Expert-Guided Early Tracheostomy Pathway

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05595707
• Other study ID #: Trachtime22
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2023
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 30, 2022
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency
• Tracheostomy Complication

Intervention

Other:
• Expert-Guided Early Tracheostomy
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).

Locations

Country	Name	City	State
Jordan	King Hussein Medical Center	Amman

Sponsors (2)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	Denver Health Medical Center

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of hospitalization from admission to ventilator independent discharge	Length of stay in days	Hospital stay up to 90 days
Secondary	Easy or Moderately Easy to Wean	Numeric Score	Hospital stay up to 90 days
Secondary	Days of ventilation requiring administration of NMB	Fraction of days when patient are mechanically ventilated and received NMB	Hospital stay up to 90 days
Secondary	Difference in average and total morphine equivalent dose	Derived dose of morphine equivelants based on potency in mg	Hospital stay up to 90 days
Secondary	90 day survival	Survival recorded through 90 days from admission	90 days