Chronic Obstructive Pulmonary Disease (COPD)NCT07146698
No Sedation Versus Daily Interruption of Sedation in Chronic Obstructive Pulmonary Disease Mechanically Ventilated Patients- A Prospective Study
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Sedation and Analgesia, run by Benha University at 1 site in Egypt.
Trial summary
this study is to compare no-sedation versus daily interruption of sedation (DIS) in Chronic obstructive pulmonary disease (COPD) patients receiving mechanical ventilation upon the ventilator-free days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Sedation and Analgesia
- What is being tested?
- daily Interruption of Sedation
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study will include 60 patients divided into 2 equal groups
Who may be able to join
- 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.
Who cannot join
- Allergy to sedative which will be used
- renal or hepatic impairment
- proven or suspected psychiatric or neurological impairment
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Benha University Hospitals
Banhā, Qalyubia Governorate, 13518
abeer abdelghany assistant lecturer, assistant lecturer, +201222928687, abeerabdulghani1994@gmail.com
About this study
this study is to compare no-sedation versus daily interruption of sedation (DIS) in Chronic obstructive pulmonary disease (COPD) patients receiving mechanical ventilation upon the ventilator-free days.
- Being tested
- daily Interruption of Sedation
- Keywords
- Choronic Obstructive Pulmonary disease (COPD), sedation and analgesia
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daily Interruption of SedationBehavioural
The patients will be managed by DIS. Richmond agitation and sedation score (RASS) will be used for monitoring the depth of sedation
| Study group | Role | What they receive |
|---|---|---|
| The patients will be managed by DIS. Richmond agitation and sedation score (RASS) will be used for m | This group of patients will be managed with the no sedation protocol. If agitation occurred, searching for a cause of patient discomfort will be carried out (e.g., tube obstruction or migration, hypoxia, and pain), and managed accordingly. The patient will be reassured and allowed to see his relatives for psychological support if needed, and physical restraints will never be used. If the patient remained agitated, he/she receive IV a bolus of midazolam of 0.5-5 mg as needed to get comfortable and calm. Afterwards, we will start a new trial of management with no sedation; if the sedation has to be repeated three times, we will keep the patient sedated by DIS protocol according to the control group protocol. We will not allow crossover between the groups. We will keep the shifted patients to the DIS protocol after failure of no-sedation protocol in their parent group according to the intention to treat principle. Receives: Behavioral: daily Interruption of Sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free days
Ventilator-free days (Number of days from day-1 to day-28) on which the patient did not need assistance to his breathe.
Measured: from day-1 to day-28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Nov 2024
- Primary completion30 Aug 2025
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Benha 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Abdulghani Soliman Mohammed Emara, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146698
- Sponsor's protocol ID
- MD 9-11-2024
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Sedation Versus Daily Interruption of Sedation in Chronic Obstructive Pulmonary Disease Mechanically Ventilated Patients- A Prospective Study
- ClinicalTrials.gov ID
- NCT07146698
- Acronym / sponsor ID
- MD 9-11-2024
- Keywords
- Choronic Obstructive Pulmonary disease (COPD), sedation and analgesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- Oct 2025 (estimated)
- First posted
- 28 Aug 2025 (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 is to compare no-sedation versus daily interruption of sedation (DIS) in Chronic obstructive pulmonary disease (COPD) patients receiving mechanical ventilation upon the ventilator-free days.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The patients will be managed by DIS. Richmond agitation and sedation score (RASS) will be used for m | – | Behavioral: daily Interruption of SedationThis group of patients will be managed with the no sedation protocol. If agitation occurred, searching for a cause of patient discomfort will be carried out (e.g., tube obstruction or migration, hypoxia, and pain), and managed accordingly. The patient will be reassured and allowed to see his relatives for psychological support if needed, and physical restraints will never be used. If the patient remained agitated, he/she receive IV a bolus of midazolam of 0.5-5 mg as needed to get comfortable and calm. Afterwards, we will start a new trial of management with no sedation; if the sedation has to be repeated three times, we will keep the patient sedated by DIS protocol according to the control group protocol. We will not allow crossover between the groups. We will keep the shifted patients to the DIS protocol after failure of no-sedation protocol in their parent group according to the intention to treat principle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 60 patients divided into 2 equal groups
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Allergy to sedative which will be used
- renal or hepatic impairment
- proven or suspected psychiatric or neurological impairment
- 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 |
|---|---|---|
| daily Interruption of SedationThe patients will be managed by DIS. Richmond agitation and sedation score (RASS) will be used for monitoring the depth of sedation | Behavioural | The patients will be managed by DIS. Richmond agitation and sedation score (RASS) will be used for m |
Primary outcome
Ventilator-free days
Time frame: from day-1 to day-28)
Ventilator-free days (Number of days from day-1 to day-28) on which the patient did not need assistance to his breathe.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Sedation and Analgesia, run by Benha 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Sep 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free days (time frame: from day-1 to day-28)). 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 11 Sep 2025.