Expert-Guided Early Tracheostomy Pathway

Not Applicable

Completed

• Conditions: Tracheostomy Complication; Respiratory Failure
• Interventions: Other: Expert-Guided Early Tracheostomy

• Registration Number: NCT05595707
• Lead Sponsor: Denver Health and Hospital Authority

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 Timeline

• Study Start: 2018-01-02
• Primary Completion: 2020-12-30
• Study Completion: 2022-09-30
• Study First Submitted: 2022-10-09
• Study First Submitted QC: 2022-10-23
• Study First Posted: 2022-10-27
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Early Percutaneous dilatational tracheostomy	Expert-Guided Early Tracheostomy	PDT reccomended for patients with high risk for prolonged mechanical ventilation.

Primary Outcome Measures

Name	Time	Method
Duration of hospitalization from admission to ventilator independent discharge	Hospital stay up to 90 days	Length of stay in days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

King Hussein Medical Center; 🇯🇴 Amman, Jordan