Sedation and Ease of Weaning From Mechanical Ventilation

January 20, 2018 updated by: Emad Zarief , MD, Assiut University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Emad Zarief Kamel Said

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obstructive lung disease
  • Respiratory failure
  • Invasive mechanical ventilation

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • sedation interruption
NO_INTERVENTION: No Sedation
No sedation will be given after initiation of mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of mechanical ventilation
Time Frame: first 30 days
number of days of mechanical ventilation
first 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 20, 2016

Primary Completion (ACTUAL)

June 28, 2017

Study Completion (ACTUAL)

October 30, 2017

Study Registration Dates

First Submitted

January 13, 2018

First Submitted That Met QC Criteria

January 20, 2018

First Posted (ACTUAL)

January 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 20, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00009917

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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