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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Asyut, Egypte
- Al-Azhar University Hospital, Assiut
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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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Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Daily Interruption of Sedation (DIS)
Patients will receive continuous sedation using midazolam infusion with daily interruption guided by the Richmond Agitation-Sedation Scale (RASS).
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Midazolam will be given as needed in bolus doses if agitation occurs.
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Experimenteel: No Sedation Protocol
Patients will be managed without continuous sedation.Sedation will be administered only if clinically indicated due to agitation or discomfort.
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Midazolam will be given as needed in bolus doses if agitation occurs.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Ventilator-free days during the first 28 days after initiation of mechanical ventilation
Tijdsspanne: 28 days after enrollment
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Number of days alive and free from invasive mechanical ventilation within 28 days after enrollment.
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28 days after enrollment
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Incidence of complications during ICU stay
Tijdsspanne: During ICU stay, assessed daily up to 28 days
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Occurrence of complications including ventilator-associated pneumonia, hemodynamic instability, or need for reintubation during ICU stay.
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During ICU stay, assessed daily up to 28 days
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Length of ICU stay
Tijdsspanne: From ICU admission to ICU discharge, up to 28 days
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Duration of stay in the intensive care unit measured in days from ICU admission until discharge.
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From ICU admission to ICU discharge, up to 28 days
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Difficulty of weaning from mechanical ventilation
Tijdsspanne: From initiation of weaning until successful liberation from mechanical ventilation or ICU discharge (up to 28 days)
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Assessment of weaning difficulty based on duration of weaning process, number of spontaneous breathing trial failures, and need for prolonged mechanical ventilation.
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From initiation of weaning until successful liberation from mechanical ventilation or ICU discharge (up to 28 days)
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MSC/AZ.AST./CHT019/5/242/4/202
Plan Individuele Deelnemersgegevens (IPD)
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