Condition category
Respiratory
Date applied
25/11/2004
Date assigned
01/12/2004
Last edited
23/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.tracman.org.uk/

Contact information

Type

Scientific

Primary contact

Dr Duncan Young

ORCID ID

Contact details

c/o Lesley Morgan
Kadoorie Centre for Critical Care Research and Education
Level 3
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

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 measures

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

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

http://www.oxfordradcliffe.nhs.uk

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

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23695482

Publication citations

  1. 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.

Additional files

Editorial Notes