Tracheostomy Management in Critical Care

ISRCTN	ISRCTN28588190
DOI	https://doi.org/10.1186/ISRCTN28588190
Protocol serial number	MRC ref: G0500970; 04/MRE00/43
Sponsor	Oxford Radcliffe Hospitals NHS Trust (UK)
Funders	The Intensive Care Society (UK) - funded the trial from 2004 to end of March 2006, Medical Research Council (UK) (ref: G0500970) - funded the trial from 1st April 2006 until completion of the trial

Submission date: 25/11/2004
Registration date: 01/12/2004
Last edited: 10/06/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Duncan Young
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Multi-centre
Study type	Participant information sheet
Scientific title	Tracheostomy Management in Critical Care: a randomised controlled trial
Study acronym	TracMan
Study objectives	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(s)	Scotland MREC A & Southampton and South West Hampshire REC A, approved in August 2004 (ref: 04/MRE00/43).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Mortality 30 days after randomisation.
Key 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
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1208
Key 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
Key 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
Date of first enrolment	01/10/2004
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

c/o Lesley Morgan

Oxford
OX3 9DU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/05/2013		Yes	No
Results article	propensity score matched cohort study results	01/06/2020	10/06/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/06/2020: Publication reference added.