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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02885298
Other study ID # 1405954059
Secondary ID
Status Completed
Phase N/A
First received August 24, 2016
Last updated August 30, 2016
Start date July 2014
Est. completion date July 2016

Study information

Verified date August 2016
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 232
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Upright intubation
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

References & Publications (22)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2007 Jul 4. — View 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. — View Citation

Mort TC. Complications of emergency tracheal intubation: hemodynamic alterations--part I. J Intensive Care Med. 2007 May-Jun;22(3):157-65. Review. — View 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. Review. — View Citation

Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. — View 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. — View 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. — View Citation

Ramkumar V, Umesh G, Philip FA. Preoxygenation with 20º 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. — View 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. — View 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. — View 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. Epub 2007 Nov 13. — View 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. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary overall success rate of orotracheal intubation overall success rate of orotracheal intubation overall success rate of intubation endotracheal tube in place Immediately at the time of the procedure No
Secondary Time required for successful intubation endotracheal tube in place Immediately at the time of the procedure No
Secondary esophageal intubation endotracheal tube determined to be positioned in esophagus rather Immediately at the time of the procedure No
Secondary cardiac arrest within 30 minutes of the intubation attempt cardiac arrest within 30 minutes of intubation No
Secondary decrease in oxygen saturation during the procedure Immediately at the time of the procedure No
Secondary best Cormack-Lehane view Cormack-Lehane view is a scale that is used to describe the amount of vocal cords visualized during the procedure Immediately at the time of the procedure No
Secondary best Percent of Glottic Opening (POGO) Percent of glottis opening refers to the percentage of vocal cords and surrounding anatomy which can be seen during the procedure obtained during the procedure No
Secondary Resident Satisfaction with Positioning survey completed following the procedure by provider regarding satisfaction following procedure No
Secondary death in ED While in the emergency department (1 hour up to 1 day) No
Secondary death within 5 days of intubation any cause of death within 5 days after intubation Death within 5 days following intubation No
Secondary New pneumonia new pneumonia developed within 5 days following an intubation. Not present on admission. within 5 days following intubation No
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