Actively Recruiting
No Sedation Versus Daily Interruption of Sedation in Chronic Obstructive Pulmonary Disease Mechanically Ventilated Patients - A Prospective Study
Led by Benha University · Updated on 2025-09-11
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two approaches to sedation in patients with Chronic Obstructive Pulmonary Disease (COPD) who need mechanical ventilation. The study evaluates no sedation versus daily interruption of sedation (DIS) to see which results in more ventilator-free days. This prospective study aims to improve care for COPD patients requiring ventilator support. One group of patients will be managed with a no sedation protocol, where agitation is addressed by identifying discomfort causes and managing them without physical restraints or sedation unless necessary. If agitation persists, a small dose of midazolam may be given, and if sedation is needed repeatedly, the patient will switch to the DIS protocol. The DIS group will have sedation managed daily with monitoring using the Richmond agitation and sedation score (RASS). Participants will be closely monitored from day 1 to day 28 for ventilator-free days. Researchers will observe sedation levels, agitation, and patient comfort. The study will follow patients throughout their ICU stay to assess outcomes related to sedation management, with no crossover between groups except as described. The total participation duration corresponds to the ventilation period and monitoring up to 28 days.
CONDITIONS
Brief Title
No Sedation Versus Daily Interruption of Sedation in Chronic Obstructive Pulmonary Disease Mechanically Ventilated Patients- A Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of both sexes aged 18 years or older
- Invasive mechanical ventilation
- Diagnosis of COPD confirmed by post-bronchodilator FEV1/FVC < 70
- COPD exacerbation admitted to ICU requiring invasive mechanical ventilation
- Study includes 60 patients divided into 2 equal groups
You will not qualify if you...
- Allergy to sedative medications
- Renal or hepatic impairment
- Proven or suspected psychiatric or neurological impairment
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive management with either no sedation or daily interruption of sedation while undergoing invasive mechanical ventilation for COPD exacerbation in the ICU.
Daily assessments during mechanical ventilation
Duration - Up to 28 days from day 1
Participants are monitored for ventilator-free days and recovery after treatment ends.
1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
Benha University Hospitals
Banhā, Qalyubia Governorate, Egypt, 13518
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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