Chronic Obstructive Pulmonary DiseasePhase 2SEDvsNO-COPDNCT07620912
Sedation vs No Sedation in Mechanically Ventilated COPD Patients
A Phase 2 study testing Midalozam in people with Chronic Obstructive Pulmonary Disease and Respiratory Failure, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Respiratory Failure
- What is being tested?
- Midalozam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Apr 2025to 10 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Known allergy to midazolam. Renal impairment. Hepatic impairment. Active malignancy (cancer). Psychiatric disorders. Neurological disorders. Pregnancy.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Midalozam
- Keywords
- COPD, Mechanical ventilation, Sedation, No sedation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidalozamDrug
Midazolam will be given as needed in bolus doses if agitation occurs.
| Study group | Role | What they receive |
|---|---|---|
| Daily Interruption of Sedation (DIS) | Active comparator | Patients will receive continuous sedation using midazolam infusion with daily interruption guided by the Richmond Agitation-Sedation Scale (RASS). Receives: Drug: Midalozam |
| No Sedation Protocol | Experimental | Patients will be managed without continuous sedation.Sedation will be administered only if clinically indicated due to agitation or discomfort. Receives: Drug: Midalozam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days after enrollment
Secondary outcomes (3)
Incidence of complications during ICU stay
Occurrence of complications including ventilator-associated pneumonia, hemodynamic instability, or need for reintubation during ICU stay.
Measured: 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.
Measured: 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.
Measured: From initiation of weaning until successful liberation from mechanical ventilation or ICU discharge (up to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start14 Apr 2025
- Primary completion7 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Anter Elsayed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620912
- Sponsor's protocol ID
- MSC/AZ.AST./CHT019/5/242/4/202
- Acronym
- SEDvsNO-COPD
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compareson Between Sedation and No Sedation in Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT07620912
- Acronym / sponsor ID
- SEDvsNO-COPD / MSC/AZ.AST./CHT019/5/242/4/202
- Keywords
- COPD, Mechanical ventilation, Sedation, No sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Daily Interruption of Sedation (DIS) | Active comparator | Drug: MidalozamPatients will receive continuous sedation using midazolam infusion with daily interruption guided by the Richmond Agitation-Sedation Scale (RASS). |
| No Sedation Protocol | Experimental | Drug: MidalozamPatients will be managed without continuous sedation.Sedation will be administered only if clinically indicated due to agitation or discomfort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Known allergy to midazolam. Renal impairment. Hepatic impairment. Active malignancy (cancer). Psychiatric disorders. Neurological disorders. Pregnancy.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidalozamMidazolam will be given as needed in bolus doses if agitation occurs. | Drug | Daily Interruption of Sedation (DIS), No Sedation Protocol |
Primary outcome
Ventilator-free days during the first 28 days after initiation of mechanical ventilation
Time frame: 28 days after enrollment
Number of days alive and free from invasive mechanical ventilation within 28 days after enrollment.
3 secondary outcomes
Incidence of complications during ICU stay
Time frame: During ICU stay, assessed daily up to 28 days
Length of ICU stay
Time frame: From ICU admission to ICU discharge, up to 28 days
Difficulty of weaning from mechanical ventilation
Time frame: From initiation of weaning until successful liberation from mechanical ventilation or ICU discharge (up to 28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Midalozam in people with Chronic Obstructive Pulmonary Disease and Respiratory Failure, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free days during the first 28 days after initiation of mechanical ventilation (time frame: 28 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.