- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00446706
Estimation of Intrinsic Positive End-Expiratory Pressure (PEEP) in Acute Respiratory Distress Syndrome (ARDS)
ARDS (Acute Respiratory Distress Syndrome) is a condition of severe inflammation and excess fluids in the lungs that impairs their function of oxygen uptake to the point of needing a ventilator (breathing machine) to help them obtain enough oxygen into the body. Because of the high amounts of gas that the ventilator has to give to these patients, high pressures may develop deep into the lungs and produce complications for the patient. However, physicians sometimes cannot recognize it because it requires special equipment to measure pressure deep in the lungs. The goal of this study is to determine if the amount of this pressure can be calculated using mathematical formulas and the routine numbers provided by ventilators. The study consists on making the conventional measurement of this deep pressure and at the same time calculate this same pressure from other measurements that the ventilator routinely provides, to see if the calculated value can replace the more complicated conventional measurement. The measurements will be done by:
- placing a small device along the tubing connecting the patient to the ventilator;
- giving medicines to relax the muscles (if the patient is not already receiving them); and
- making the ventilator hold the patient's breath for a few seconds to take measurements.
This is repeated after the breathing rate of the ventilator is increased or decreased mildly. Risks related to the medicine to be used and the measuring maneuvers are rare but include transient narrowing of windpipes, transiently low heart rate, blood pressure or blood oxygen, and allergic reactions. This is not a treatment. The information obtained during the study will be shared with the treating doctors who may find it useful to make adjustments to the ventilator. The patient may receive no direct benefit from being in this study; however, the findings may contribute to better care for this kind of patients in the future.
연구 개요
상태
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Texas
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El Paso, Texas, 미국, 79905
- Thomason Hospital (Now University Medical Center)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients 18 years of age or older with diagnosis of ARDS, as defined by the American- European Consensus Conference 4
- Receiving mechanical ventilation.
- Presence of autoPEEP by inspection of flow-time waveforms displayed by the mechanical ventilator.
Exclusion Criteria:
- Known or suspected diagnosis of COPD or airflow limitation.
- Next of kin not available to consent.
- Contraindication to receive a muscle relaxant when measurements may be inaccurate without its administration.
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 전용
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Agreement between Measured and Estimated Intrinsic PEEP
기간: The day and time of measurement
|
Bias and its standard deviation
|
The day and time of measurement
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Juan Figueroa-Casas, MD, Texas Tech University
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 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- Estimation PEEPi
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .