- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02558036
Optimal Head and Neck Position During Videolaryngoscopy
Optimal Head and Neck Position for Intubation During Videolaryngoscopy: Comparison Between "Sniffing" and Neutral Position Using Channelled and Non-channelled Videolaryngoscopes
Study Overview
Status
Conditions
Detailed Description
The optimum patient head and neck position for direct laryngoscopy (when the anaesthetist views the larynx with a curved metallic blade before passing a tube for ventilation of the lungs) is traditionally considered to be the "sniffing the morning air" (neck flexion and head extension) position. This has been questioned previously as there is no randomized controlled study to date to explore this statement. The patient should be optimally positioned prior to induction of anaesthesia, especially because in the event of an unexpected difficult intubation, the Difficult Airway Society guidelines suggest the use of an alternative laryngoscope. In current clinical practice a videolaryngoscope (a curved blade with a camera attached to it that allows the anaesthetist to see around corners) has been used as an alternative laryngoscope. To the best of our knowledge, the ideal patient position for videolaryngoscopy has not yet been described. The intubation time and rate of success at intubation using a C-Mac D-Blade videolaryngoscope was previously assessed by Serocki et al, but only in the sniffing position. It is possible that adopting a different position when using the C-Mac D- Blade might result in a superior view of the larynx. Furthermore, the optimal patient position has not yet been assessed for intubation with the King Vision videolaryngoscope.
This key information could gain precious seconds in a difficult airway scenario (when securing the airway with a tube for ventilation proves difficult) and has obvious implications for patient management. The answer to this question could also help the anaesthetists take informed decisions when using videolaryngoscopy to intubate the trachea in elective settings. The investigators aim to assess the effect of two different positions on the laryngeal view obtained during videolaryngoscopy with two commercially available and well established videolaryngoscopes to try and answer this question.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Coventry, United Kingdom, CV2 2DX
- University Hospitals Coventry & Warwickshire NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients aged 18 and above, presenting for elective surgical procedure and requiring tracheal intubation will be invited to take part in the study.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: C-Mac D-Blade Neutral Position
C-Mac D-Blade videolaryngoscope with patients head and neck in neutral position.
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Using C-Mac D-Blade Videolaryngoscope patients will be positioned the neutral Head and Neck Position
Using C-Mac D-Blade Videolaryngoscope patients will be positioned in Sniffing Head and Neck Position
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Active Comparator: C-Mac D-Blade Sniffing Position
C-Mac D-Blade videolaryngoscope with patients head and neck in sniffing position.
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Using C-Mac D-Blade Videolaryngoscope patients will be positioned the neutral Head and Neck Position
Using C-Mac D-Blade Videolaryngoscope patients will be positioned in Sniffing Head and Neck Position
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Active Comparator: King Vision Neutral Position
King Vision videolaryngoscope with patients head and neck in neutral position.
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Using the King Vision Videolaryngoscope patients will be positioned in the neutral Head and Neck Position
Using the King Vision Videolaryngoscope patients will be positioned in Sniffing Head and Neck Position
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Active Comparator: King Vision Sniffing Position
King Vision videolaryngoscope with patients head and neck in sniffing position.
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Using the King Vision Videolaryngoscope patients will be positioned in the neutral Head and Neck Position
Using the King Vision Videolaryngoscope patients will be positioned in Sniffing Head and Neck Position
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optimal Head and Neck Position during Videolaryngoscopy
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Laryngoscopy Time
Time Frame: Less than 1 minute
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From when the laryngoscope enters the mouth until achieving the best view of the larynx.
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Less than 1 minute
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Intubation Time
Time Frame: Less than 1 minute
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from entering the mouth with the videolaryngoscope until endotracheal tube is inserted in the wind-pipe and the capnography trace is first visible on the screen.
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Less than 1 minute
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Collaborators and Investigators
Investigators
- Principal Investigator: Cyprian Mendonca, consultant
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 178075
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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