Expert-Guided Early Tracheostomy Pathway

NCT05595707 | Completed

• 1 other identifier: Trachtime22
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Tracheostomy Complication

Outcome Measures

Primary Outcomes (1)

• Duration of hospitalization from admission to ventilator independent discharge

  Length of stay in days

  Hospital stay up to 90 days

Secondary Outcomes (4)

• Easy or Moderately Easy to Wean

  Hospital stay up to 90 days

• 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

Study Arms (1)

Early Percutaneous dilatational tracheostomy

EXPERIMENTAL

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

Other: Expert-Guided Early Tracheostomy

Interventions

Expert-Guided Early Tracheostomy OTHER

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).

Early Percutaneous dilatational tracheostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients at imminent risk of death were included

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• Denver Health Medical Center: collaborator

Study Sites (1)

King Hussein Medical Center

Amman, Jordan

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 9, 2022
• First Posted: October 27, 2022
• Study Start: January 2, 2018
• Primary Completion: December 30, 2020
• Study Completion: September 30, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)