- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02326649
Noninvasive Measurement of CO Using Impedance Cardiography in Patients With CHD
Noninvasive Measurement of Cardiac Output Using Impedance Cardiography in Patients With Congenital Heart Disease
연구 개요
상세 설명
The measurement of cardiac output (CO) is important for a wide variety of patients under multiple conditions. At present, gold standard techniques for measurement of CO include velocity encoded phase contrast MRI. Both of these techniques are valid in patients with structural CHD. Disadvantages of these techniques include the requirement of significant time and expertise, and the high cost and anesthesia requirement. Accurate, non-invasive tools to measure CO could be extremely valuable for patients with CHD that require one-time of continuous monitoring of CO, such as during surgery, in intensive care settings, during other diagnostic testing, and during different physiologic states such as sleep and exercise. This study would begin by comparing cardiac output based on the PhysioFlow monitor to cardiac outout by MRI.
Impedance cardiography is performed by placing electrodes on the thorax and neck to measure electrical impedance over time. Cardiac output is derived from these measurements. The technique has been studied, validated, and used extensively in adults and has also been shown to be valid in children with structurally normal hearts. In contrast, recent studies of children with CHD have shown a relatively poor agreement between impedance cardiography and both thermodilution technique and velocity encoded phase contrast MRI. The reasons for the poor agreement in CHD patients is not yet understood. There are proprietary algorithms in each impedance device that use the raw data to calculate and report cardiac output. If the physiologic and/or anatomic differences of patients with CHD require changing the algorithm within each system to account for such differences, that needs to be done to each system. In order to do this, owners of any given device (PhysioFlow, NeuMeDx Inc. in this case) need access to the raw data in order to alter the algorithm. This study will involve a concerted effort between investigators at RCHSD, UCSD, and NeuMeDx
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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California
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San Diego, California, 미국, 92123
- Rady Children's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Any form of congenital heart disease
- Any age
Exclusion Criteria:
- Subjects with significant clinical skin reactions to electrodes such as excessive pain and/or skin inflammation, or significant previous skin reaction
- Subjects who are not able to provide consent
- Subjects with pacemaker
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
CHD patients undergoing cardiac MRI without sedation
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impedance cardiography instrument that measures cardiac output non-invasively
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean Difference in Stroke Volume Between CMR and SMIC
기간: 2 hours
|
Mean difference in stroke volume (SV) between CMR and SMIC measurements in ml
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2 hours
|
공동 작업자 및 조사자
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .