Condition category
Surgery
Date applied
09/11/2009
Date assigned
17/11/2009
Last edited
12/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Grant Price

ORCID ID

Contact details

Department of Anaesthetics
St John's Hospital
Livingston
EH54 6PP
United Kingdom
-
grant.price@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09/MRE00/54

Study information

Scientific title

A prospective randomised controlled trial of airway management in patients undergoing percutaneous tracheostomy and its effect on hypercarbia

Acronym

Study hypothesis

Maintenance of the airway during percutaneous tracheostomy with the laryngeal mask airway (LMA) Supreme™ supraglottic airway device, is at least as effective at maintaining mechanical ventilation as the use of a cuffed endotracheal tube.

Ethics approval

Scotland A Research Ethics Committee, 13/08/2009

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Percutaneous tracheostomy

Intervention

LMA Supreme™ versus cuffed oral endotracheal tube. Duration of intervention is variable but no more than 60 minutes. There is no follow up beyond the procedure itself.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Change in partial pressure of carbon dioxide in arterial blood (PaCO2) levels between start of percutaneous tracheostomy procedure and completion of tracheostomy procedure.

Secondary outcome measures

Measured during the procedure and immediately on completion of the procedure:
1. Combined complications (desaturation less than 92% during procedure, repositioning of airway device during procedure, loss of airway during procedure)
2. How many people required to help with airway maintenance
3. View on bronchoscopy of procedure
4. Time to airway ready
5. Total time from incision to tracheostomy placement

Overall trial start date

01/12/2009

Overall trial end date

01/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 18 years, either sex
2. Require a percutaneous tracheostomy as part of ongoing intensive care therapy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Aged less than 18 years
2. Patient or relative/welfare guardian refusal
3. Treating clinician refusal

Recruitment start date

01/12/2009

Recruitment end date

02/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St John's Hospital
Livingston
EH54 6PP
United Kingdom

Sponsor information

Organisation

NHS Lothian (UK)

Sponsor details

c/o Dr Tina McClelland
R&D Governance Manager
Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

Sponsor type

Government

Website

http://www.nhslothian.scot.nhs.uk/

Funders

Funder type

Government

Funder name

NHS Lothian (UK)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24803133

Publication citations

  1. Results

    Price GC, McLellan S, Paterson RL, Hay A, A prospective randomised controlled trial of the LMA Supreme vs cuffed tracheal tube as the airway device during percutaneous tracheostomy., Anaesthesia, 2014, 69, 7, 757-763, doi: 10.1111/anae.12595.

Additional files

Editorial Notes