Tracheostomy Practice in Adult Intensive Care Units

NCT07769021 | Not Yet Recruiting

• 2 other identifiers: 26/54ESICM 2026 Lachmann Grant
• Study Type: observational
• Target: 2,500
• Locations: 8 countries
• Sites: 13

Brief Summary

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.

Conditions

Tracheostomy Patients; Tracheostomy Decannulation; Intensive Care (ICU)

Keywords

tracheostomy; decannulation; intensive care; prolonged mechanical ventilation; tracheostomy weaning; tracheostomy outcomes

Outcome Measures

Primary Outcomes (1)

• Successful tracheostomy decannulation

  The proportion of patients successfully decannulated from tracheostomy, censored at hospital discharge or 90 days, whichever comes first.

  90 days

Secondary Outcomes (7)

• Time to decannulation

  90 days

• Mortality

  90 days

• Hospital utilization metrics

  90 days

• Return to vocalisation

  90 days

• Return to oral intake

  90 days

Study Arms (1)

Critical care patients with a tracheostomy

Participants will include patients 18 years and older, admitted to the intensive care, who undergo tracheostomy insertion as part of their critical care admission.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Greater than 18 years of age
• Tracheostomy insertion during critical care admission

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (13)

Beth Israel Medical Centre

Boston, Massachusetts, 02215, United States

Location

University of Michigan Health Ann Arbor

Ann Arbor, Michigan, 48109, United States

Location

Nereu Ramos Hospital

Florianópolis, Brazil

Location

Toronto General Hospital

Toronto, Canada

Location

Tata Memorial Hospital

Mumbai, India

Location

Beaumont Hospital

Dublin, Ireland

Location

Mater Misericordiae University Hospital Dublin

Dublin, Ireland

Location

Galway University Hospital

Galway, Ireland

Location

Ospedale Policlinico San Martino Genoa

Genova, Italy

Location

University of Naples Frederico II

Naples, Italy

Location

University Hospital San Luigi Gonzaga Turin

Torino, Italy

Location

University Hospital of Lausanne

Lausanne, Switzerland

Location

Manchester University Hospital

Manchester, United Kingdom

Location

Related Publications (32)

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Related Links

• A study website including information for clinicians, researchers and participants. Links will be available to study documents and to register interest in participating as a site.

Central Study Contacts

Aisling Mc Mahon, MB BCh BAO FCAI FJFICMI

CONTACT

+35318032204; aislingmcmahon@mater.ie

Michelle Smyth, BSc

CONTACT

michellesmyth@rcsi.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 17, 2026
• Study Start (Estimated): November 2, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: August 17, 2026

Record last verified: 2026-07

Locations

CH (1); IT (3); IN (1); GB (1); IE (3); BR (1); CA (1); US (2)