Sedation and Ease of Weaning From Mechanical Ventilation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Daily Interruption of Sedation Versus Non Sedation in Mechanically Ventilated Respiratory Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03406936
• Other study ID #: IRB00009917
• Status: Completed
• Phase: N/A
• First received: January 13, 2018
• Last updated: January 20, 2018
• Start date: August 20, 2016
• Est. completion date: October 30, 2017

Study information

• Verified date: January 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Daily interruption of sedation is one of the modalities which is known to enhance early weaning and separation from mechanical ventilation . Daily sedation interruption is also known to help decreasing incidence of ventilator associated pneumonia. The new modality is no sedation.

Description:

there is an increase of incidence of chronic obstructive lung disease associated respiratory failure which necessitates invasive mechanical ventilation. It is well known that one of the bundles for enhanced recovery of such cases is the daily interruption of sedation . Recently studies have demonstrated the feasibility of just using sedation for initiation of mechanical ventilation, then utilization of no sedation technique as a more this offers less side effects .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 30, 2017
• Est. primary completion date: June 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Obstructive lung disease

• Respiratory failure

• Invasive mechanical ventilation

Exclusion Criteria:

• Neurological deficit

• Cognitive dysfunction

• Extensive malignancy

• septic Shock

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Midazolam Overdose
• Pulmonary Disease, Chronic Obstructive
• Respiratory Failure
• Respiratory Insufficiency
• Weaning Failure

Intervention

Drug:
• Daily interruption of midazolam
daily at 7 am midazolam infusion will be stopped spontaneous breath trial will be done

Locations

Country	Name	City	State
Egypt	Emad Zarief Kamel Said	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of mechanical ventilation	number of days of mechanical ventilation	first 30 days