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11 February 2012
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| [ Print-friendly version ] |
| Tracheostomy Management in Critical Care |
| ISRCTN | ISRCTN28588190 |
| ClinicalTrials.gov identifier | |
| Public title | Tracheostomy Management in Critical Care |
| Scientific title | Tracheostomy Management in Critical Care: a randomised controlled trial |
| Acronym | TracMan |
| Serial number at source | MRC ref: G0500970; 04/MRE00/43 |
| Study hypothesis |
Patients with type 1 or type 2 respiratory failure requiring ventilation in the Intensive Care Unit (ICU). Investigating the best time to place a tracheostomy in such patients.
In patients predicted to require ventilatory support for 7 days or more, placing a tracheostomy on day 1 to 4 following ICU admission reduces mortality at day 30 (post randomisation) compared with a tracheostomy placed on or after day 10. Protocol can be found at: http://www.tracman.org.uk/ Please note that some information on this ISRCTN record have been amended as of 27/03/2009. The amendments include the following: 1. Scientific title was added 2. The anticipated end date has been updated from 31/12/2009 to 31/12/2008 Other changes are recorded in the relevant fields. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Scotland MREC A & Southampton and South West Hampshire REC A, approved in August 2004 (ref: 04/MRE00/43). |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Tracheostomy |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/10/2004 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Completed |
| Patient information material | Patient information can be found at: http://www.tracman.org.uk/ |
| Target number of participants | 1,208 |
| Interventions |
Group 1: 'Early tracheostomy'
Tracheostomy on day 1 to 4 post ICU admission Group 2: 'Late tracheostomy' No tracheostomy before day 10 post ICU admission |
| Primary outcome measure(s) | Mortality 30 days after randomisation. |
| Secondary outcome measure(s) |
1. Mortality rate at discharge from hospital
2. ICU length of stay 3. Hospital length of stay (acute hospitals) 4. Mortality rate at (first) discharge from ICU 5. Number of days receiving any sedative medication 6. Number of antibiotic-free days Added as of 27/03/2009: Mortality is followed up for 2 years post randomisation. All other secondary outcomes: data are collected whilst in intensive care, or up to hospital discharge |
| Sources of funding |
1. The Intensive Care Society (UK) - funded the trial from 2004 to end of March 2006
2. Medical Research Council (UK) (ref: G0500970) - funded the trial from 1st April 2006 until completion of the trial |
| Trial website | http://www.tracman.org.uk/ |
| Publications | |
| Contact name | Dr Duncan Young |
| Address |
c/o Lesley Morgan
Kadoorie Centre for Critical Care Research and Education Level 3 John Radcliffe Hospital |
| City/town | Oxford |
| Zip/Postcode | OX3 9DU |
| Country | United Kingdom |
| Sponsor | Oxford Radcliffe Hospitals NHS Trust (UK) |
| Address |
Research and Development Office
Manor House John Radcliffe Hospital |
| City/town | Oxford |
| Zip/Postcode | OX3 9DU |
| Country | United Kingdom |
| Sponsor website: | http://www.oxfordradcliffe.nhs.uk |
| Date applied | 25/11/2004 |
| Last edited | 14/11/2011 |
| Date ISRCTN assigned | 01/12/2004 |
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| © 2012 ISRCTN unless otherwise stated. | |
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