Trials / Completed
CompletedNCT05595707
Expert-Guided Early Tracheostomy Pathway
Page 1/27 Effectiveness of an Expert-Guided Early Tracheostomy Pathway for Mechanically Ventilated Critically Ill Adults in Jordan
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 104 (actual)
- Sponsor
- Denver Health and Hospital Authority · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2018-01-02
- Primary completion
- 2020-12-30
- Completion
- 2022-09-30
- First posted
- 2022-10-27
- Last updated
- 2023-05-03
Locations
1 site across 1 country: Jordan
Source: ClinicalTrials.gov record NCT05595707. Inclusion in this directory is not an endorsement.