Sedation and Ease of Weaning From Mechanical Ventilation

• ClinicalTrials.gov Identifier: NCT03406936
• Recruitment Status: Completed
• First Posted: January 23, 2018
• Last Update Posted: January 23, 2018
• Sponsor: Assiut University
• Information provided by (Responsible Party): Emad Zarief , MD, Assiut University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Respiratory Failure; Midazolam Overdose; Chronic Obstructive Pulmonary Disease; Weaning Failure	Drug: Daily interruption of midazolam	Not Applicable

Detailed 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 .

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Daily Interruption of Sedation Versus Non Sedation in Mechanically Ventilated Respiratory Failure Patients
• Actual Study Start Date: August 20, 2016
• Actual Primary Completion Date: June 28, 2017
• Actual Study Completion Date: October 30, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Daily interruption of sedation; Daily interruption of sedation will be done at 7 am daily by stoppage of midazolam infusion	Drug: Daily interruption of midazolam; daily at 7 am midazolam infusion will be stopped spontaneous breath trial will be done; Other Name: sedation interruption
No Intervention: No Sedation; No sedation will be given after initiation of mechanical ventilation

Outcome Measures

Primary Outcome Measures :

1. duration of mechanical ventilation [ Time Frame: first 30 days ]
   number of days of mechanical ventilation

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Obstructive lung disease
• Respiratory failure
• Invasive mechanical ventilation

Exclusion Criteria:

• Neurological deficit
• Cognitive dysfunction
• Extensive malignancy
• septic Shock

Contacts and Locations

Locations

Egypt

Emad Zarief Kamel Said

Assiut, Egypt, 71111

Sponsors and Collaborators

Assiut University

More Information

• Responsible Party: Emad Zarief , MD, Clinical professor, Assiut University
• ClinicalTrials.gov Identifier: NCT03406936
• Other Study ID Numbers: IRB00009917
• First Posted: January 23, 2018
• Last Update Posted: January 23, 2018
• Last Verified: January 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Midazolam; Adjuvants, Anesthesia; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; GABA Modulators; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action