NCT02885298

Brief Summary

Endotracheal intubation is most commonly taught and performed with the patient supine. Recent literature suggests that elevating the patient's head to a more upright position may decrease peri-intubation complications. However, there is little data on success rates of upright intubation in the emergency department. The goal of this study was to measure the association of head positioning with intubation success rates among emergency medicine residents.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

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

July 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

August 24, 2016

Last Update Submit

August 30, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • First Pass Success

    An attempt was defined as anytime the laryngoscope blade was placed in the patient's mouth. At the beginning of the study residents, faculty, and RTs were educated on this definition.

    Immediately at the time of the procedure

Secondary Outcomes (11)

  • overall success rate of orotracheal intubation overall success rate of orotracheal intubation overall success rate of intubation

    Immediately at the time of the procedure

  • Time required for successful intubation

    Immediately at the time of the procedure

  • esophageal intubation

    Immediately at the time of the procedure

  • cardiac arrest within 30 minutes of the intubation attempt

    cardiac arrest within 30 minutes of intubation

  • decrease in oxygen saturation during the procedure

    Immediately at the time of the procedure

  • +6 more secondary outcomes

Study Arms (3)

Supine intubations (0-10 degrees)

Intubations performed with patient positioned 0-10 degrees. Patient supine.

Procedure: Upright intubation

Inclined (11-44 degrees)

Intubations performed with 11-44 degrees of elevation.

Procedure: Upright intubation

Upright (45 degrees or greater)

intubations performed with patient elevated to 45 degrees or greater

Procedure: Upright intubation

Interventions

Upright Intubation procedure performed with patient elevated above the supine position. Defined as upright greater to or equal to 45 degrees or inclined 10-44 degrees

Inclined (11-44 degrees)Supine intubations (0-10 degrees)Upright (45 degrees or greater)

Eligibility Criteria

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

Intubation events that were eligible for enrollment included adult medical intubations performed at participating hospitals in which the intubating resident and supervising faculty both consented to study participation.

You may qualify if:

  • Adult medical intubations in which the intubating resident and supervising faculty both consented to study participation.

You may not qualify if:

  • Pediatric patients
  • Obstetric patients
  • Trauma patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (22)

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    PMID: 17999050BACKGROUND
  • Mouton WG, Bessell JR, Maddern GJ. Looking back to the advent of modern endoscopy: 150th birthday of Maximilian Nitze. World J Surg. 1998 Dec;22(12):1256-8. doi: 10.1007/s002689900555.

    PMID: 9841754BACKGROUND
  • Burkle CM, Zepeda FA, Bacon DR, Rose SH. A historical perspective on use of the laryngoscope as a tool in anesthesiology. Anesthesiology. 2004 Apr;100(4):1003-6. doi: 10.1097/00000542-200404000-00034. No abstract available.

    PMID: 15087639BACKGROUND
  • Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.

    PMID: 15271750BACKGROUND
  • Jaber S, Amraoui J, Lefrant JY, Arich C, Cohendy R, Landreau L, Calvet Y, Capdevila X, Mahamat A, Eledjam JJ. Clinical practice and risk factors for immediate complications of endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Crit Care Med. 2006 Sep;34(9):2355-61. doi: 10.1097/01.CCM.0000233879.58720.87.

    PMID: 16850003BACKGROUND
  • Li J, Murphy-Lavoie H, Bugas C, Martinez J, Preston C. Complications of emergency intubation with and without paralysis. Am J Emerg Med. 1999 Mar;17(2):141-3. doi: 10.1016/s0735-6757(99)90046-3.

    PMID: 10102312BACKGROUND
  • Schwartz DE, Matthay MA, Cohen NH. Death and other complications of emergency airway management in critically ill adults. A prospective investigation of 297 tracheal intubations. Anesthesiology. 1995 Feb;82(2):367-76. doi: 10.1097/00000542-199502000-00007.

    PMID: 7856895BACKGROUND
  • Mort TC. Complications of emergency tracheal intubation: hemodynamic alterations--part I. J Intensive Care Med. 2007 May-Jun;22(3):157-65. doi: 10.1177/0885066607299525.

    PMID: 17562739BACKGROUND
  • Mort TC. Complications of emergency tracheal intubation: immediate airway-related consequences: part II. J Intensive Care Med. 2007 Jul-Aug;22(4):208-15. doi: 10.1177/0885066607301359.

    PMID: 17712056BACKGROUND
  • Griesdale DE, Bosma TL, Kurth T, Isac G, Chittock DR. Complications of endotracheal intubation in the critically ill. Intensive Care Med. 2008 Oct;34(10):1835-42. doi: 10.1007/s00134-008-1205-6. Epub 2008 Jul 5.

    PMID: 18604519BACKGROUND
  • Dargin JM, Emlet LL, Guyette FX. The effect of body mass index on intubation success rates and complications during emergency airway management. Intern Emerg Med. 2013 Feb;8(1):75-82. doi: 10.1007/s11739-012-0874-x. Epub 2012 Nov 25.

    PMID: 23184440BACKGROUND
  • Jaber S, Jung B, Corne P, Sebbane M, Muller L, Chanques G, Verzilli D, Jonquet O, Eledjam JJ, Lefrant JY. An intervention to decrease complications related to endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Intensive Care Med. 2010 Feb;36(2):248-55. doi: 10.1007/s00134-009-1717-8. Epub 2009 Nov 17.

    PMID: 19921148BACKGROUND
  • Kim GW, Koh Y, Lim CM, Han M, An J, Hong SB. Does medical emergency team intervention reduce the prevalence of emergency endotracheal intubation complications? Yonsei Med J. 2014 Jan;55(1):92-8. doi: 10.3349/ymj.2014.55.1.92.

    PMID: 24339292BACKGROUND
  • Khandelwal N, Khorsand S, Mitchell SH, Joffe AM. Head-Elevated Patient Positioning Decreases Complications of Emergent Tracheal Intubation in the Ward and Intensive Care Unit. Anesth Analg. 2016 Apr;122(4):1101-7. doi: 10.1213/ANE.0000000000001184.

    PMID: 26866753BACKGROUND
  • 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
  • Ramkumar V, Umesh G, Philip FA. Preoxygenation with 20 masculine head-up tilt provides longer duration of non-hypoxic apnea than conventional preoxygenation in non-obese healthy adults. J Anesth. 2011 Apr;25(2):189-94. doi: 10.1007/s00540-011-1098-3. Epub 2011 Feb 4.

    PMID: 21293885BACKGROUND
  • 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
  • Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055.

    PMID: 23574475BACKGROUND
  • Diggs LA, Viswakula SD, Sheth-Chandra M, De Leo G. A pilot model for predicting the success of prehospital endotracheal intubation. Am J Emerg Med. 2015 Feb;33(2):202-8. doi: 10.1016/j.ajem.2014.11.020. Epub 2014 Nov 20.

    PMID: 25488339BACKGROUND
  • Neligan PJ, Porter S, Max B, Malhotra G, Greenblatt EP, Ochroch EA. Obstructive sleep apnea is not a risk factor for difficult intubation in morbidly obese patients. Anesth Analg. 2009 Oct;109(4):1182-6. doi: 10.1213/ane.0b013e3181b12a0c.

    PMID: 19762747BACKGROUND
  • Tremblay MH, Williams S, Robitaille A, Drolet P. Poor visualization during direct laryngoscopy and high upper lip bite test score are predictors of difficult intubation with the GlideScope videolaryngoscope. Anesth Analg. 2008 May;106(5):1495-500, table of contents. doi: 10.1213/ane.0b013e318168b38f.

    PMID: 18420866BACKGROUND

Study Officials

  • Joseph Turner, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Emergency Medicine

Study Record Dates

First Submitted

August 24, 2016

First Posted

August 31, 2016

Study Start

July 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 31, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access