Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
21/07/2009
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 Alexander Marfin

ORCID ID

Contact details

Department of Anaesthetics
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0176140630

Study information

Scientific title

Acronym

Study hypothesis

The laryngeal Tube (LT) is used in anaesthetics to secure patients' breathing and to administer oxygen and anaesthetic gases. LT consists of an airway tube with a small cuff attached at the tip (distal cuff) and a larger cuff at the middle part of the tube (proximal cuff). LT is inserted through the mouth. The proximal cuff provides a seal by forming a plug just above the voice box (larynx) and the distal cuff seals the gullet (oesophagus) inlet. There is a hole in the tube between the two cuffs to supply oxygen and anaesthetic gases through it. LT has a role in the airway management during anaesthesia and cardiopulmonary resuscitation. In patients with injury to the neck ("unstable necks"), airway management may be required while the head and neck are stabilised with the anaesthetist' assistant holding them in neutral position ("manual in-line sabilisation"). It is possible that this may make placement of the device more difficult. We wish to determine if the manual in-line stabilisation of the head and neck would alter the ease of insertion.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Surgery: Anaesthesia

Intervention

Randomised controlled trial. Comparison of 2 different insertion positions

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Clinically assessed adequacy of the ventilation via LT inserted in two different positions.

Secondary outcome measures

Ease and time of insertion of LT

Overall trial start date

01/05/2003

Overall trial end date

30/04/2004

Reason abandoned

Eligibility

Participant inclusion criteria

55 patients

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/05/2003

Recruitment end date

30/04/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Anaesthetics
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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

Hospital/treatment centre

Funder name

Oxford Radcliffe Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Not available

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

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15549973

Publication citations

  1. Results

    Asai T, Marfin AG, Thompson J, Popat M, Shingu K, Ease of insertion of the laryngeal tube during manual-in-line neck stabilisation., Anaesthesia, 2004, 59, 12, 1163-1166, doi: 10.1111/j.1365-2044.2004.03904.x.

Additional files

Editorial Notes