An observational study in Tracheostomy Patients, Tracheostomy Decannulation and Intensive Care (ICU), sponsored by Royal College of Surgeons, Ireland. Not yet recruiting at 13 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Royal College of Surgeons, Ireland · Observational
ON TRACH 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. Participating intensive care units (ICU) will recruit all consecutive patients undergoing tracheostomy insertion over a 12 week period, aiming for broad global representation. This will allow identification of variation in care of patients with a tracheostomy in the intensive care and it's origin, to drive improvement and enhance safety and outcomes for patients with a tracheostomy in the future.
Care of the patient with a tracheostomy is a core element of critical care practice. Around 20% of patients admitted to an intensive care unit (ICU) undergo tracheostomy insertion during their stay, typically in the context of prolonged mechanical ventilation and complex rehabilitation needs. Despite its frequent use and ongoing quality improvement initiatives, considerable variation in practice continues to exist and many questions with regards to tracheostomy timing, insertion, management and longer-term outcomes remain.
Variation exists not only because of patient characteristics, but also from an organisational perspective with diversity in hospital settings, system demands and governance structures. These inconsistencies lead to deficiencies in care and avoidable harm, increased morbidity and mortality.
This is an international multicentre prospective observational study to comprehensively characterise current tracheostomy practice. The study aims to describe the indications, timing, techniques, and management of tracheostomy insertion and care; to evaluate patient-centred outcomes and procedure-related adverse events; and to explore the organisational structures and models of care supporting tracheostomised patients in the ICU and beyond. This will allow us to identify variation in care, it's origin, drive improvement and enhance safety and outcomes for patients with a tracheostomy in the future.
Royal College of Surgeons, Ireland is the lead sponsor of 93 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients aged 18 years and older admitted in the intensive care unit after commencement of the enrolment period, and that are in receipt of invasive ventilator support, will be screened daily until ICU discharge or death. Those that undergo tracheostomy insertion during critical care admission will be included in the study.
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Exclusion Criteria:
Participants will include patients 18 years and older, admitted to the intensive care, who undergo tracheostomy insertion as part of their critical care admission.
Successful tracheostomy decannulation
The proportion of patients successfully decannulated from tracheostomy, censored at hospital discharge or 90 days, whichever comes first.
Time frame: 90 days
Time to decannulation
Time to successful decannulation censored at hospital discharge or 90 days, whichever comes first.
Time frame: 90 days
Mortality
Time frame: 90 days
Hospital utilization metrics
Duration of mechanical ventilation, ICU and hospital length of stay
Time frame: 90 days
Return to vocalisation
Measured by time in days to placement of a speaking valve
Time frame: 90 days
Return to oral intake
Measured using the Functional Oral Intake Scale (FOIS) which ranges from level 1 to 7, where level 1 is no oral intake and level 7 is full oral intake with no restrictions.
Time frame: 90 days
Return to mobilisation
Measured using the Intensive Care Mobility Scale which ranges from 1 to 10 with 10 indicating a greater degree of mobility.
Time frame: 90 days
Health related quality of life
Quality of life measured using the EuroQol five-dimensional questionnaire (EQ-5D-5L) with a lower score indicating a better quality of life.
Time frame: 3, 6 and 12 months
Plan to share: Undecided
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Royal College of Surgeons, Ireland