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Clinical Trials/NCT05595707
NCT05595707CompletedNot Applicable

Page 1/27 Effectiveness of an Expert-Guided Early Tracheostomy Pathway for Mechanically Ventilated Critically Ill Adults in Jordan

Denver Health and Hospital Authority1 site in 1 country104 target enrollmentStarted: January 2, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
104
Locations
1
Primary Endpoint
Duration of hospitalization from admission to ventilator independent discharge

Study Overview

Brief Summary

The optimal timing of tracheostomy insertion remains uncertain. We hypothesized that a clinical pathway including expert-informed risk assessment regarding predicted duration of mechanical (MV) would enhance the effectiveness of early percutaneous dilatational tracheostomy (PDT) for patients with anticipated prolonged durations of MV, as reflected by duration of ventilation, complications, and patient-centered outcomes.

Detailed Description

three-year prospective observational study (2018-2020) at a tertiary care level 1 trauma center (King Hussein Medical Center) in Amman Jordan and 4 affiliated subspecialty hospitals. The study sequentially enrolled all adult patients (>18yo) with critical illness receiving MV in an intensive care unit for 48 hours or longer. Institutional ethical committee clearance for the study was secured.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients undergoing continued MV for 48 or more hours for whom continuation of life-prolonging therapy was indicated

Exclusion Criteria

  • •Patients at imminent risk of death were included

Arms & Interventions

Early Percutaneous dilatational tracheostomy

Experimental

PDT reccomended for patients with high risk for prolonged mechanical ventilation.

Intervention: Expert-Guided Early Tracheostomy (Other)

Outcomes

Primary Outcomes

Duration of hospitalization from admission to ventilator independent discharge

Time Frame: Hospital stay up to 90 days

Length of stay in days

Secondary Outcomes

  • Days of ventilation requiring administration of NMB(Hospital stay up to 90 days)
  • Difference in average and total morphine equivalent dose(Hospital stay up to 90 days)
  • 90 day survival(90 days)
  • Easy or Moderately Easy to Wean(Hospital stay up to 90 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ivor Douglas

Professor

Denver Health and Hospital Authority

Study Sites (1)

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