Condition category
Surgery
Date applied
26/08/2014
Date assigned
07/10/2014
Last edited
31/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Background and study aims
Laryngoscopes are commonly used to help place a tube into a patient’s windpipe (a nasotracheal tube) after they have gone to sleep so that the anaesthetist can protect the airway and keep them safe during their procedure. Sometimes when the anaesthetist introduces the tube it needs to be directed with additional help by a pair of blunt forceps placed into the mouth to hold the tube and place it in the right position. These forceps are regularly used items (Magill’s forceps). We believe that using one laryngoscope called the McGrath Video laryngoscope in preference to the Macintosh laryngoscope may reduce the chances of having to use Magill’s forceps. This may reduce the chances of damage to teeth, sore throat and also the cost of the equipment, decreasing chances of complications and allowing savings to be diverted to other areas where patients will benefit.

Who can participate?
Patients whose operation requires that they have a nasotracheal tube placed into the windpipe will be asked to take part.

What does the study involve?
Patients will be brought to theatre as normal on the day of operation and into the anaesthetic room as normal. The anaesthetic procedure will be the same regardless of participation in the study. The only difference will be that the anaesthetist will be randomly allocated to use either the Macintosh laryngoscope or the McGrath Video laryngoscope. After the operation the anaesthetist will ask the patient if they have a sore throat - sore throat is a common side effect of anaesthesia and in general one in ten people will have a mild sore throat for a day or two after anaesthesia.

What are the possible benefits and risks of participating?
We do not believe that there will be any increased risk to those who take part in the study other than that normally associated with the surgery and anaesthetic.

Where is the study run from?
Institute of Neurological Science and Maxillofacial Surgery, Southern General Hospital, Glasgow, UK.

When is the study starting and how long is it expected to run for?
October 2014 to September 2015.

Who is funding the study?
1. The Department of Neuroanaesthetics Fund
2. Aircraft Medical (UK)

Who is the main contact?
Dr Simon P Young
spydoc@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simon P. Young

ORCID ID

Contact details

Department of Neuroanaesthetics
Institute of Neurological Sciences
Southern General Hospital
1345 Govan Road
Glasgow
G51 4TF
United Kingdom
+44 (0) 141 201 1989
spydoc@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised comparative trial of MacIntosh direct laryngoscopy versus the McGrath® MAC videolaryngoscope

Acronym

Study hypothesis

Nasotracheal intubation is employed extensively for oromaxillofacial surgery (OMFS) procedures involving the mandible and intra-oral pathology. Prolonged or repeated attempts, particularly when associated with use of intra-airway adjuncts to aid intubation, can be associated with adverse outcomes. Videolaryngoscopes (VL) could potentially lend themselves well to correct first-time, adjunct-free placement of nasally introduced tracheal tubes (TT), particularly when mouth opening may be limited and the airway may be soiled with blood.

Ethics approval

Research and Development Management Office; NHS Greater Glasgow and Clyde - approval pending

Study design

Prospective single-blind randomised comparative trial of the McGrath® MAC VL versus a standard Macintosh DL to intubate the trachea via the nasal route in OMFS patients

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

Oromaxillofacial surgery (OMFS) procedures involving the mandible and intra-oral pathology, requiring nasotracheal intubation: primarily trauma, also abscesses and tumours

Intervention

Patients presenting with OMFS trauma will form the bulk of the research population. By necessity these patients may be taken to theatre on the day of admission – we would therefore anticipate waiving the normal 24-hour ‘time to consider participation’ option. A patient information sheet (PIS), patient interview with a GCP-trained clinical researcher, and consent form (CF) will be delivered to each patient participant. They will be given at least two hours to consider their participation in the study.

The Sealed Envelope website will be used to generate a randomisation sequence for the study. Patients will be randomised to two groups: one to undergo nasotracheal intubation by MacIntosh direct laryngoscopy (DL), the other to undergo nasotracheal intubation by McGrath MAC videolaryngoscopy (VL).

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Use of the McGill’s forceps as an aid to intubation – this is used as a surrogate for difficulty in positioning the tracheal tube, and subsequent airway tissue trauma. This will be known immediately by the laryngoscopist.

Secondary outcome measures

1. Number of attempts at laryngoscopy
2. Number of attempts at tracheal tube passage
3. Failures/cross-overs to McGrath® MAC or other rescue technique, including patient wake-up
4. Cormack Lehane classification (CLC) and percentage of glottic opening (POGO)
5. Ease of TT insertion/any ‘hold-up’
6. Dental trauma requiring OMFS referral
7. Airway soft tissue (soft palate/tonsillar pillars) requiring ENT/OMFS referral
These secondary outcome measures will all be known immediately, again by the laryngoscopist.
8. Incidence of sore throat. will be known after the patient's operation, either from questioning in the recovery room, or later on the ward. In all cases, this will be known within 24 hours.

Overall trial start date

01/10/2014

Overall trial end date

30/09/2015

Reason abandoned

Insufficient clinical time.

Eligibility

Participant inclusion criteria

1. Adults with capacity undergoing general anaesthesia
2. Nasotracheal intubation planned, as agreed by both the anaesthetist and surgeon involved in the patient’s care, with administration of a neuromuscular blocking drug prior to intubation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

110

Participant exclusion criteria

1. Planned fibreoptic intubation or surgical airway
2. Manual inline stabilization required, or an external cervical fixation device (e.g. Halo)

Recruitment start date

01/10/2014

Recruitment end date

30/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Neuroanaesthetics
Glasgow
G51 4TF
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde (UK)

Sponsor details

c/o Dr Michael Barber
Research and Development Management Office
Western Infirmary
38 Church Street
Glasgow
G11 6NT
United Kingdom
+44 (0) 141 211 6208
Michael.Barber@ggc.scot.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

NHS Greater Glasgow and Clyde (UK) - Department of Neuroanaesthetics Fund (ref no: NEUROGAS001)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Aircraft Medical (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

Publication citations

Additional files

Editorial Notes

31/08/2016: This trial has been abandoned due to insufficient clinical time.