Clinical Trial

Sedation vs No Sedation in Mechanically Ventilated COPD Patients

Study acronym: SEDvsNO-COPD
Completed Phase 2
View on ClinicalTrials.gov →
Summary
This study aims to evaluate the safety and efficacy of no-sedation compared to daily interruption of sedation (DIS) in mechanically ventilated patients with chronic obstructive pulmonary disease (COPD). Mechanical ventilation is associated with discomfort, anxiety, and agitation, often requiring sedation. However, excessive sedation may worsen outcomes, especially in COPD patients with respiratory failure. This randomized controlled trial will include 100 adult COPD patients admitted to the respiratory ICU and requiring invasive mechanical ventilation. Patients will be randomly assigned into two groups: one managed with daily interruption of sedation and the other managed with a no-sedation protocol. The primary outcome is ventilator-free days, while secondary outcomes include ICU length of stay, complications, difficulty of weaning, and nursing workload.
Trial Details
NCT Number NCT07620912
Lead Sponsor Al-Azhar University
Conditions Chronic Obstructive Pulmonary Disease, Respiratory Failure
Enrollment 100 participants
Start Date 2025-04-14
Primary Completion 2026-04-07 (estimated)
Study Completion 2026-04-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-02