No continuous sedation versus daily sedation interruption for ventilated COPD patients
No Sedation Versus Daily Interruption of Sedation in Chronic Obstructive Pulmonary Disease Mechanically Ventilated Patients- A Prospective Study
Benha University · NCT07146698
This compares no continuous sedation to daily sedation breaks to see which approach gives more ventilator-free days for adults with COPD on a breathing machine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Benha University (other) |
| Locations | 1 site (Banhā, Qalyubia Governorate) |
| Trial ID | NCT07146698 on ClinicalTrials.gov |
What this trial studies
This prospective comparison enrolls 60 adults with COPD exacerbation who require invasive mechanical ventilation at Benha University Hospitals. Participants are divided into two equal groups: one managed without continuous sedation and the other managed with daily interruption of sedation, with ventilator-free days as the primary outcome. Key exclusions include pregnancy, renal or hepatic impairment, neurological or psychiatric disorders, and allergy to the sedative. Patients are followed through their ICU course to capture ventilation duration and related clinical outcomes.
Who should consider this trial
Good fit: Adults (≥18 years) with COPD exacerbation requiring invasive mechanical ventilation admitted to the Benha University Hospitals ICU who do not have pregnancy, severe renal or hepatic impairment, neurological or psychiatric disorders, or allergy to the sedative.
Not a fit: Patients with significant renal or hepatic impairment, psychiatric or neurological disorders, pregnancy, or known sedative allergy are excluded and unlikely to benefit from these sedation strategies.
Why it matters
Potential benefit: If successful, this approach could shorten time on mechanical ventilation and reduce ICU complications related to prolonged sedation.
How similar studies have performed: Prior ICU studies in mixed critically ill populations have shown that no-sedation or daily sedation interruption can reduce ventilation time and ICU length of stay, but COPD-specific evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of both sex aged 18 years or older * The study will include 60 patients divided into 2 equal groups * Invasive mechanical ventilation * Patients with COPD patients (post-bronchodilator FEV1/FVC\< 70, and under follow through the department outpatient clinic) exacerbation admitted to the ICU and required invasive mechanical ventilation were recruited. Exclusion Criteria: Allergy to sedative which will be used * renal or hepatic impairment * proven or suspected psychiatric or neurological impairment * pregnancy
Where this trial is running
Banhā, Qalyubia Governorate
- Benha University Hospitals — Banhā, Qalyubia Governorate, Egypt (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Obstructive Pulmonary Disease, Sedation and Analgesia, Choronic Obstructive Pulmonary disease, sedation and analgesia