- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01165528
Adaptive Support Ventilation in Acute Respiratory Distress Syndrome (ARDS)
Adaptive Support Ventilation vs. Conventional Ventilation Strategy in the Management of Acute Respiratory Distress Syndrome:A Randomized Controlled Trial
Prospective randomized controlled trial to be conducted in the Respiratory Intensive Care Unit (RICU) of Post Graduate Institute of Medical Education And Research (PGIMER),Chandigarh. The study is approved by the Institute Ethics committee. In view of lack of previous outcome data in such patients, all patients requiring RICU admission for acute respiratory distress syndrome(ARDS) between January 2010 and June 2011 are being enrolled in this pilot study.
The patients meeting the aforementioned criteria will randomly assigned to ventilation with assist control mode ventilation (ACMV group) as per the ARDSnet strategy or adaptive support ventilation (ASV group). Being the first RCT of its type, patients will be first stabilized on ACMV for 1 hour to determine the adequate minute ventilation. The randomization sequence will be computer generated. The assignments will placed in sealed opaque envelopes and each patient's assignment was made on admission to the RICU by the attending physician. Blinding of treatment is not possible.
All patients will be ventilated only by Galileo Gold ventilators (Hamilton medical systems, Bonaduz, Switzerland). Patients randomized to the ACMV group will be ventilated according to low tidal volume strategy of 6ml/kg with Fio2/PEEP as per ARDSnet table to achieve a saturation between 88-95% with the lowest possible Fio2 to maintain plateau pressures < 30 cms H2o and PH > 7.3 with option to reduce tidal volume to 4 ml/kg and increase respiratory rate to 35/ min to achieve the above said goals11.These patients will be weaned as per standard protocol of spontaneous breathing trial of 30 minutes once they are recognized eligible as per statement of the sixth International consensus conference on weaning.
연구 개요
상세 설명
Inclusion criteria:
Study to include at least 40 patients admitted to RICU with diagnosis of ARDS as defined by American European consensus committee in 1994.
- Acute onset shortness of breath(<7 days)
- PaO2/FiO2 < 200 mm Hg (regardless of PEEP)
- Bilateral infiltrates on frontal chest radiograph
- <18 mm Hg when measured or no clinical evidence of left atrial hypertension
Exclusion criteria:
- Age less than 12 years
- Patients having underlying chronic lung disease (COPD, interstitial lung disease, pulmonary hypertension)
- Contraindication to permissive hypercapnea (raised intracranial pressure, acute cerebrovascular disorders, acute or chronic myocardial ischemia, right ventricular failure, uncorrected severe metabolic acidosis, sickle cell anemia, tricyclic antidepressant overdose, pregnancy)
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Chandigarh, 인도, 160012
- 모병
- Respiratory intensive care unit, PGIMER
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연락하다:
- Ritesh Agarwal, MD, DM, MAMS, FCCP
- 전화번호: 2756825 9914209825
- 이메일: riteshpgi@gmail.com
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수석 연구원:
- Arjun Srinivasan, M.D.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Acute onset shortness of breath(<7 days)
- PaO2/FiO2 < 200 mm Hg (regardless of PEEP)
- Bilateral infiltrates on frontal chest radiograph
- <18 mm Hg when measured or no clinical evidence of left atrial hypertension
Exclusion Criteria:
- Age less than 12 years
- Patients having underlying chronic lung disease
- Contraindication to permissive hypercapnia (raised intracranial pressure, acute cerebrovascular disorders, acute or chronic myocardial ischemia, right ventricular failure, uncorrected severe metabolic acidosis, sickle cell anemia, tricyclic antidepressant overdose, pregnancy)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Adaptive support ventilation in ARDS
patients of ARDS will be randomized to this arm to receive mechanical ventilation as per ASV protocol
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patients are randomized to receive one of the two types of mechanical ventilation for ARDS
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활성 비교기: conventional ventilation strategy in ARDS
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patients are randomized to receive one of the two types of mechanical ventilation for ARDS
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Duration of mechanical ventilation
기간: up to 4 weeks
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up to 4 weeks
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duration of ICU stay
기간: up to 4 weeks
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up to 4 weeks
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duration of hospital stay
기간: up to 8 weeks
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up to 8 weeks
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Mortality
기간: up to 8 weeks
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up to 8 weeks
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ease of use of ventilator mode
기간: up to 4 weeks
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up to 4 weeks
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frequency of blood gas analysis
기간: up to 4 weeks
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up to 4 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Arjun srinivasan, M.D., dept of pulmonary medicine & critical care, PGIMER
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- ASVtrial
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