Tracheostomy Management in Critical Care

Not Applicable

Completed

• Conditions: Tracheostomy; Respiratory; Respiratory failure

• Registration Number: ISRCTN28588190
• Lead Sponsor: Oxford Radcliffe Hospitals NHS Trust (UK)

Brief Summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23695482 2. 2020 propensity score matched cohort study results in https://doi.org/10.1136/bmjopen-2020-037762 (added 10/06/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-12-01
• Study Completion: 2008-12-31
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1208

Inclusion Criteria

Eligible patients are those who
1. Are intubated
2. Have a high chance of requiring a further 7 days or more of ventilatory support during their ICU stay
3. Have been in the intensive care unit for less than 4 days
4. The recruiting consultant is uncertain about whether an 'early' or 'late' tracheostomy is more appropriate for this patient

Exclusion Criteria

The uncertainty principle can also be used to determine which patients are ineligible for the trial. However ethical approval requires explicit listing of excluded patients and vulnerable groups. The following patients must not be included in the trial:

Patients:
1. Not assessed on days 1-4 following ICU admission regarding their predicted requirement for at least a further 7 days of ventilatory support.
2. For whom an immediate tracheostomy is required to alleviate upper airway obstruction
3. With a tracheal stoma or tracheostomy tube in situ on admission to the ICU
4. With chronic hypercarbic (type 2) respiratory failure due to a chronic neurological disease
5. Less than 16 years of age
6. Previously enrolled in the TracMan trial during the same hospital admission
7. Refusing consent or patients in whom relatives refuse assent
8. Who were ?legally incompetent? prior to their hospital admission
9. Or their relatives who do not understand written or verbal information for whom an interpreter is not available

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality 30 days after randomisation.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Mortality rate at discharge from hospital<br> 2. ICU length of stay<br> 3. Hospital length of stay (acute hospitals)<br> 4. Mortality rate at (first) discharge from ICU<br> 5. Number of days receiving any sedative medication<br> 6. Number of antibiotic-free days<br><br> Added as of 27/03/2009:<br> Mortality is followed up for 2 years post randomisation.<br> All other secondary outcomes: data are collected whilst in intensive care, or up to hospital discharge<br>