NCT05002790

Brief Summary

The traditional method of tracheal intubation requires the insertion of a laryngoscope into the oral cavity and directly visualisation of the glottis. The traditional head position called the sniffing the morning air position; consisting of lower cervical flexion and extension of the atlanto-occipital joint is commonly used to facilitate tracheal intubation in this manner by aligning the oral axes and providing the operator a view of the glottis. With the advancement of technology, has seen videolaryngoscopes (VL) developed to ease tracheal intubation. With VL, the glottis is seen through a camera connected to a viewing screen either attached to the top of the laryngoscope or connected to a camera screen by cable. One of the main drawbacks with VL is that a good view of the glottis is seen on the screen, but it can be difficult to pass the tracheal tube through the glottis in comparison to the traditional intubation technique described above. One of the main factors the authors suggest is that VL-assisted intubation requires a head and neck position that is different to the sniffing the morning air position. This study aims to assess the oral axes in three different head and neck positions under MRI to assess which positions improve axial alignment the most.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

August 5, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2021

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

August 28, 2024

Completed
Last Updated

August 28, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

August 4, 2021

Results QC Date

May 31, 2023

Last Update Submit

August 23, 2024

Conditions

Keywords

Airway managementVideolaryngoscopyHyperangulated blades

Outcome Measures

Primary Outcomes (1)

  • Angle A Measured on MRI

    To determine which patient head and neck positioning significantly improves the angle A. It is defined as the angle between the tracheal axis (TA) and laryngeal axis (LA)

    Each subject will undergo 3 MRI scans. Angle A will be measured on each scan at the end of all the scans performed that day. The angles will be measured by 2 investigators.

Secondary Outcomes (1)

  • Angle B, C, D and E Measured Using MRI

    Each subject will undergo 3 MRI scans. The angles will be measured on each scan at the end of the scanning performed that day. The angles will be measured by 2 investigators.

Study Arms (1)

Data collection

EXPERIMENTAL

All 20 anticipated subjects to be scanned under MRI, with data collected and analysed together

Diagnostic Test: Data collection group

Interventions

Data collection groupDIAGNOSTIC_TEST

Magnetic resonance imaging (MRI) allows measurement of the axes described to suggest which head and neck position would provide best anatomical alignment to reduce anterior impingement. All the MRI scans will be conducted using 3.0 Tesla (Optima 750w, GE Medical, Milwaukee, WI, USA) using the cervical spine section of the coil. T2-weighted images in the sagittal plane will be acquired using a fast recovery fast spin echo (FRFSE) technique. The scans will take around two and half minutes and a member of the anaesthetic investigator team will be present to facilitate positional changes and maintain consistency. MRI scanning will be performed in following 3 head and neck positions: Neutral position, Sniffing position and the Extension position.

Data collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to provide consent
  • Volunteers, UHCW staff, aged \> 18 years
  • Medically able and willing undertake MRI scanning.
  • Should pass the MRI safety check list to enter the MRI suite. All participants will complete an MR safety questionnaire immediately prior to their MR scan

You may not qualify if:

  • Unable to provide consent
  • Not willing to have MRI scan or unable to undergo MRI scanning
  • Known difficult intubation, Restricted or neck extension not possible or presence of arthritis of cervical spine.
  • For MRI safety reasons all participants with a cardiac pacemaker or other electronic implants will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

Related Publications (14)

  • Abramson ZR, Susarla S, Tagoni JR, Kaban L. Three-dimensional computed tomographic analysis of airway anatomy. J Oral Maxillofac Surg. 2010 Feb;68(2):363-71. doi: 10.1016/j.joms.2009.09.086. Epub 2010 Jan 15.

    PMID: 20116709BACKGROUND
  • Adnet F, Borron SW, Dumas JL, Lapostolle F, Cupa M, Lapandry C. Study of the "sniffing position" by magnetic resonance imaging. Anesthesiology. 2001 Jan;94(1):83-6. doi: 10.1097/00000542-200101000-00017.

    PMID: 11135726BACKGROUND
  • Adnet F, Baillard C, Borron SW, Denantes C, Lefebvre L, Galinski M, Martinez C, Cupa M, Lapostolle F. Randomized study comparing the "sniffing position" with simple head extension for laryngoscopic view in elective surgery patients. Anesthesiology. 2001 Oct;95(4):836-41. doi: 10.1097/00000542-200110000-00009.

    PMID: 11605921BACKGROUND
  • Aziz MF, Bayman EO, Van Tienderen MM, Todd MM; StAGE Investigator Group; Brambrink AM. Predictors of difficult videolaryngoscopy with GlideScope(R) or C-MAC(R) with D-blade: secondary analysis from a large comparative videolaryngoscopy trial. Br J Anaesth. 2016 Jul;117(1):118-23. doi: 10.1093/bja/aew128.

    PMID: 27317711BACKGROUND
  • Brindley PG, Simmonds MR, Needham CJ, Simmonds KA. Teaching airway management to novices: a simulator manikin study comparing the 'sniffing position' and 'win with the chin' analogies. Br J Anaesth. 2010 Apr;104(4):496-500. doi: 10.1093/bja/aeq020. Epub 2010 Feb 18.

    PMID: 20167582BACKGROUND
  • Cooper RM, Pacey JA, Bishop MJ, McCluskey SA. Early clinical experience with a new videolaryngoscope (GlideScope) in 728 patients. Can J Anaesth. 2005 Feb;52(2):191-8. doi: 10.1007/BF03027728.

    PMID: 15684262BACKGROUND
  • El-Orbany M, Woehlck H, Salem MR. Head and neck position for direct laryngoscopy. Anesth Analg. 2011 Jul;113(1):103-9. doi: 10.1213/ANE.0b013e31821c7e9c. Epub 2011 May 19.

    PMID: 21596871BACKGROUND
  • Horton WA, Fahy L, Charters P. Defining a standard intubating position using "angle finder". Br J Anaesth. 1989 Jan;62(1):6-12. doi: 10.1093/bja/62.1.6.

    PMID: 2917111BACKGROUND
  • Greenland KB, Edwards MJ, Hutton NJ. External auditory meatus-sternal notch relationship in adults in the sniffing position: a magnetic resonance imaging study. Br J Anaesth. 2010 Feb;104(2):268-9. doi: 10.1093/bja/aep390. No abstract available.

    PMID: 20086071BACKGROUND
  • Greenland KB, Edwards MJ, Hutton NJ, Challis VJ, Irwin MG, Sleigh JW. Changes in airway configuration with different head and neck positions using magnetic resonance imaging of normal airways: a new concept with possible clinical applications. Br J Anaesth. 2010 Nov;105(5):683-90. doi: 10.1093/bja/aeq239. Epub 2010 Sep 15.

    PMID: 20846964BACKGROUND
  • Levitan RM, Heitz JW, Sweeney M, Cooper RM. The complexities of tracheal intubation with direct laryngoscopy and alternative intubation devices. Ann Emerg Med. 2011 Mar;57(3):240-7. doi: 10.1016/j.annemergmed.2010.05.035. Epub 2010 Jul 31.

    PMID: 20674088BACKGROUND
  • Meisami T, Musa M, Keller MA, Cooper R, Clokie CM, Sandor GK. Magnetic resonance imaging assessment of airway status after orthognathic surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Apr;103(4):458-63. doi: 10.1016/j.tripleo.2006.07.006. Epub 2006 Oct 27.

    PMID: 17395062BACKGROUND
  • Mendonca C, Ungureanu N, Nowicka A, Kumar P. A randomised clinical trial comparing the 'sniffing' and neutral position using channelled (KingVision(R) ) and non-channelled (C-MAC(R) ) videolaryngoscopes. Anaesthesia. 2018 Jul;73(7):847-855. doi: 10.1111/anae.14289. Epub 2018 Apr 16.

    PMID: 29660807BACKGROUND
  • Stuck BA, Kopke J, Maurer JT, Verse T, Kuciak G, Duber C, Hormann K. Evaluating the upper airway with standardized magnetic resonance imaging. Laryngoscope. 2002 Mar;112(3):552-8. doi: 10.1097/00005537-200203000-00026.

    PMID: 12148870BACKGROUND

Results Point of Contact

Title
Cyprian Mendonca
Organization
University Hospitals Coventry &Watwickshire NHS Trust

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Single group assignment Controlled trial without randomisation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 12, 2021

Study Start

August 5, 2021

Primary Completion

October 21, 2021

Study Completion

October 21, 2021

Last Updated

August 28, 2024

Results First Posted

August 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations