NCT02558036

Brief Summary

Optimal patient head and neck position when performing videolaryngoscopy for endotracheal intubation has not yet been established.The investigators aim to assess the effect of two different positions on the laryngeal view obtained and success of tracheal intubation during videolaryngoscopy with two commercially available and well established videolaryngoscopes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration 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

Study Start

First participant enrolled

February 11, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2017

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

2.2 years

First QC Date

September 22, 2015

Last Update Submit

August 6, 2018

Conditions

Keywords

Head Neck Position Videolaryngoscopy

Outcome Measures

Primary Outcomes (1)

  • Optimal Head and Neck Position during Videolaryngoscopy

    This will be assessed using a Difficult Intubation Scale Score for each of the 2 videolaryngoscopes used in the study, which will be assessed in both neutral and sniffing positions.

    6 months

Secondary Outcomes (2)

  • Laryngoscopy Time

    Less than 1 minute

  • Intubation Time

    Less than 1 minute

Study Arms (4)

C-Mac D-Blade Neutral Position

ACTIVE COMPARATOR

C-Mac D-Blade videolaryngoscope with patients head and neck in neutral position.

Other: C-Mac D-Blade Videolaryngoscope

C-Mac D-Blade Sniffing Position

ACTIVE COMPARATOR

C-Mac D-Blade videolaryngoscope with patients head and neck in sniffing position.

Other: C-Mac D-Blade Videolaryngoscope

King Vision Neutral Position

ACTIVE COMPARATOR

King Vision videolaryngoscope with patients head and neck in neutral position.

Other: King Vision Videolaryngoscope

King Vision Sniffing Position

ACTIVE COMPARATOR

King Vision videolaryngoscope with patients head and neck in sniffing position.

Other: King Vision Videolaryngoscope

Interventions

Using C-Mac D-Blade Videolaryngoscope patients will be positioned the neutral Head and Neck Position

C-Mac D-Blade Neutral Position

Using the King Vision Videolaryngoscope patients will be positioned in the neutral Head and Neck Position

King Vision Neutral Position

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients aged 18 and above, presenting for elective surgical procedure and requiring tracheal intubation will be invited to take part in the study.

You may not qualify if:

  • Patients who are refusing to take part, below 18 years of age, pregnant women, American society of anaesthesiologists' class 4 and above, those requiring rapid sequence indication, super morbidly obese (BMI \>50) and those patients requiring awake fibreoptic intubation will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

Location

Related Publications (8)

  • 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.

  • 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.

  • Serocki G, Neumann T, Scharf E, Dorges V, Cavus E. Indirect videolaryngoscopy with C-MAC D-Blade and GlideScope: a randomized, controlled comparison in patients with suspected difficult airways. Minerva Anestesiol. 2013 Feb;79(2):121-9. Epub 2012 Oct 2.

  • Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.

  • 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.

  • Collins JS, Lemmens HJ, Brodsky JB, Brock-Utne JG, Levitan RM. Laryngoscopy and morbid obesity: a comparison of the "sniff" and "ramped" positions. Obes Surg. 2004 Oct;14(9):1171-5. doi: 10.1381/0960892042386869.

  • Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.

  • Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013 Aug;68 Suppl 1:i1-i44. doi: 10.1136/thoraxjnl-2013-203618. No abstract available.

Study Officials

  • Cyprian Mendonca

    Consultant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2015

First Posted

September 23, 2015

Study Start

February 11, 2015

Primary Completion

April 27, 2017

Study Completion

April 27, 2017

Last Updated

August 8, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations