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NCT07620912CompletedPhase 2

Sedation vs No Sedation in Mechanically Ventilated COPD Patients

Compareson Between Sedation and No Sedation in Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients

Source: ClinicalTrials.gov · Last updated 2 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
100 (actual)
First submitted
13 May 2026
Start date
14 Apr 2025
Primary completion date
7 Apr 2026
Lead sponsor
Al-Azhar University
Diseases
COPD
NCT number
NCT07620912

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 100
  • From 14 Apr 2025 to the primary completion date, 7 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known allergy to midazolam. Renal impairment. Hepatic impairment. Active malignancy (cancer). Psychiatric disorders. Neurological disorders. Pregnancy.

Other

  • \-

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Al-Azhar University Hospital, Assiut
Coordinator of this site? Confirm its status
AsyutEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.