Tracheostomy Management in Critical Care
| ISRCTN | ISRCTN28588190 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28588190 |
| Secondary identifying numbers | MRC ref: G0500970; 04/MRE00/43 |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.tracman.org.uk/ |
| 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 | 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 study start date | 01/10/2004 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1,208 |
| 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
- England
- United Kingdom
Study participating centre
c/o Lesley Morgan
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
Oxford Radcliffe Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Office
Manor House
John Radcliffe Hospital
Oxford
OX3 9DU
England
United Kingdom
| Website | http://www.oxfordradcliffe.nhs.uk |
|---|---|
"ROR" |
https://ror.org/03h2bh287 |
Funders
Funder type
Charity
The Intensive Care Society (UK) - funded the trial from 2004 to end of March 2006
No information available
Medical Research Council (UK) (ref: G0500970) - funded the trial from 1st April 2006 until completion of the trial
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
10/06/2020: Publication reference added.
