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

NCT01877941 | Completed Results

• 1 other identifier: UCSF 12-10139
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

The specific aim of this study is to assess whether a device approved by the FDA to measure pulse oximetry can accurately estimate cardiac output.

Conditions

Myocardial Infarction; Myocardial Ischemia

Keywords

cardiac output; pulse oximetry; hemodynamics

Outcome Measures

Primary Outcomes (3)

• esCCO (Estimated Continuous Cardiac Output) Monitor

  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)

  During and after surgery, up to 24 hours

• PAC (Pulmonary Artery Catheter).

  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)

  During and post-surgery, up to 24 hours

• Cardiac Output as Measured by ECOM

  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.

  During and post-surgery, up to 8 hours

Study Arms (1)

Cardiac output monitoring

ACTIVE COMPARATOR

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).

Device: Pulmonary Artery Catheter (PAC); Device: Endotracheal Cardiac Output Monitor (ECOM); Device: Estimated Continuous Cardiac Output (esCCO)

Interventions

Pulmonary Artery Catheter (PAC) DEVICE

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.

Cardiac output monitoring

Endotracheal Cardiac Output Monitor (ECOM) DEVICE

An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.

Cardiac output monitoring

Estimated Continuous Cardiac Output (esCCO) DEVICE

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.

Cardiac output monitoring

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing surgery where cardiac output will be measured with PAC and ECOM.

You may not qualify if:

• Failure to obtain consent.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Northern California Institute of Research and Education: collaborator
• San Francisco Veterans Affairs Medical Center: collaborator
• Drexel University: collaborator
• Nihon Kohden: collaborator

Study Sites (2)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

Myocardial Infarction; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Arthur Wallace, M.D., Ph.D.
• Organization: University of California San Francisco

art.wallace@va.gov

415-750-2069

Study Officials

• Arthur Wallace, MD, PhD

  San Francisco Veteran's Admnistration Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: June 14, 2013
• Study Start: December 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 1, 2015
• Results First Posted: January 1, 2015

Record last verified: 2014-12

Locations

US (2)