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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05595707
Enrollment
104
Registered
2022-10-27
Start date
2018-01-02
Completion date
2022-09-30
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure, Tracheostomy Complication

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.

Interventions

OTHERExpert-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).

Sponsors

Denver Health Medical Center
CollaboratorOTHER
Denver Health and Hospital Authority
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of hospitalization from admission to ventilator independent dischargeHospital stay up to 90 daysLength of stay in days

Secondary

MeasureTime frameDescription
Easy or Moderately Easy to WeanHospital stay up to 90 daysNumeric Score
Days of ventilation requiring administration of NMBHospital stay up to 90 daysFraction of days when patient are mechanically ventilated and received NMB
Difference in average and total morphine equivalent doseHospital stay up to 90 daysDerived dose of morphine equivelants based on potency in mg
90 day survival90 daysSurvival recorded through 90 days from admission

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026