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

Benha University

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease (COPD); Sedation and Analgesia

Treatments: Behavioral: daily Interruption of Sedation

Study type: Observational

Funder types: Other

Identifiers

NCT07146698

MD 9-11-2024

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

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

Description:

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.

Treatment:

Behavioral: daily Interruption of Sedation