- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02885298
Effect of Upright Patient Positioning on Intubation Success
August 30, 2016 updated by: Joseph Turner, Indiana University
Prospective Observational Study of the Effect of Upright Patient Positioning on Intubation Success Rates at Two Academic Emergency Departments
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 Overview
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.
Study Type
Observational
Enrollment (Actual)
232
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Supine intubations (0-10 degrees)
Intubations performed with patient positioned 0-10 degrees.
Patient supine.
|
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)
Intubations performed with 11-44 degrees of elevation.
|
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
|
|
Upright (45 degrees or greater)
intubations performed with patient elevated to 45 degrees or greater
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First Pass Success
Time Frame: Immediately at the time of the procedure
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
overall success rate of orotracheal intubation overall success rate of orotracheal intubation overall success rate of intubation
Time Frame: Immediately at the time of the procedure
|
endotracheal tube in place
|
Immediately at the time of the procedure
|
|
Time required for successful intubation
Time Frame: Immediately at the time of the procedure
|
endotracheal tube in place
|
Immediately at the time of the procedure
|
|
esophageal intubation
Time Frame: Immediately at the time of the procedure
|
endotracheal tube determined to be positioned in esophagus rather
|
Immediately at the time of the procedure
|
|
cardiac arrest within 30 minutes of the intubation attempt
Time Frame: cardiac arrest within 30 minutes of intubation
|
cardiac arrest within 30 minutes of intubation
|
|
|
decrease in oxygen saturation during the procedure
Time Frame: Immediately at the time of the procedure
|
Immediately at the time of the procedure
|
|
|
best Cormack-Lehane view
Time Frame: Immediately at the time of the procedure
|
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
|
|
best Percent of Glottic Opening (POGO)
Time Frame: obtained during the procedure
|
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
|
|
Resident Satisfaction with Positioning
Time Frame: following procedure
|
survey completed following the procedure by provider regarding satisfaction
|
following procedure
|
|
death in ED
Time Frame: While in the emergency department (1 hour up to 1 day)
|
While in the emergency department (1 hour up to 1 day)
|
|
|
death within 5 days of intubation
Time Frame: Death within 5 days following intubation
|
any cause of death within 5 days after intubation
|
Death within 5 days following intubation
|
|
New pneumonia
Time Frame: within 5 days following intubation
|
new pneumonia developed within 5 days following an intubation.
Not present on admission.
|
within 5 days following intubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph Turner, MD, Indiana University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
August 24, 2016
First Submitted That Met QC Criteria
August 30, 2016
First Posted (Estimate)
August 31, 2016
Study Record Updates
Last Update Posted (Estimate)
August 31, 2016
Last Update Submitted That Met QC Criteria
August 30, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 1405954059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Study Data/Documents
-
Study Protocol
Information comments: Study protocol can be provided via email if requested. Please email turnjose@iu.edu
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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