Chronic Obstructive Pulmonary Disease, Respiratory Failure
Conditions
Keywords
COPD, Mechanical ventilation, Sedation, No sedation
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.
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.
Interventions
DRUGMidalozam
Midazolam will be given as needed in bolus doses if agitation occurs.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study with no masking. Both participants and investigators are aware of the assigned interventions
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free days during the first 28 days after initiation of mechanical ventilation | 28 days after enrollment | Number of days alive and free from invasive mechanical ventilation within 28 days after enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complications during ICU stay | During ICU stay, assessed daily up to 28 days | Occurrence of complications including ventilator-associated pneumonia, hemodynamic instability, or need for reintubation during ICU stay. |
| Length of ICU stay | From ICU admission to ICU discharge, up to 28 days | Duration of stay in the intensive care unit measured in days from ICU admission until discharge. |
| Difficulty of weaning from mechanical ventilation | From initiation of weaning until successful liberation from mechanical ventilation or ICU discharge (up to 28 days) | Assessment of weaning difficulty based on duration of weaning process, number of spontaneous breathing trial failures, and need for prolonged mechanical ventilation. |
Countries
Egypt
Outcome results
None listed