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Completed

NCT Number: NCT05595707

Expert-Guided Early Tracheostomy Pathway

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.

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Tracheostomy Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Hussein Medical Center

Amman, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Duration of hospitalization from admission to ventilator independent discharge

    Time frame: Hospital stay up to 90 days

    Length of stay in days

Secondary outcomes

  1. Easy or Moderately Easy to Wean

    Time frame: Hospital stay up to 90 days

    Numeric Score

  2. Days of ventilation requiring administration of NMB

    Time frame: Hospital stay up to 90 days

    Fraction of days when patient are mechanically ventilated and received NMB

  3. Difference in average and total morphine equivalent dose

    Time frame: Hospital stay up to 90 days

    Derived dose of morphine equivelants based on potency in mg

  4. 90 day survival

    Time frame: 90 days

    Survival recorded through 90 days from admission

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Collaborators

  • Denver Health Medical Center

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Oct 27, 2022
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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