NCT03406936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

January 13, 2018

Last Update Submit

January 20, 2018

Conditions

Respiratory FailureMidazolam OverdoseChronic Obstructive Pulmonary DiseaseWeaning Failure

Outcome Measures

Primary Outcomes (1)

  • duration of mechanical ventilation

    number of days of mechanical ventilation

    first 30 days

Study Arms (2)

Daily interruption of sedation

ACTIVE COMPARATOR

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

Drug: Daily interruption of midazolam

No Sedation

NO INTERVENTION

No sedation will be given after initiation of mechanical ventilation

Interventions

Daily interruption of midazolamDRUG

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

Also known as: sedation interruption
Daily interruption of sedation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obstructive lung disease
  • Respiratory failure
  • Invasive mechanical ventilation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Respiratory InsufficiencyPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

January 13, 2018

First Posted

January 23, 2018

Study Start

August 20, 2016

Primary Completion

June 28, 2017

Study Completion

October 30, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

EG(1)