No Sedation Versus Daily Interruption of Sedation in Chronic Obstructive Pulmonary Disease Mechanically Ventilated Patients- A Prospective Study
NCT ID: NCT07146698
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2024-11-01
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
daily Interruption of Sedation
The patients will be managed by DIS. Richmond agitation and sedation score (RASS) will be used for monitoring the depth of sedation
Interventions
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daily Interruption of Sedation
The patients will be managed by DIS. Richmond agitation and sedation score (RASS) will be used for monitoring the depth of sedation
Eligibility Criteria
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Inclusion Criteria
* 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
* renal or hepatic impairment
* proven or suspected psychiatric or neurological impairment
* pregnancy
18 Years
ALL
No
Sponsors
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Benha University
OTHER
Responsible Party
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Abeer Abdulghani Soliman Mohammed Emara
assistant lecturer
Locations
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Benha University Hospitals
Banhā, Qalyubia Governorate, Egypt
Countries
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Facility Contacts
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abeer abdelghany assistant lecturer, assistant lecturer
Role: primary
Other Identifiers
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MD 9-11-2024
Identifier Type: -
Identifier Source: org_study_id
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