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Trial record 6 of 570 for:    CARBON DIOXIDE AND anesthesia

Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia

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ClinicalTrials.gov Identifier: NCT03734822
Recruitment Status : Completed
First Posted : November 8, 2018
Results First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Anne May, Nationwide Children's Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Cystic Fibrosis
Interventions Other: End tidal CO2 (EtCO2)
Device: Transcutaneous CO2 (TCO2)
Diagnostic Test: Capillary CO2 (CapCO2)
Diagnostic Test: Arterial blood gas (ABG)
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cystic Fibrosis
Hide Arm/Group Description

Cystic fibrosis patients undergoing general anesthesia.

End tidal CO2 (EtCO2): End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.

Transcutaneous CO2 (TCO2): Continuous and noninvasive real-time monitoring of transcutaneous CO2.

Capillary CO2 (CapCO2): Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.

Arterial blood gas (ABG): Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer.

Period Title: Overall Study
Started 47
Completed 47
Not Completed 0
Arm/Group Title Cystic Fibrosis
Hide Arm/Group Description

Cystic fibrosis patients undergoing general anesthesia.

End tidal CO2 (EtCO2): End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.

Transcutaneous CO2 (TCO2): Continuous and noninvasive real-time monitoring of transcutaneous CO2.

Capillary CO2 (CapCO2): Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.

Arterial blood gas (ABG): Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer.

Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants
13.4  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
25
  53.2%
Male
22
  46.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants
47
BMI (kg/m2)  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m2
Number Analyzed 47 participants
18.7
(16.7 to 21.4)
FEV1%   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of normal
Number Analyzed 47 participants
87.3  (18.3)
[1]
Measure Description:

FEV1 is the maximal amount of air you can forcefully exhale in one second. It is then converted to a percentage of normal.

FEV1 greater 80% of predicted= normal, FEV1 60% to 79% of predicted = Mild obstruction, FEV1 40% to 59% of predicted = Moderate obstruction, FEV1 less than 40% of predicted = Severe obstruction

1.Primary Outcome
Title Accuracy of CO2 Levels
Hide Description Looking at the accuracy of CO2 levels assessed via end tidal CO2 (ETCO2), capillary CO2 (Cap-CO2), and transcutaneous CO2 (TCCO2) compared to arterial blood gas (ABG) which is the gold standard.
Time Frame Immediately following induction of anesthesia
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cystic Fibrosis
Hide Arm/Group Description:

Cystic fibrosis patients undergoing general anesthesia.

End tidal CO2 (EtCO2): End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.

Transcutaneous CO2 (TCO2): Continuous and noninvasive real-time monitoring of transcutaneous CO2.

Capillary CO2 (CapCO2): Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.

Arterial blood gas (ABG): Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer.

Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: mmHg
PaCO2 from ABG 48.9  (7.9)
ETCO2 39.5  (6.2)
TCCO2 41.5  (9.4)
Cap-CO2 44.3  (8.6)
Time Frame 1 day
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cystic Fibrosis
Hide Arm/Group Description

Cystic fibrosis patients undergoing general anesthesia.

End tidal CO2 (EtCO2): End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.

Transcutaneous CO2 (TCO2): Continuous and noninvasive real-time monitoring of transcutaneous CO2.

Capillary CO2 (CapCO2): Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.

Arterial blood gas (ABG): Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer.

All-Cause Mortality
Cystic Fibrosis
Affected / at Risk (%)
Total   0/47 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cystic Fibrosis
Affected / at Risk (%)
Total   0/47 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cystic Fibrosis
Affected / at Risk (%)
Total   0/47 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne May, MD
Organization: Nationwide Children's Hospital
Phone: 614-722-4766
EMail: Anne.May@nationwidechildrens.org
Layout table for additonal information
Responsible Party: Anne May, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03734822     History of Changes
Other Study ID Numbers: IRB15-00797
First Submitted: October 23, 2018
First Posted: November 8, 2018
Results First Submitted: January 28, 2019
Results First Posted: March 14, 2019
Last Update Posted: March 14, 2019