Intensive Care (ICU), Tracheostomy Decannulation, Tracheostomy Patients
Conditions
Keywords
tracheostomy, decannulation, intensive care, prolonged mechanical ventilation, tracheostomy weaning, tracheostomy outcomes
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.
Detailed description
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.
Interventions
None listed
Sponsors
Royal College of Surgeons, Ireland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful tracheostomy decannulation | 90 days | The proportion of patients successfully decannulated from tracheostomy, censored at hospital discharge or 90 days, whichever comes first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to decannulation | 90 days | Time to successful decannulation censored at hospital discharge or 90 days, whichever comes first. |
| Mortality | 90 days | — |
| Hospital utilization metrics | 90 days | Duration of mechanical ventilation, ICU and hospital length of stay |
| Return to vocalisation | 90 days | Measured by time in days to placement of a speaking valve |
| Return to oral intake | 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. |
| Return to mobilisation | 90 days | Measured using the Intensive Care Mobility Scale which ranges from 1 to 10 with 10 indicating a greater degree of mobility. |
| Health related quality of life | 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. |
Countries
Brazil, Canada, India, Ireland, Italy, Switzerland, United Kingdom, United States
Contacts
CONTACTAisling Mc Mahon, MB BCh BAO FCAI FJFICMI
CONTACTMichelle Smyth, BSc
Outcome results
None listed