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

Cardiac Output Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00783679
• Other study ID #: 2007-P-000222
• Status: Withdrawn
• Phase: N/A
• First received: October 30, 2008
• Last updated: April 24, 2012
• Start date: November 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cardiac Output
• Cardiac Physiology

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test the feasibility and accuracy of using NICO to measure cardiac output in ventilator assisted patients without tracheal intubation.		1 year	No