About ON TRACH
ON TRACH – an Observational iNternational study of TRACHeostomy practice – is an international, multicentre, observational study with the aim of characterising the timing and practice of tracheostomy insertion, management, weaning and longer-term outcomes of these patients, in intensive care units internationally.
Study at a glance
Background
- Tracheostomy is common in critically ill patients requiring prolonged mechanical ventilation.
- Considerable variation exists in practices and outcomes across ICUs and countries.
- High-quality global data are needed to inform evidence-based care and improve patient outcomes.
Aims & objectives
Primary aim: to comprehensively characterise current tracheostomy practice and its variation internationally.
- Describe patient characteristics, tracheostomy practices, and clinical outcomes.
- Identify factors associated with key outcomes.
- Evaluate variation in practices and outcomes across ICUs and countries.
Study population
Adult ICU patients (18 years or older) who undergo tracheostomy during their ICU stay, across approximately 500 ICUs globally.
Methodology
- Prospective, observational cohort study.
- Consecutive eligible patients will be enrolled.
- Standardised data collection using an electronic case report form.
- Data collected from tracheostomy insertion to hospital discharge or day 90, whichever comes first.
Outcomes
Primary outcome
- Successful decannulation to discharge or day 90.
Secondary outcomes
- Mortality at 90 days
- Return to vocalisation, oral intake and mobilisation
- Hospital utilisation metrics
- Tracheostomy-related complications
Process outcomes
- Organisational structures of care
- Variation across ICUs and internationally
Optional modules
- Enhanced weaning dataset
- Long-term outcome dataset
Participant journey
From screening to completion of follow-up
1. Screening
- Mechanically ventilated patients in the ICU screened daily.
2. Enrollment
- Patient enrolled in the study on day 0, the day of tracheostomy insertion.
3. Baseline assessment
- Demographics
- Reason for ICU admission
- Severity of illness
- Tracheostomy insertion procedure
4. Core dataset (days 1, 3, 5, 7)
- Ventilator weaning
- Speech
- Oral intake
- Mobilisation
- Adverse events
5. Outcomes
- Primary outcome: successful decannulation, censored at hospital discharge, death or day 90
- Return to speech, swallow, mobilisation
- Adverse events
6. Optional long-term follow-up
- Clinical Frailty Score and EQ-5D-5L at 6 months
- Clinical Frailty Score and EQ-5D-5L at 12 months
Optional enhanced weaning module
Data collection on days 1, 3, 5, 7 and every 3rd day to day 28, followed by weekly to discharge, death or day 90.
Focus: ventilator weaning.
Optional long-term follow-up
Clinical Frailty Score and EQ-5D-5L collected at 6 and 12 months.
Study registration & responsible organisation
ON TRACH is coordinated by the Royal College of Surgeons in Ireland (RCSI), which acts as the study’s responsible organisation. The study is registered on ClinicalTrials.gov (NCT07769021), where the full registration record is publicly available.
Who can take part
Full eligibility criteria for participating sites and patients are set out in the ON TRACH study protocol. If you are part of an intensive care unit interested in joining the study, or have a question about eligibility, please get in touch with the study team.
Further protocol detail – including full ethical approval and funding information – will be added here as the protocol is finalised.