Tracheostomy Practice in Adult Intensive Care Units
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal College of Surgeons, Ireland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Greater than 18 years of age
Tracheostomy insertion during critical care admission
Disqualifiers
Tracheostomy prior to critical care admission
Elective tracheostomy insertion for head and neck pathology
Tracheostomy insertion for emergency surgical management of airway obstruction
Mini tracheostomy insertion only
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,500 Participants
are grouped into 1 trial groupGroup A: Critical care patients with a tracheostomy
Trial outcomes
Primary outcomes
1
Successful tracheostomy decannulation
The proportion of patients successfully decannulated from tracheostomy, censored at hospital discharge or 90 days, whichever comes first.
Time frame
90 daysSecondary outcomes
1
Time to decannulation
Time to successful decannulation censored at hospital discharge or 90 days, whichever comes first.
Time frame
90 days2
Mortality
Time frame
90 days3
Hospital utilization metrics
Duration of mechanical ventilation, ICU and hospital length of stay
Time frame
90 days4
Return to vocalisation
Measured by time in days to placement of a speaking valve
Time frame
90 daysSponsors and contacts
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Source ClinicalTrials.gov
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