Sedation vs No Sedation in Mechanically Ventilated COPD Patients (SEDvsNO-COPD)
Compareson Between Sedation and No Sedation in Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
연구 개요
상세 설명
Mechanical ventilation is a stressful experience for critically ill patients, often associated with pain, discomfort, and anxiety due to invasive procedures, environmental factors, and underlying disease. Sedation is commonly used in intensive care units to improve patient comfort and tolerance to mechanical ventilation. However, excessive sedation has been associated with prolonged mechanical ventilation, longer ICU stay, and increased complications.
Daily interruption of sedation (DIS) has been introduced to reduce sedation-related complications and improve outcomes. Recent trends support minimizing sedation and promoting patient comfort using alternative approaches. However, the optimal sedation strategy in patients with chronic obstructive pulmonary disease (COPD) remains unclear, especially in those with hypercapnic respiratory failure, where sedative drugs may worsen respiratory depression.
This study is a prospective randomized controlled trial conducted in the respiratory intensive care unit at Al-Azhar University Hospital, Assiut, Egypt 100 adult patients with COPD exacerbation requiring invasive mechanical ventilation will be enrolled and randomly assigned into two groups:
Group A (control group): Patients will receive sedation using midazolam infusion with daily interruption guided by the Richmond Agitation-Sedation Scale (RASS).
Group B (intervention group): Patients will be managed with a no-sedation protocol. Sedation will only be administered if clinically indicated due to agitation or discomfort.
All patients will receive standard medical treatment for COPD and will be monitored clinically and by laboratory and radiological investigations. Weaning from mechanical ventilation will be performed according to standard criteria.
The primary outcome is ventilator-free days. Secondary outcomes include ICU length of stay, incidence of complications, difficulty of weaning, and nursing workload.
Ethical approval has been obtained, and informed consent will be secured from patients or their legal representatives before enrollment.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Asyut, 이집트
- Al-Azhar University Hospital, Assiut
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Adult patients (≥18 years old). Patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring invasive mechanical ventilation.
Previously diagnosed COPD confirmed by post-bronchodilator FEV1/FVC < 70%. Patients admitted to the respiratory intensive care unit (ICU).
Exclusion Criteria:
Known allergy to midazolam. Renal impairment. Hepatic impairment. Active malignancy (cancer). Psychiatric disorders. Neurological disorders. Pregnancy.
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Daily Interruption of Sedation (DIS)
Patients will receive continuous sedation using midazolam infusion with daily interruption guided by the Richmond Agitation-Sedation Scale (RASS).
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Midazolam will be given as needed in bolus doses if agitation occurs.
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실험적: No Sedation Protocol
Patients will be managed without continuous sedation.Sedation will be administered only if clinically indicated due to agitation or discomfort.
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Midazolam will be given as needed in bolus doses if agitation occurs.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Ventilator-free days during the first 28 days after initiation of mechanical ventilation
기간: 28 days after enrollment
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Number of days alive and free from invasive mechanical ventilation within 28 days after enrollment.
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28 days after enrollment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of complications during ICU stay
기간: During ICU stay, assessed daily up to 28 days
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Occurrence of complications including ventilator-associated pneumonia, hemodynamic instability, or need for reintubation during ICU stay.
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During ICU stay, assessed daily up to 28 days
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Length of ICU stay
기간: From ICU admission to ICU discharge, up to 28 days
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Duration of stay in the intensive care unit measured in days from ICU admission until discharge.
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From ICU admission to ICU discharge, up to 28 days
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Difficulty of weaning from mechanical ventilation
기간: From initiation of weaning until successful liberation from mechanical ventilation or ICU discharge (up to 28 days)
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Assessment of weaning difficulty based on duration of weaning process, number of spontaneous breathing trial failures, and need for prolonged mechanical ventilation.
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From initiation of weaning until successful liberation from mechanical ventilation or ICU discharge (up to 28 days)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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
- MSC/AZ.AST./CHT019/5/242/4/202
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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