2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study of Cerebral Blood Flow
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method repeated measure mixed model
Comments [Not Specified]
12.Secondary Outcome
Title Changes in Stroke Volume From Baseline Before Induction of Anaesthesia.
Hide Description Stroke volume [ml] as evaluated continuously by pulse contour analysis of the arterial pressure curve (Modelflow).
Time Frame Continuous measurements from before induction of anaesthesia and until 2 hours after start of surgery.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study of Cerebral Blood Flow
Hide Arm/Group Description:

Patients undergoing oesophageal- or ventricular resection (n=30)

Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Overall Number of Participants Analyzed 27
Mean (95% Confidence Interval)
Unit of Measure: ml
-24
(-34 to -14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study of Cerebral Blood Flow
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method repeated measure mixed model
Comments [Not Specified]
Time Frame Adverse event data were recorded during the patients stay in the operation room
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study of Cerebral Blood Flow
Hide Arm/Group Description

Patients undergoing oesophageal- or ventricular resection (n=30)

Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

All-Cause Mortality
Study of Cerebral Blood Flow
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Study of Cerebral Blood Flow
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study of Cerebral Blood Flow
Affected / at Risk (%)
Total   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Niels D. Olesen
Organization: Rigshospitalet
Phone: 004520262459
EMail: niels.damkjaer.olesen.01@regionh.dk
Publications:
Layout table for additonal information
Responsible Party: Niels Damkjær Olesen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02951273     History of Changes
Other Study ID Numbers: H-16036250
First Submitted: October 26, 2016
First Posted: November 1, 2016
Results First Submitted: October 6, 2017
Results First Posted: November 17, 2017
Last Update Posted: January 17, 2018