Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MRC ref: G0500970; 04/MRE00/43
Study information
Scientific title
Tracheostomy Management in Critical Care: a randomised controlled trial
Acronym
TracMan
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.
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
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information can be found at: http://www.tracman.org.uk/
Condition
Tracheostomy
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Mortality 30 days after randomisation.
Secondary outcome measures
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
Overall trial start date
01/10/2004
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1,208
Participant 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
Recruitment start date
01/10/2004
Recruitment end date
31/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
c/o Lesley Morgan
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
Oxford Radcliffe Hospitals NHS Trust (UK)
Sponsor details
Research and Development Office
Manor House
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
The Intensive Care Society (UK) - funded the trial from 2004 to end of March 2006
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Medical Research Council (UK) (ref: G0500970) - funded the trial from 1st April 2006 until completion of the trial
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23695482
Publication citations
-
Results
Young D, Harrison DA, Cuthbertson BH, Rowan K, , Effect of early vs late tracheostomy placement on survival in patients receiving mechanical ventilation: the TracMan randomized trial., JAMA, 2013, 309, 20, 2121-2129, doi: 10.1001/jama.2013.5154.