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CompletedNCT03406936Updated Jan 23, 2018

Sedation and Ease of Weaning From Mechanical Ventilation

An interventional study of Daily interruption of midazolam in Respiratory Failure, Midazolam Overdose and Chronic Obstructive Pulmonary Disease, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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 .

02

Conditions studied

  • Respiratory Failure
  • Midazolam Overdose
  • Chronic Obstructive Pulmonary Disease
  • Weaning Failure
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Obstructive lung disease
  • Respiratory failure
  • Invasive mechanical ventilation

Exclusion criteria

Exclusion Criteria:

  • Neurological deficit
  • Cognitive dysfunction
  • Extensive malignancy
  • septic Shock
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • 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

  • No intervention
    No Sedation

    No sedation will be given after initiation of mechanical ventilation

Interventions

  • DrugDaily interruption of midazolam

    daily at 7 am midazolam infusion will be stopped spontaneous breath trial will be done

    Also known as: sedation interruption

05

What researchers measure

Primary outcomes

  1. duration of mechanical ventilation

    number of days of mechanical ventilation

    Time frame: first 30 days

06

Study locations

1 site
  • Emad Zarief Kamel Said
    Assiut, 71111, Egypt
07

Registry details

Key details

Study ID
NCT03406936
Lead sponsor
Assiut University
Responsible party
Emad Zarief , MD (Clinical professor, Assiut University) — Principal investigator
First posted
Jan 23, 2018
Start date
Aug 20, 2016
Primary completion
Jun 28, 2017
Completion
Oct 30, 2017
Last update
Jan 23, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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