Airway Management Skills Amongst Anesthesia Providers

Airway Management Clinical Trial

Official title:

The Proficiency and Efficiency of Airway Management Skills Amongst Anesthesia Providers: A Multicenter Baseline Assessment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05055401
• Other study ID #: Pro00104249
• Status: Enrolling by invitation
• Start date: October 22, 2021
• Est. completion date: September 2024

Study information

• Verified date: April 2023
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to evaluate the efficiency and proficiency of three common airway management techniques amongst among anesthesia providers who maintain airway management privileges in our health system.

Description:

Airway management may take place in a variety of settings with varying degrees of urgency, ranging from performance for elective operative procedures to life-threatening emergencies. An appropriate psychomotor skill set is needed to perform the procedures utilized for airway management, and the time required to do so may impact patient outcomes. Prolonged periods of apnea and accompanying hypoxia can lead to brain damage or death. This research is designed to evaluate the proficiency of anesthesia providers who are responsible for practicing airway management in hospitals or health systems in the United States, including Anesthesiologists, Certified Registered Nurse Anesthetists, and Anesthesiology Assistants. We are attempting to establish a baseline level of proficiency by quantifying the time it takes to achieve successful airway management and the number of attempts required to do so utilizing a high fidelity manikin programmed to simulate various physiological conditions. This baseline information could then be used to manage the decisions made by hospitals or health systems related to airway management in the future, or to redefine the policies and procedures established for performing these procedures.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Informed consent is obtained from the participant

• Participants are presently employed as an anesthesiologist (previously completed an anesthesiology residency), CRNA or AA at a participating institution

• Participants have active airway management privileges with their institution

Exclusion Criteria:

• Participants are not employed by their institution

• Refusal of the participant to sign a consent

Related Conditions & MeSH terms

• Airway Management

Intervention

Procedure:
• Direct Laryngoscopy
The participant will perform a direct laryngoscopy on a Laerdal SimMan 3G under healthy conditions and under limited cervical range of motion.
• Laryngeal Mask Airways
The participant will perform LMA placement on a Laerdal SimMan 3G under healthy conditions and under full tongue edema.
• Video Laryngoscopy
The participant will perform video laryngoscopy on a Laerdal SimMan 3G under healthy conditions and under half tongue edema with pharyngeal obstruction.

Locations

Country	Name	City	State
United States	Prisma Health	Greenville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Prisma Health-Upstate	Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (26)

Ambrosio A, Pfannenstiel T, Bach K, Cornelissen C, Gaconnet C, Brigger MT. Difficult airway management for novice physicians: a randomized trial comparing direct and video-assisted laryngoscopy. Otolaryngol Head Neck Surg. 2014 May;150(5):775-8. doi: 10.1177/0194599814521380. Epub 2014 Jan 29. — View Citation

Bhattacharjee S, Maitra S, Baidya DK. A comparison between video laryngoscopy and direct laryngoscopy for endotracheal intubation in the emergency department: A meta-analysis of randomized controlled trials. J Clin Anesth. 2018 Jun;47:21-26. doi: 10.1016/j.jclinane.2018.03.006. Epub 2018 Mar 14. — View Citation

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Carlson JN, Crofts J, Walls RM, Brown CA 3rd. Direct Versus Video Laryngoscopy for Intubating Adult Patients with Gastrointestinal Bleeding. West J Emerg Med. 2015 Dec;16(7):1052-6. doi: 10.5811/westjem.2015.8.28045. Epub 2015 Dec 1. — View Citation

Cortellazzi P, Caldiroli D, Byrne A, Sommariva A, Orena EF, Tramacere I. Defining and developing expertise in tracheal intubation using a GlideScope((R)) for anaesthetists with expertise in Macintosh direct laryngoscopy: an in-vivo longitudinal study. Anaesthesia. 2015 Mar;70(3):290-5. doi: 10.1111/anae.12878. Epub 2014 Oct 1. — View Citation

Deutsch ES, Christenson T, Curry J, Hossain J, Zur K, Jacobs I. Multimodality education for airway endoscopy skill development. Ann Otol Rhinol Laryngol. 2009 Feb;118(2):81-6. doi: 10.1177/000348940911800201. — View Citation

Griesdale DE, Liu D, McKinney J, Choi PT. Glidescope(R) video-laryngoscopy versus direct laryngoscopy for endotracheal intubation: a systematic review and meta-analysis. Can J Anaesth. 2012 Jan;59(1):41-52. doi: 10.1007/s12630-011-9620-5. Epub 2011 Nov 1. — View Citation

Grundgeiger T, Roewer N, Grundgeiger J, Hurtienne J, Happel O. Body posture during simulated tracheal intubation: GlideScope((R)) videolaryngoscopy vs Macintosh direct laryngoscopy for novices and experts. Anaesthesia. 2015 Dec;70(12):1375-81. doi: 10.1111/anae.13190. Epub 2015 Sep 5. — View Citation

Joffe AM, Aziz MF, Posner KL, Duggan LV, Mincer SL, Domino KB. Management of Difficult Tracheal Intubation: A Closed Claims Analysis. Anesthesiology. 2019 Oct;131(4):818-829. doi: 10.1097/ALN.0000000000002815. — View Citation

Jones PM, Armstrong KP, Armstrong PM, Cherry RA, Harle CC, Hoogstra J, Turkstra TP. A comparison of glidescope videolaryngoscopy to direct laryngoscopy for nasotracheal intubation. Anesth Analg. 2008 Jul;107(1):144-8. doi: 10.1213/ane.0b013e31816d15c9. — View Citation

Kennedy CC, Cannon EK, Warner DO, Cook DA. Advanced airway management simulation training in medical education: a systematic review and meta-analysis. Crit Care Med. 2014 Jan;42(1):169-78. doi: 10.1097/CCM.0b013e31829a721f. — View Citation

Lewis SR, Butler AR, Parker J, Cook TM, Schofield-Robinson OJ, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adult patients requiring tracheal intubation: a Cochrane Systematic Review. Br J Anaesth. 2017 Sep 1;119(3):369-383. doi: 10.1093/bja/aex228. — View Citation

Liu L, Tanigawa K, Kusunoki S, Tamura T, Ota K, Yamaga S, Kida Y, Otani T, Sadamori T, Takeda T, Iwasaki Y, Hirohashi N. Tracheal intubation of a difficult airway using Airway Scope, Airtraq, and Macintosh laryngoscope: a comparative manikin study of inexperienced personnel. Anesth Analg. 2010 Apr 1;110(4):1049-55. doi: 10.1213/ANE.0b013e3181d2aad7. — View Citation

Liu TT, Li L, Wan L, Zhang CH, Yao WL. Videolaryngoscopy vs. Macintosh laryngoscopy for double-lumen tube intubation in thoracic surgery: a systematic review and meta-analysis. Anaesthesia. 2018 Aug;73(8):997-1007. doi: 10.1111/anae.14226. Epub 2018 Feb 6. — View Citation

Martin LD, Mhyre JM, Shanks AM, Tremper KK, Kheterpal S. 3,423 emergency tracheal intubations at a university hospital: airway outcomes and complications. Anesthesiology. 2011 Jan;114(1):42-8. doi: 10.1097/ALN.0b013e318201c415. — View Citation

Mosier JM, Stolz U, Chiu S, Sakles JC. Difficult airway management in the emergency department: GlideScope videolaryngoscopy compared to direct laryngoscopy. J Emerg Med. 2012 Jun;42(6):629-34. doi: 10.1016/j.jemermed.2011.06.007. Epub 2011 Sep 10. — View Citation

Pieters B, Maassen R, Van Eig E, Maathuis B, Van Den Dobbelsteen J, Van Zundert A. Indirect videolaryngoscopy using Macintosh blades in patients with non-anticipated difficult airways results in significantly lower forces exerted on teeth relative to classic direct laryngoscopy: a randomized crossover trial. Minerva Anestesiol. 2015 Aug;81(8):846-54. Epub 2014 Oct 14. — View Citation

Pieters BM, Wilbers NE, Huijzer M, Winkens B, van Zundert AA. Comparison of seven videolaryngoscopes with the Macintosh laryngoscope in manikins by experienced and novice personnel. Anaesthesia. 2016 May;71(5):556-64. doi: 10.1111/anae.13413. Epub 2016 Mar 12. — View Citation

Pieters BMA, Maas EHA, Knape JTA, van Zundert AAJ. Videolaryngoscopy vs. direct laryngoscopy use by experienced anaesthetists in patients with known difficult airways: a systematic review and meta-analysis. Anaesthesia. 2017 Dec;72(12):1532-1541. doi: 10.1111/anae.14057. Epub 2017 Sep 22. — View Citation

Platts-Mills TF, Campagne D, Chinnock B, Snowden B, Glickman LT, Hendey GW. A comparison of GlideScope video laryngoscopy versus direct laryngoscopy intubation in the emergency department. Acad Emerg Med. 2009 Sep;16(9):866-71. doi: 10.1111/j.1553-2712.2009.00492.x. Epub 2009 Aug 6. — View Citation

Robitaille A, Williams SR, Tremblay MH, Guilbert F, Theriault M, Drolet P. Cervical spine motion during tracheal intubation with manual in-line stabilization: direct laryngoscopy versus GlideScope videolaryngoscopy. Anesth Analg. 2008 Mar;106(3):935-41, table of contents. doi: 10.1213/ane.0b013e318161769e. — View Citation

Rothfield KP, Russo SG. Videolaryngoscopy: should it replace direct laryngoscopy? a pro-con debate. J Clin Anesth. 2012 Nov;24(7):593-7. doi: 10.1016/j.jclinane.2012.04.005. — View Citation

Russell T, Khan S, Elman J, Katznelson R, Cooper RM. Measurement of forces applied during Macintosh direct laryngoscopy compared with GlideScope(R) videolaryngoscopy. Anaesthesia. 2012 Jun;67(6):626-31. doi: 10.1111/j.1365-2044.2012.07087.x. Epub 2012 Feb 21. — View Citation

Sakles JC, Mosier J, Patanwala AE, Dicken J. Learning curves for direct laryngoscopy and GlideScope(R) video laryngoscopy in an emergency medicine residency. West J Emerg Med. 2014 Nov;15(7):930-7. doi: 10.5811/westjem.2014.9.23691. Epub 2014 Oct 29. — View Citation

Waddington MS, Paech MJ, Kurowski IH, Reed CJ, Nicholls GJ, Guy DT, Day RE. The influence of gender and experience on intubation ability and technique: a manikin study. Anaesth Intensive Care. 2009 Sep;37(5):791-801. doi: 10.1177/0310057X0903700502. — View Citation

Wetsch WA, Spelten O, Hellmich M, Carlitscheck M, Padosch SA, Lier H, Bottiger BW, Hinkelbein J. Comparison of different video laryngoscopes for emergency intubation in a standardized airway manikin with immobilized cervical spine by experienced anaesthetists. A randomized, controlled crossover trial. Resuscitation. 2012 Jun;83(6):740-5. doi: 10.1016/j.resuscitation.2011.11.024. Epub 2011 Dec 7. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Attempts to Achieve Successful Airway Management	A successful attempt for any of the three procedures will be documented when a participant attaches a bag/valve and attempts a ventilation resulting in the presence of end-tidal carbon dioxide (which will be displayed when the device is properly placed). Failed attempts for any of the three procedures will be documented when a participant attaches a bag/valve device and attempts ventilation for purposes of confirming the presence of end-tidal carbon dioxide (which will not be displayed if the device is improperly placed). Three sequential failed attempts will result in a failure to achieve successful airway management.	Immediate Post-Procedure
Primary	Time Required to Achieve Successful Airway Management	Time will be measured manually via stopwatch. Time measurement for all three procedures will begin when the participant picks up the laryngoscope, video laryngoscope, or LMA having signaled his/her intention to begin the procedure. Time measurement will end upon detection of end-tidal carbon dioxide by the mannikin as evidenced on a standard patient monitor connected to the mannikin for this purpose. Time measurement will continue during failed attempts and subsequent efforts to successfully perform the procedure. Time measurement will be stopped upon successful end-tidal carbon dioxide measurement, three sequential failed attempts to perform a procedure, or after a total of five minutes have passed.	Immediate Post-Procedure