The Feasibility and Accuracy of Exhaled CO2 to Measure Cardiac Output in Ventilated Patients Without Tracheal Intubation

This study has been withdrawn prior to enrollment.
(Understaffing and inadequate funding)
Sponsor:
Information provided by (Responsible Party):
Robert M. Kacmarek, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00783679
First received: October 30, 2008
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to test the accuracy of a new noninvasive way to measure how much blood our heart pumps per minute. This new way measures the heart's pumping activity from outside the body, instead of breaking the skin and measuring it from the inside.

Subjects will breathe normally through a mask while we record how fast and how much air they are breathing. We will have them "re-breathe" some of the air they breathed out by adjusting the ventilator. During this time, we will use the air breathed out to calculate how much blood per minute the subject's heart is pumping. We will also measure how much blood the heart is pumping at this time by injecting fluid into the catheter in the neck and then drawing about 1 teaspoon of blood from the catheters in the neck and arm. We will compare the calculated and measured values of the amount of blood pumped out of the heart for accuracy.

After we complete this procedure, we will remove the mask and allow you to rest for 10-30min. Following the rest period, we will repeat the process and collect a second set of measurements. We will draw a total of 4 teaspoons of blood for the study.

If you cannot comfortably breathe along with the ventilator, we will withdraw you from the study. If you want to stop taking part in the study at any time, let the study doctor know that you wish to withdraw. We will take off the mask, and your time in the study will end. This decision will not affect your regular medical care.


Condition Intervention
Cardiac Physiology
Cardiac Output
Device: NICO device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Determining the Feasibility and Accuracy of Exhaled CO2 to Measure Cardiac Output in Ventilated Patients Without Tracheal Intubation

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To test the feasibility and accuracy of using NICO to measure cardiac output in ventilator assisted patients without tracheal intubation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Twenty adult spontaneously breathing patients without intubation and mechanical ventilation recruited from the cardiac catheterization laboratory. All will be post-heart-transplant patients coming for yearly evaluation.
Device: NICO device

Measurement of cardiac output and simultaneous blood sampling.

The subjects' cardiac output will be measured by NICO device and also by thermodilution method. Simultaneously blood samples will be drawn from the pulmonary artery catheter and arterial line. The calculated and measured cardiac output values will be compared for accuracy.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is already monitored with a pulmonary artery catheter and arterial line (not for the purpose of this study);
  2. Hemodynamic stability.

Exclusion Criteria:

  1. Patients with facial deformity, heavy beard or moustache which prevents good seal between the mask and the face;
  2. Patients who have central nervous system disorders that might be adversely affected by CO2 rebreathing, such as head trauma patients with increased intracranial pressure;
  3. Patients with severe tricuspid regurgitation;
  4. Patients with intra-cardiac shunts;
  5. Patients who cannot cooperate and synchronize with the ventilator;
  6. Patients with unstable respiratory conditions, such as acute respiratory failure;
  7. Patients who have claustrophobia and cannot wear the mask.
  8. Patients with aortic stenosis.
  9. Patients with left main coronary artery disease.
  10. Pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783679

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Robert Kacmarek, PhD, RRT Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Robert M. Kacmarek, Professor of Anesthesia, Director of Respiratory Care Services, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00783679     History of Changes
Other Study ID Numbers: 2007-P-000222
Study First Received: October 30, 2008
Last Updated: April 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Cardiac output
Noninvasive cardiac output measurement
Thermodilution

ClinicalTrials.gov processed this record on July 28, 2014