Sedation vs No Sedation in Mechanically Ventilated COPD Patients

NCT07620912 | Completed Phase 2

• 1 other identifier: MSC/AZ.AST./CHT019/5/242/4/202
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; Respiratory Failure

Keywords

COPD; Mechanical ventilation; Sedation; No sedation

Outcome Measures

Primary Outcomes (1)

• Ventilator-free days during the first 28 days after initiation of mechanical ventilation

  Number of days alive and free from invasive mechanical ventilation within 28 days after enrollment.

  28 days after enrollment

Secondary Outcomes (3)

• Incidence of complications during ICU stay

  During ICU stay, assessed daily up to 28 days

• Length of ICU stay

  From ICU admission to ICU discharge, up to 28 days

• Difficulty of weaning from mechanical ventilation

  From initiation of weaning until successful liberation from mechanical ventilation or ICU discharge (up to 28 days)

Study Arms (2)

Daily Interruption of Sedation (DIS)

ACTIVE COMPARATOR

Patients will receive continuous sedation using midazolam infusion with daily interruption guided by the Richmond Agitation-Sedation Scale (RASS).

Drug: Midalozam

No Sedation Protocol

EXPERIMENTAL

Patients will be managed without continuous sedation.Sedation will be administered only if clinically indicated due to agitation or discomfort.

Drug: Midalozam

Interventions

Midalozam DRUG

Midazolam will be given as needed in bolus doses if agitation occurs.

Daily Interruption of Sedation (DIS); No Sedation Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University Hospital, Assiut

Asyut, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study with no masking. Both participants and investigators are aware of the assigned interventions
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Chest Diseases, ALAzher University Hospital, Assiut

Model Details: This is a retrospective randomized controlled trial in which 100 mechanically ventilated COPD patients will be randomly assigned into two parallel groups: daily interruption of sedation (DIS) group and no-sedation group, to compare clinical outcomes.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: June 2, 2026
• Study Start: April 14, 2025
• Primary Completion: April 7, 2026
• Study Completion: April 10, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)