No Sedation Versus Daily Interruption of Sedation in Chronic Obstructive Pulmonary Disease Mechanically Ventilated Patients- A Prospective Study

NCT07146698 | Recruiting DMC

• 1 other identifier: MD 9-11-2024
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Sedation and Analgesia

Keywords

Choronic Obstructive Pulmonary disease (COPD); sedation and analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

  from day-1 to day-28)

Study Arms (1)

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.

Behavioral: daily Interruption of Sedation

Interventions

daily Interruption of Sedation BEHAVIORAL

The patients will be managed by DIS. Richmond agitation and sedation score (RASS) will be used for monitoring the depth of sedation

The patients will be managed by DIS. Richmond agitation and sedation score (RASS) will be used for m

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include 60 patients divided into 2 equal groups

You may qualify if:

• 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.

You may not qualify if:

• Allergy to sedative which will be used
• renal or hepatic impairment
• proven or suspected psychiatric or neurological impairment
• pregnancy

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospitals

Banhā, Qalyubia Governorate, 13518, Egypt

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Agnosia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: November 1, 2024
• Primary Completion: August 30, 2025
• Study Completion: October 1, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

EG (1)