No continuous sedation versus daily sedation interruption for ventilated COPD patients
Official title: No Sedation Versus Daily Interruption of Sedation in Chronic Obstructive Pulmonary Disease Mechanically Ventilated Patients- A Prospective Study
Run by Benha University · NCT07146698 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Benha University Academic / other |
| Locations | 1 site (Banhā, Qalyubia Governorate) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | August 30, 2025 |
| Study ends | October 2025 |
| Registry record updated | September 11, 2025 |
| Trial ID | NCT07146698 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Benha University Hospitals
Banhā, Qalyubia Governorate, Egypt Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Chronic Respiratory Disease Participant Engagement
This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.
-
IOS-based platform to screen, diagnose, and manage COPD and asthma
This study tests an Impulse Oscillometry system to screen for and diagnose COPD and asthma and to help predict flare-ups over about a year, involving adults in China.
-
Targeted NMES to improve breathing and leg/extra muscle strength in COPD
This study tests whether targeted neuromuscular electrical stimulation helps people with COPD see improvements in breathing muscle function and overall muscle strength.
-
AERO-007: a inhaled LABA+LAMA combination for COPD through a nebulizer
This study tests whether a nebulized LABA+LAMA combination can improve lung function in adults with COPD.
-
PBMT with a pulmonary rehab program for COPD patients
A small randomized trial tests whether adding photobiomodulation therapy before exercise in a COPD pulmonary rehab program helps improve functional capacity.
-
Controlled versus standard oxygen therapy for ICU COPD with acute exacerbation
This trial tests whether keeping oxygen levels at 88-92% helps ICU patients with an acute COPD flare more than keeping levels above 94%.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.