Cardiac PhysiologyNCT00783679
The Feasibility and Accuracy of Exhaled CO2 to Measure Cardiac Output in Ventilated Patients Without Tracheal Intubation
A study testing NICO device in people with Cardiac Physiology and Cardiac Output, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Physiology, Cardiac Output
- What is being tested?
- NICO device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is already monitored with a pulmonary artery catheter and arterial line (not for the purpose of this study);
- Hemodynamic stability.
Who cannot join
- Patients with facial deformity, heavy beard or moustache which prevents good seal between the mask and the face;
- Patients who have central nervous system disorders that might be adversely affected by CO2 rebreathing, such as head trauma patients with increased intracranial pressure;
- Patients with severe tricuspid regurgitation;
- Patients with intra-cardiac shunts;
- Patients who cannot cooperate and synchronize with the ventilator;
- Patients with unstable respiratory conditions, such as acute respiratory failure;
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- Patients who have claustrophobia and cannot wear the mask.
- Patients with aortic stenosis.
- Patients with left main coronary artery disease.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Determining the Feasibility and Accuracy of Exhaled CO2 to Measure Cardiac Output in Ventilated Patients Without Tracheal Intubation
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.
Read more
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.
- Conditions
- Cardiac Physiology, Cardiac Output
- Being tested
- NICO device
- Keywords
- Cardiac output, Noninvasive cardiac output measurement, Thermodilution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NICO deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | 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. Receives: Device: NICO device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the feasibility and accuracy of using NICO to measure cardiac output in ventilator assisted patients without tracheal intubation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Understaffing and inadequate funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac PhysiologyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert M. Kacmarek, Massachusetts General Hospital
- Investigators
- Robert Kacmarek, PhD, RRT, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783679
- Sponsor's protocol ID
- 2007-P-000222
- Status last verified
- Apr 2012
- First submitted
- 30 Oct 2008
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Feasibility and Accuracy of Exhaled CO2 to Measure Cardiac Output in Ventilated Patients Without Tracheal Intubation
- ClinicalTrials.gov ID
- NCT00783679
- Acronym / sponsor ID
- 2007-P-000222
- Conditions
- Cardiac Physiology, Cardiac Output
- Keywords
- Cardiac output, Noninvasive cardiac output measurement, Thermodilution
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Understaffing and inadequate funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: NICO deviceTwenty 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is already monitored with a pulmonary artery catheter and arterial line (not for the purpose of this study);
- Hemodynamic stability.
Key exclusion criteria (10 listed)
- Patients with facial deformity, heavy beard or moustache which prevents good seal between the mask and the face;
- Patients who have central nervous system disorders that might be adversely affected by CO2 rebreathing, such as head trauma patients with increased intracranial pressure;
- Patients with severe tricuspid regurgitation;
- Patients with intra-cardiac shunts;
- Patients who cannot cooperate and synchronize with the ventilator;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NICO deviceMeasurement 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. | Device | 1 |
Primary outcome
To test the feasibility and accuracy of using NICO to measure cardiac output in ventilator assisted patients without tracheal intubation.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Kacmarek, PhD, RRT principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NICO device in people with Cardiac Physiology and Cardiac Output, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test the feasibility and accuracy of using NICO to measure cardiac output in ventilator assisted patients without tracheal intubation. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2012.