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Sedation and Ease of Weaning From Mechanical Ventilation

Primary Purpose

Respiratory Failure, Midazolam Overdose, Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Daily interruption of midazolam
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Obstructive lung disease
  • Respiratory failure
  • Invasive mechanical ventilation

Exclusion Criteria:

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

Sites / Locations

  • Emad Zarief Kamel Said

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Daily interruption of sedation

No Sedation

Arm Description

Daily interruption of sedation will be done at 7 am daily by stoppage of midazolam infusion

No sedation will be given after initiation of mechanical ventilation

Outcomes

Primary Outcome Measures

duration of mechanical ventilation
number of days of mechanical ventilation

Secondary Outcome Measures

Full Information

First Posted
January 13, 2018
Last Updated
January 20, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03406936
Brief Title
Sedation and Ease of Weaning From Mechanical Ventilation
Official Title
Daily Interruption of Sedation Versus Non Sedation in Mechanically Ventilated Respiratory Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 20, 2016 (Actual)
Primary Completion Date
June 28, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Midazolam Overdose, Chronic Obstructive Pulmonary Disease, Weaning Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily interruption of sedation
Arm Type
Active Comparator
Arm Description
Daily interruption of sedation will be done at 7 am daily by stoppage of midazolam infusion
Arm Title
No Sedation
Arm Type
No Intervention
Arm Description
No sedation will be given after initiation of mechanical ventilation
Intervention Type
Drug
Intervention Name(s)
Daily interruption of midazolam
Other Intervention Name(s)
sedation interruption
Intervention Description
daily at 7 am midazolam infusion will be stopped spontaneous breath trial will be done
Primary Outcome Measure Information:
Title
duration of mechanical ventilation
Description
number of days of mechanical ventilation
Time Frame
first 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Obstructive lung disease Respiratory failure Invasive mechanical ventilation Exclusion Criteria: Neurological deficit Cognitive dysfunction Extensive malignancy septic Shock
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

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Sedation and Ease of Weaning From Mechanical Ventilation

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