- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02767687
Influence of Non Invasive Mechanical Ventilation on Tissue Perfusion in Patients After Cardiac Surgery
연구 개요
상세 설명
Patients submitted to open chest cardiac surgery will be enrolled after ICU admission. These patients will be submitted to noninvasive mechanical ventilation with continuous positive airway pressure right after extubation and tissue perfusion markers (central venous oxygen saturation (SVcO2) and lactate) will be obtained via central venous catheter.
Noninvasive mechanical ventilation is a common resource in the ICU to reduce extubation failures and to improve clinical outcomes, whether it can influence tissue perfusion remains unclear.
This study evaluates whether noninvasive ventilation affects tissue perfusion and whether tissue perfusion markers in the ICU are correlated with better clinical results for patients after heart surgery.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Presence of central venous catheter
- Invasive arterial pressure catheter
- Invasive mechanical ventilation
Exclusion Criteria:
- Chronic obstructive pulmonary disease
- Morbid obesity
- Hemodynamic instability
- Spontaneous breathing
- Need of invasive mechanical ventilation for more than 24 hours
- Intolerance to noninvasive mechanical ventilation
- Extubation failure
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Noninvasive ventilation (NIV)
Noninvasive mechanical ventilation is a resource used to treat respiratory failure or to reestablish respiratory comfort and function.
It is commonly used in the ICU with a regular mechanical ventilator and is offered using an interface that connects the machine to the patient.
The interface used for adults and in this study, was a silicon facial mask that covers the nose and mouth of the patient, allowing him or her to open the eyes.
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Twenty minutes after extubation all subjects will receive noninvasive ventilation delivered through a facial mask with an ICU ventilator with NIV option for 60 minutes.
NIV associates pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O).
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Evaluation of central venous oxygen saturation to determine tissue perfusion
기간: Through study completion, an average of 1 year
|
All patients will be admitted in ICU after surgery and will be submitted to four blood collections from the central venous catheter at different times to evaluate central venous oxygen saturation.
Time 1: at ICU admission in mechanical ventilation.
Time 2 : twenty minutes after extubation, before the noninvasive ventilation protocol, while breathing spontaneously with a 40% oxygen mask.
Time 3: At 60 minutes of noninvasive ventilation protocol.
Time 4: twenty minutes after noninvasive ventilation protocol complete while breathing spontaneously with a 40% oxygen mask.
The results will be compared between then to assess if there are changes under influence of non invasive ventilation.
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Through study completion, an average of 1 year
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Evaluation of arterial lactate to determine tissue perfusion
기간: Through study completion, an average of 1 year
|
All patients will be admitted in ICU after surgery and will be submitted to four blood collections from the arterial invasive catheter at different times to evaluate arterial lactate.
Time 1: at ICU admission in mechanical ventilation.
Time 2 : twenty minutes after extubation, before the noninvasive ventilation protocol, while breathing spontaneously with a 40% oxygen mask.
Time 3: At 60 minutes of noninvasive ventilation protocol.
Time 4: twenty minutes after noninvasive ventilation protocol complete while breathing spontaneously with a 40% oxygen mask.
The results will be compared between then to assess if there are changes under influence of non invasive ventilation.
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Through study completion, an average of 1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Respiratory complications during hospitalization
기간: Through study completion, an average of 1 year
|
Respiratory events as pleural effusion and atelectasis will be evaluated by a professional blind to the protocol of study and will be recorded.
|
Through study completion, an average of 1 year
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Hemodinamycs complications during hospitalization
기간: Through study completion, an average of 1 year
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Hemodinamycs events as arrhythmia, hypotension and cardiac arrest will be evaluated by a professional blind to the protocol of study and will be recorded.
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Through study completion, an average of 1 year
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공동 작업자 및 조사자
수사관
- 연구 책임자: Solange Guizilini, PhD, Federal University of São Paulo
간행물 및 유용한 링크
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
- 1.156.460
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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. .
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