ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Evaluation of Cardiac Output Estimation Based on Pulse Wave Transit Time (esCCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01877941
Recruitment Status : Completed
First Posted : June 14, 2013
Results First Posted : January 1, 2015
Last Update Posted : January 1, 2015
Sponsor:
Collaborators:
Northern California Institute of Research and Education
San Francisco Veterans Affairs Medical Center
Drexel University
Nihon Kohden
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions Myocardial Infarction
Myocardial Ischemia
Interventions Device: Pulmonary Artery Catheter (PAC)
Device: Endotracheal Cardiac Output Monitor (ECOM)
Device: Estimated Continuous Cardiac Output (esCCO)
Enrollment 39

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cardiac Output Monitoring
Hide Arm/Group Description

Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).

Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.

Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.

Period Title: Overall Study
Started 39
Completed 39
Not Completed 0
Arm/Group Title Cardiac Output Monitoring
Hide Arm/Group Description

Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).

Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.

Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.

Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 39 participants
65
(55 to 80)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
  76.9%
>=65 years
9
  23.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
0
   0.0%
Male
39
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants
39
1.Primary Outcome
Title esCCO (Estimated Continuous Cardiac Output) Monitor
Hide Description

6 Measurements of cardiac output derived from pulse oximeter measurements using the esCCO system were taken at each time point. The measurements deemed valid under the criteria in the protocol were averaged to represent the reference value at that point. The mean and standard deviation reported consist of the reference values from all time points measured.

Data for this test were taken at the following timepoints:

1. Start of Sterenotomy; 2. Before Bypass; 3. 30 Min after bypass; 4. Closure; 5. ICU arrival; 6. 6 hours in ICU; 7. 12 Hours in ICU; 8. 18 Hours in ICU (if PAC still in); 9. 24 Hours in ICU (If PAC still in)

Time Frame During and after surgery, up to 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiac Output Monitoring
Hide Arm/Group Description:

Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).

Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.

Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.

Estimated Continuous Cardiac Output (esCCO): Sensors are placed on the arm, finger and leg to calculate Pulse Wave Transit Time (PWTT); the time it takes for the pulse of the heartbeat to travel through the body.

Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: liters/minute
5.6  (1.83)
2.Primary Outcome
Title PAC (Pulmonary Artery Catheter).
Hide Description

Measurements of cardiac output derived from a PAC (pulmonary artery catheter) using the standard thermodilution technique. At each time point, at least 6 measurements were taken. If, in the opinion of the clinician taking the readings, some of these were in error, more readings were taken to ensure accuracy. In no case were more than 18 readings taken. The points deemed valid by the clinician were averaged to obtain the reference value for that time point. The mean and standard deviation reported consisted of the reference values from all time points measured.

Data for this test were taken at the following timepoints:

1. Start of Sterenotomy; 2. Before Bypass; 3. 30 Min after bypass; 4. Closure; 5. ICU arrival; 6. 6 hours in ICU; 7. 12 Hours in ICU; 8. 18 Hours in ICU (if PAC still in); 9. 24 Hours in ICU (If PAC still in)

Time Frame During and post-surgery, up to 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiac Output Monitoring
Hide Arm/Group Description:

Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).

Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.

Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.

Estimated Continuous Cardiac Output (esCCO): Sensors are placed on the arm, finger and leg to calculate Pulse Wave Transit Time (PWTT); the time it takes for the pulse of the heartbeat to travel through the body.

Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: liters/minute
4.95  (1.39)
3.Primary Outcome
Title Cardiac Output as Measured by ECOM
Hide Description Measurements of cardiac output derived from the Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.
Time Frame During and post-surgery, up to 8 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Supplies for the ECOM device were not available so it was not tested.
Arm/Group Title Cardiac Output Monitoring
Hide Arm/Group Description:

Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).

Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.

Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame during surgery and during post-surgical recovery (up to 8 hours)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cardiac Output Monitoring
Hide Arm/Group Description

Patients undergoing surgery who will have their cardiac output monitored during surgery and during post-surgical recovery. For instance, patients with ischemic heart disease undergoing cardiac bypass graft or percutaneous coronary intervention.

No adverse events.

All-Cause Mortality
Cardiac Output Monitoring
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cardiac Output Monitoring
Affected / at Risk (%)
Total   0/39 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cardiac Output Monitoring
Affected / at Risk (%)
Total   0/39 (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
Name/Title: Arthur Wallace, M.D., Ph.D.
Organization: University of California San Francisco
Phone: 415-750-2069 ext 3732
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01877941     History of Changes
Other Study ID Numbers: UCSF 12-10139
First Submitted: December 5, 2012
First Posted: June 14, 2013
Results First Submitted: October 16, 2014
Results First Posted: January 1, 2015
Last Update Posted: January 1, 2015