Expert-Guided Early Tracheostomy Pathway
Primary Purpose
Respiratory Failure, Tracheostomy Complication
Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Expert-Guided Early Tracheostomy
Sponsored by
About this trial
This is an interventional health services research trial for Respiratory Failure
Eligibility Criteria
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
Sites / Locations
- King Hussein Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Early Percutaneous dilatational tracheostomy
Arm Description
PDT reccomended for patients with high risk for prolonged mechanical ventilation.
Outcomes
Primary Outcome Measures
Duration of hospitalization from admission to ventilator independent discharge
Length of stay in days
Secondary Outcome Measures
Easy or Moderately Easy to Wean
Numeric Score
Days of ventilation requiring administration of NMB
Fraction of days when patient are mechanically ventilated and received NMB
Difference in average and total morphine equivalent dose
Derived dose of morphine equivelants based on potency in mg
90 day survival
Survival recorded through 90 days from admission
Full Information
NCT ID
NCT05595707
First Posted
October 9, 2022
Last Updated
May 1, 2023
Sponsor
Denver Health and Hospital Authority
Collaborators
Denver Health Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05595707
Brief Title
Expert-Guided Early Tracheostomy Pathway
Official Title
Page 1/27 Effectiveness of an Expert-Guided Early Tracheostomy Pathway for Mechanically Ventilated Critically Ill Adults in Jordan
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Denver Health and Hospital Authority
Collaborators
Denver Health Medical Center
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Tracheostomy Complication
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early Percutaneous dilatational tracheostomy
Arm Type
Experimental
Arm Description
PDT reccomended for patients with high risk for prolonged mechanical ventilation.
Intervention Type
Other
Intervention Name(s)
Expert-Guided Early Tracheostomy
Intervention Description
Patients judged to be at moderate to high risk of prolonged ventilation(26, 27) were those who had chronic respiratory failure, advanced Effectiveness of an Expert-Guided Early Tracheostomy Pathway Page 6/27 age, thrombocytopenia or coagulopathy, persistent vasopressor shock, requirement for renal replacement therapy, an admission trauma diagnosis amongst other criteria, were included. In the absence of these criteria, a consensus for low risk of prolonged MV was reached. Early PDT, within the first 7 days from intubation, was recommended for patients with a moderate/high risk of prolonged MV (Early Group). Continued MV by ETT was recommend for low-risk patients with the potential for delayed PDT in the event of delayed weaning and liberation (Late Group).
Primary Outcome Measure Information:
Title
Duration of hospitalization from admission to ventilator independent discharge
Description
Length of stay in days
Time Frame
Hospital stay up to 90 days
Secondary Outcome Measure Information:
Title
Easy or Moderately Easy to Wean
Description
Numeric Score
Time Frame
Hospital stay up to 90 days
Title
Days of ventilation requiring administration of NMB
Description
Fraction of days when patient are mechanically ventilated and received NMB
Time Frame
Hospital stay up to 90 days
Title
Difference in average and total morphine equivalent dose
Description
Derived dose of morphine equivelants based on potency in mg
Time Frame
Hospital stay up to 90 days
Title
90 day survival
Description
Survival recorded through 90 days from admission
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
King Hussein Medical Center
City
Amman
Country
Jordan
12. IPD Sharing Statement
Plan to Share IPD
No
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Expert-Guided Early Tracheostomy Pathway
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