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NCT Number: NCT07769021

Tracheostomy Practice in Adult Intensive Care Units

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nereu Ramos Hospital, Florianópolis, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Successful tracheostomy decannulation

    Time frame: 90 days

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

Secondary outcomes

  1. Time to decannulation

    Time frame: 90 days

    Time to successful decannulation censored at hospital discharge or 90 days, whichever comes first.

  2. Mortality

    Time frame: 90 days

  3. Hospital utilization metrics

    Time frame: 90 days

    Duration of mechanical ventilation, ICU and hospital length of stay

  4. Return to vocalisation

    Time frame: 90 days

    Measured by time in days to placement of a speaking valve

  5. Return to oral intake

    Time frame: 90 days

    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.

  6. Return to mobilisation

    Time frame: 90 days

    Measured using the Intensive Care Mobility Scale which ranges from 1 to 10 with 10 indicating a greater degree of mobility.

  7. Health related quality of life

    Time frame: 3, 6 and 12 months

    Quality of life measured using the EuroQol five-dimensional questionnaire (EQ-5D-5L) with a lower score indicating a better quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Aisling Mc Mahon, MB BCh BAO FCAI FJFICMI

CONTACT

[email protected]

+35318032204

Michelle Smyth, BSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Registry information

Official study title

Observational iNternational Study of TRACHeostomy Practice in Adult Intensive Care Units - ON TRACH

Acronym: ON TRACH

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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