Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
28/10/2009
Prospective/Retrospective
Retrospectively 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 Mansukh T Popat

ORCID ID

Contact details

Anaesthetics Department
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
+44 01865 221590
mansukh.popat@nda.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0176179733

Study information

Scientific title

Acronym

Study hypothesis

The rate of successful insertion during routine clinical anaesthesia is the primary outcome measure for comparison between the two supraglottic airway devices. 'Successful insertion' is defined as the provision of both an unobstructed, patient airway as judged clinically and by the measurement of satisfactory leak pressure. Pressure is needed to ventilate the lungs. Above a certain normal pressure, there is an audible leak of gas from between the patient's larynx and the airway management device. This leak pressure is recorded routinely all anaesthetics. The better the seal of a device at the patient's larynx, the higher the leak pressure.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Anaesthesia

Intervention

1. Selection of research participants
2. Explanation of research proposal and procedure, including provision of written information sheet and sufficient time for questions
3. Written consent
4. Randomisation to receive either i-gel airway (I-gel group) or LMAu (LMA group)
5. Induction and maintenance of anesthesia in a standard manner
6. Insertion of selected airway device, examining study objectives (as above)
7. After successful insertion, it will be left in place for the maintenance of anaesthesia
8. After the end of the operation the patient will regain consciousness and the device will be removed
9. Routine assessment will be made of sore throat etc, as is normal practice

Intervention type

Device

Phase

Not Specified

Drug names

Primary outcome measures

Clinically successful placement of the device, ie 'successful insertion' and 'adequate leak pressure'.

Secondary outcome measures

Incidence of complications and post-operative presence of any subjective difficulty or pain with speaking, swallowing, jaw or neck movement, or any alteration to hearing or tongue sensation.

Overall trial start date

18/05/2006

Overall trial end date

18/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. ASA I or II patients (fit and healthy or with minor well-controlled chronic disease)
2. Age 16-70 years
3. Weight 30-120 kg
4. Not pregnant
5. Booked for elective surgery of duration <2 hours
6. Fasted
7. Normal airway assessment
8. Consenting

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300 patients

Participant exclusion criteria

1. Age <16 or >80, or weight <30 or >120kg
2. Pregnancy
3. Emergency surgery
4. Surgery > 2 hours duration
5. Patient not fit (ASA >=III)
6. Patient not starved
7. History of symptomatic reflux disease
8. History of difficult airway mgmt during previous anaesthesia
9. Anticipated difficult airway
10. Previous radiotherapy to head/neck
11. Heavy smokers >20 cigarettes/d
12. Non-consenting

Recruitment start date

18/05/2006

Recruitment end date

18/05/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anaesthetics Department
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Oxford Radcliffe Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19846406

Publication citations

  1. Results

    Uppal V, Gangaiah S, Fletcher G, Kinsella J, Randomized crossover comparison between the i-gel and the LMA-Unique in anaesthetized, paralysed adults., Br J Anaesth, 2009, 103, 6, 882-885, doi: 10.1093/bja/aep292.

Additional files

Editorial Notes