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IntubationNCT02885298

Effect of Upright Patient Positioning on Intubation Success

An observational study of Intubation, run by Indiana University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intubation
What is being tested?
Upright intubation
Type of treatment
Surgery or procedure
How many people
232 participants
Where
No sites listed yet
Study dates
Jul 2014to Jul 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Pediatric patients
  • Obstetric patients
  • Trauma patients

About this study

Official title: 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.

Read the 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.

Conditions
Intubation
Being tested
Upright intubation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Upright intubationProcedure or surgery

    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

Study groups in NCT02885298
Study groupRoleWhat they receive
Supine intubations (0-10 degrees)Intubations performed with patient positioned 0-10 degrees. Patient supine.
Receives: Procedure: Upright intubation
Inclined (11-44 degrees)Intubations performed with 11-44 degrees of elevation.
Receives: Procedure: Upright intubation
Upright (45 degrees or greater)intubations performed with patient elevated to 45 degrees or greater
Receives: Procedure: Upright intubation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Immediately at the time of the procedure

Secondary outcomes (11)

  1. overall success rate of orotracheal intubation overall success rate of orotracheal intubation overall success rate of intubation

    endotracheal tube in place

    Measured: Immediately at the time of the procedure

  2. Time required for successful intubation

    endotracheal tube in place

    Measured: Immediately at the time of the procedure

  3. esophageal intubation

    endotracheal tube determined to be positioned in esophagus rather

    Measured: Immediately at the time of the procedure

  4. cardiac arrest within 30 minutes of the intubation attempt

    Measured: cardiac arrest within 30 minutes of intubation

  5. decrease in oxygen saturation during the procedure

    Measured: Immediately at the time of the procedure

  6. best Cormack-Lehane view

    Cormack-Lehane view is a scale that is used to describe the amount of vocal cords visualized during the procedure

    Measured: Immediately at the time of the procedure

  7. 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

    Measured: obtained during the procedure

  8. Resident Satisfaction with Positioning

    survey completed following the procedure by provider regarding satisfaction

    Measured: following procedure

  9. death in ED

    Measured: While in the emergency department (1 hour up to 1 day)

  10. death within 5 days of intubation

    any cause of death within 5 days after intubation

    Measured: Death within 5 days following intubation

  11. New pneumonia

    new pneumonia developed within 5 days following an intubation. Not present on admission.

    Measured: within 5 days following intubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2016 (estimated)
  2. Study startJul 2014
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
232 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02885298
Sponsor's protocol ID
1405954059
Status last verified
Aug 2016
First submitted
24 Aug 2016
Last updated
31 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17999050

  • 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.

    PubMed 9841754

  • 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.

    PubMed 15087639

  • 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.

    PubMed 15271750

  • 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.

    PubMed 16850003

  • 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.

    PubMed 10102312

  • 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.

    PubMed 7856895

  • 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.

    PubMed 17562739

  • 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.

    PubMed 17712056

  • 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.

    PubMed 18604519

  • 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.

    PubMed 23184440

  • 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.

    PubMed 19921148

  • 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.

    PubMed 24339292

  • 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.

    PubMed 26866753

  • 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.

    PubMed 16229689

Questions about this trial

What is this clinical trial studying?

An observational study of Intubation, run by Indiana University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First Pass Success (time frame: Immediately at the time of the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02885298, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.

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