Comparison of two airway devices to aid breathing during percutaneous tracheostomy

ISRCTN	ISRCTN23203142
DOI	https://doi.org/10.1186/ISRCTN23203142
Protocol serial number	09/MRE00/54
Sponsor	NHS Lothian (UK)
Funder	NHS Lothian (UK)

Submission date: 09/11/2009
Registration date: 17/11/2009
Last edited: 12/06/2015

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Grant Price
Scientific

Department of Anaesthetics
St John's Hospital
Livingston
EH54 6PP
United Kingdom

Email	grant.price@nhs.net

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A prospective randomised controlled trial of airway management in patients undergoing percutaneous tracheostomy and its effect on hypercarbia
Study objectives	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(s)	Scotland A Research Ethics Committee, 13/08/2009
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Change in partial pressure of carbon dioxide in arterial blood (PaCO2) levels between start of percutaneous tracheostomy procedure and completion of tracheostomy procedure.
Key secondary outcome measure(s)	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
Completion date	01/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. Aged over 18 years, either sex 2. Require a percutaneous tracheostomy as part of ongoing intensive care therapy
Key exclusion criteria	1. Aged less than 18 years 2. Patient or relative/welfare guardian refusal 3. Treating clinician refusal
Date of first enrolment	01/12/2009
Date of final enrolment	02/09/2011

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

St John's Hospital

Livingston
EH54 6PP
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	01/07/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes