Clinical trial NCT02885298: Effect of Upright Patient Positioning on Intubation Success
Official title: Prospective Observational Study of the Effect of Upright Patient Positioning on Intubation Success Rates at Two Academic Emergency Departments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: 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. Study design was a prospective observational study. Residents performing intubation recorded the angle of the head of the bed, and the number of attempts required for successful intubation was recorded by faculty and respiratory therapists. The primary outcome of first past success was calculated with respect to three groups: 0-10 degrees (supine), 11-44 degrees (inclined), and ≥45 degrees (upright); first past success was also analyzed in 5 degree angle increments.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pediatric patients
* Obstetric patients
* Trauma patients

Primary outcomes:
measure: First Pass Success
timeFrame: Immediately at the time of the procedure
Secondary outcomes:
measure: overall success rate of orotracheal intubation overall success rate of orotracheal intubation overall success rate of intubation
timeFrame: Immediately at the time of the procedure
measure: Time required for successful intubation
timeFrame: Immediately at the time of the procedure
measure: esophageal intubation
timeFrame: Immediately at the time of the procedure
measure: cardiac arrest within 30 minutes of the intubation attempt
timeFrame: cardiac arrest within 30 minutes of intubation
measure: decrease in oxygen saturation during the procedure
timeFrame: Immediately at the time of the procedure
measure: best Cormack-Lehane view
timeFrame: Immediately at the time of the procedure
measure: best Percent of Glottic Opening (POGO)
timeFrame: obtained during the procedure
measure: Resident Satisfaction with Positioning
timeFrame: following procedure
measure: death in ED
timeFrame: While in the emergency department (1 hour up to 1 day)
measure: death within 5 days of intubation
timeFrame: Death within 5 days following intubation
measure: New pneumonia
timeFrame: within 5 days following intubation
Other outcomes:
Locations:
Study officials:
affiliation: Indiana University
name: Joseph Turner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szmuk P, Ezri T, Evron S, Roth Y, Katz J. A brief history of tracheostomy and tracheal intubation, from the Bronze Age to the Space Age. Intensive Care Med. 2008 Feb;34(2):222-8. doi: 10.1007/s00134-007-0931-5. Epub 2007 Nov 13.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.