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Sedation vs No Sedation in Mechanically Ventilated COPD Patients
Sponsor: Al-Azhar University
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.
Official title: Compareson Between Sedation and No Sedation in Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-04-14
Completion Date
2026-04-10
Last Updated
2026-06-02
Healthy Volunteers
No
Interventions
Midalozam
Midazolam will be given as needed in bolus doses if agitation occurs.
Locations (1)
Al-Azhar University Hospital, Assiut
Asyut, Egypt