The McGrath® MAC videolaryngoscope for nasal intubation

ISRCTN ISRCTN34736271
DOI https://doi.org/10.1186/ISRCTN34736271
Secondary identifying numbers N/A
Submission date
26/08/2014
Registration date
07/10/2014
Last edited
31/08/2016
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Simon P. Young
Scientific

Department of Neuroanaesthetics
Institute of Neurological Sciences
Southern General Hospital
1345 Govan Road
Glasgow
G51 4TF
United Kingdom

Phone +44 (0) 141 201 1989
Email spydoc@gmail.com

Study information

Study designProspective 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 designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised comparative trial of MacIntosh direct laryngoscopy versus the McGrath® MAC videolaryngoscope
Study objectivesNasotracheal 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(s)Research and Development Management Office; NHS Greater Glasgow and Clyde - approval pending
Health condition(s) or problem(s) studiedOromaxillofacial surgery (OMFS) procedures involving the mandible and intra-oral pathology, requiring nasotracheal intubation: primarily trauma, also abscesses and tumours
InterventionPatients 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 typeProcedure/Surgery
Primary outcome measureUse 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 measures1. 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 study start date01/10/2014
Completion date30/09/2015
Reason abandoned (if study stopped)Insufficient clinical time.

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants110
Key inclusion criteria1. 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
Key exclusion criteria1. Planned fibreoptic intubation or surgical airway
2. Manual inline stabilization required, or an external cervical fixation device (e.g. Halo)
Date of first enrolment01/10/2014
Date of final enrolment30/09/2015

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Department of Neuroanaesthetics
Glasgow
G51 4TF
United Kingdom

Sponsor information

NHS Greater Glasgow and Clyde (UK)
Hospital/treatment centre

c/o Dr Michael Barber
Research and Development Management Office
Western Infirmary
38 Church Street
Glasgow
G11 6NT
Scotland
United Kingdom

Phone +44 (0) 141 211 6208
Email Michael.Barber@ggc.scot.nhs.uk
ROR logo "ROR" https://ror.org/05kdz4d87

Funders

Funder type

Hospital/treatment centre

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

No information available

Aircraft Medical (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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