Sedation vs No Sedation in Mechanically Ventilated COPD Patients (SEDvsNO-COPD)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Respiratory Failure
• Intervention / Treatment: Drug: Midalozam

Detailed Description

Mechanical ventilation is a stressful experience for critically ill patients, often associated with pain, discomfort, and anxiety due to invasive procedures, environmental factors, and underlying disease. Sedation is commonly used in intensive care units to improve patient comfort and tolerance to mechanical ventilation. However, excessive sedation has been associated with prolonged mechanical ventilation, longer ICU stay, and increased complications.

Daily interruption of sedation (DIS) has been introduced to reduce sedation-related complications and improve outcomes. Recent trends support minimizing sedation and promoting patient comfort using alternative approaches. However, the optimal sedation strategy in patients with chronic obstructive pulmonary disease (COPD) remains unclear, especially in those with hypercapnic respiratory failure, where sedative drugs may worsen respiratory depression.

This study is a prospective randomized controlled trial conducted in the respiratory intensive care unit at Al-Azhar University Hospital, Assiut, Egypt 100 adult patients with COPD exacerbation requiring invasive mechanical ventilation will be enrolled and randomly assigned into two groups:

Group A (control group): Patients will receive sedation using midazolam infusion with daily interruption guided by the Richmond Agitation-Sedation Scale (RASS).

Group B (intervention group): Patients will be managed with a no-sedation protocol. Sedation will only be administered if clinically indicated due to agitation or discomfort.

All patients will receive standard medical treatment for COPD and will be monitored clinically and by laboratory and radiological investigations. Weaning from mechanical ventilation will be performed according to standard criteria.

The primary outcome is ventilator-free days. Secondary outcomes include ICU length of stay, incidence of complications, difficulty of weaning, and nursing workload.

Ethical approval has been obtained, and informed consent will be secured from patients or their legal representatives before enrollment.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Asyut, Egypt
    • Al-Azhar University Hospital, Assiut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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).

Exclusion Criteria:

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Daily Interruption of Sedation (DIS); Patients will receive continuous sedation using midazolam infusion with daily interruption guided by the Richmond Agitation-Sedation Scale (RASS).	Drug: Midalozam; Midazolam will be given as needed in bolus doses if agitation occurs.
Experimental: No Sedation Protocol; Patients will be managed without continuous sedation.Sedation will be administered only if clinically indicated due to agitation or discomfort.	Drug: Midalozam; Midazolam will be given as needed in bolus doses if agitation occurs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of complications during ICU stay	Occurrence of complications including ventilator-associated pneumonia, hemodynamic instability, or need for reintubation during ICU stay.	During ICU stay, assessed daily up to 28 days
Length of ICU stay	Duration of stay in the intensive care unit measured in days from ICU admission until discharge.	From ICU admission to ICU discharge, up to 28 days
Difficulty of weaning from mechanical ventilation	Assessment of weaning difficulty based on duration of weaning process, number of spontaneous breathing trial failures, and need for prolonged mechanical ventilation.	From initiation of weaning until successful liberation from mechanical ventilation or ICU discharge (up to 28 days)

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2025
• Primary Completion (Actual): April 7, 2026
• Study Completion (Actual): April 10, 2026

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: COPD; Sedation; Mechanical ventilation; No sedation
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency
• Other Study ID Numbers: MSC/AZ.AST./CHT019/5/242/4/202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No