NCT02934347

Brief Summary

Our hypothesis is that the view of the glottis may be improved by putting all patients requiring intubation in the ramped or back up position while maintaining the classic sniffing position.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
781

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

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 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
5 months until next milestone

Results Posted

Study results publicly available

March 30, 2017

Completed
Last Updated

May 11, 2017

Status Verified

April 1, 2017

Enrollment Period

2.8 years

First QC Date

October 13, 2016

Results QC Date

October 17, 2016

Last Update Submit

April 5, 2017

Conditions

Keywords

Intubation, Back-up position; Glottis, View

Outcome Measures

Primary Outcomes (1)

  • The Best Glottic View Obtained During Laryngoscopy

    The best glottic view obtained during laryngoscopy was assessed using the Cormack and Lehane classification by the anaesthetist performing the laryngoscopy. The Cormack and Lehane classifies glottic views as follows: Grade 1: Most of the glottis is visible, Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen., Grade 3: Only the epiglottis is visible, Grade 4: No laryngeal structures are visible.

    The view of the glottis was measured once while the patient was being intubated

Secondary Outcomes (3)

  • The Number of Attempts at Both Laryngoscopy and Tracheal Intubation

    Once at intubation

  • The Use of Ancillary Equipment

    Once at intubation

  • The Time Between the Beginning of Laryngoscopy and Detection of Carbon Dioxide on the End-tidal Carbon Dioxide Monitor

    Once at intubation

Study Arms (2)

Supine

A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.

Back-up

A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips

Procedure: 25 degree back-up position

Interventions

To test whether a 25 degree back-up position improves laryngeal views and makes intubation easier compared to the standard horizontal position

Back-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who required intubation as part of their routine anaesthesia

You may qualify if:

  • Adult surgical patients who required intubation as part of their routine anaesthesia

You may not qualify if:

  • Patients less than 18 years old,
  • Patients recognised to have difficult airways where an alternative method of intubation (e.g. fibre optic) was the method of choice,
  • Patients undergoing emergency surgery where patient positioning and data collection might cause delay (e.g. exsanguinating patients) or where the supine position is not optimal (e.g. brisk bleeding into the upper airway),
  • Patients requiring rapid sequence induction of anaesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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
  • Bannister FB, Macbeth RG. Direct laryngoscopy and tracheal intubation. Lancet 1944; 2: 651-4

    BACKGROUND
  • 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
  • Jackson C. Bronchoscopy and Esophagoscopy: A Manual of Peroral Endoscopy and Laryngeal Surgery. Philadelphia and London: WB Saunders; 1922

    BACKGROUND
  • Lee BJ, Kang JM, Kim DO. Laryngeal exposure during laryngoscopy is better in the 25 degrees back-up position than in the supine position. Br J Anaesth. 2007 Oct;99(4):581-6. doi: 10.1093/bja/aem095. Epub 2007 Jul 4.

    PMID: 17611252BACKGROUND
  • Lee HC, Yun MJ, Hwang JW, Na HS, Kim DH, Park JY. Higher operating tables provide better laryngeal views for tracheal intubation. Br J Anaesth. 2014 Apr;112(4):749-55. doi: 10.1093/bja/aet428. Epub 2013 Dec 18.

    PMID: 24355831BACKGROUND
  • Rao SL, Kunselman AR, Schuler HG, DesHarnais S. Laryngoscopy and tracheal intubation in the head-elevated position in obese patients: a randomized, controlled, equivalence trial. Anesth Analg. 2008 Dec;107(6):1912-8. doi: 10.1213/ane.0b013e31818556ed.

    PMID: 19020138BACKGROUND
  • 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.

    PMID: 15527629BACKGROUND
  • Lane S, Saunders D, Schofield A, Padmanabhan R, Hildreth A, Laws D. A prospective, randomised controlled trial comparing the efficacy of pre-oxygenation in the 20 degrees head-up vs supine position. Anaesthesia. 2005 Nov;60(11):1064-7. doi: 10.1111/j.1365-2044.2005.04374.x.

    PMID: 16229689BACKGROUND
  • Dixon BJ, Dixon JB, Carden JR, Burn AJ, Schachter LM, Playfair JM, Laurie CP, O'Brien PE. Preoxygenation is more effective in the 25 degrees head-up position than in the supine position in severely obese patients: a randomized controlled study. Anesthesiology. 2005 Jun;102(6):1110-5; discussion 5A. doi: 10.1097/00000542-200506000-00009.

    PMID: 15915022BACKGROUND
  • Lebowitz PW, Shay H, Straker T, Rubin D, Bodner S. Shoulder and head elevation improves laryngoscopic view for tracheal intubation in nonobese as well as obese individuals. J Clin Anesth. 2012 Mar;24(2):104-8. doi: 10.1016/j.jclinane.2011.06.015. Epub 2012 Feb 1.

    PMID: 22301204BACKGROUND
  • Reddy RM, Adke M, Patil P, Kosheleva I, Ridley S; Anaesthetic Department at Glan Clwyd Hospital. Comparison of glottic views and intubation times in the supine and 25 degree back-up positions. BMC Anesthesiol. 2016 Nov 16;16(1):113. doi: 10.1186/s12871-016-0280-4.

Limitations and Caveats

The present study was under-powered to detect small differences in glottic views. There would be additional variation as the results were reported by the whole Anaesthetic Dept rather than a few investigators

Results Point of Contact

Title
Dr Raj Reddy
Organization
Glan Clwyd Hospital, Betsi Cadwaladr University Health Board

Study Officials

  • Raj M Reddy, FRCA

    Anaesthetic Department, Glan Clwyd Hospital, Betsi Cadwaladr University Health Board

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anaesthetist

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 17, 2016

Study Start

February 1, 2012

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

May 11, 2017

Results First Posted

March 30, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Publish anonymised raw data as supplementary file