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Tracheostomy Management in Critical Care
ISRCTN ISRCTN28588190
DOI 10.1186/ISRCTN28588190
ClinicalTrials.gov identifier
EudraCT number
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 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23695482
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 23/05/2013
Date ISRCTN assigned 01/12/2004
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