The Feasibility and Accuracy of Exhaled CO2 to Measure Cardiac Output in Ventilated Patients Without Tracheal Intubation
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.
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.
연구 개요
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient is already monitored with a pulmonary artery catheter and arterial line (not for the purpose of this study);
- Hemodynamic stability.
Exclusion Criteria:
- 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;
- Patients who have claustrophobia and cannot wear the mask.
- Patients with aortic stenosis.
- Patients with left main coronary artery disease.
- Pregnancy.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 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.
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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To test the feasibility and accuracy of using NICO to measure cardiac output in ventilator assisted patients without tracheal intubation.
기간: 1 year
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1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Robert Kacmarek, PhD, RRT, Massachusetts General Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2007-P-000222
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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