Expert-Guided Early Tracheostomy Pathway

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Respiratory Failure, Tracheostomy Complication

Intervention / Treatment
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* Other: Expert-Guided Early Tracheostomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Percutaneous dilatational tracheostomy<br>PDT reccomended for patients with high risk for prolonged mechanical ventilation. | Other: Expert-Guided Early Tracheostomy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalization from admission to ventilator independent discharge | Length of stay in days | Hospital stay up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Easy or Moderately Easy to Wean | Numeric Score | Hospital stay up to 90 days | 
| Days of ventilation requiring administration of NMB | Fraction of days when patient are mechanically ventilated and received NMB | Hospital stay up to 90 days | 
| Difference in average and total morphine equivalent dose | Derived dose of morphine equivelants based on potency in mg | Hospital stay up to 90 days | 
| 90 day survival | Survival recorded through 90 days from admission | 90 days |