Effect of Using Endotracheal Tube Introducer for Intubation During Mechanical Chest Compressions in a Manikin

Effect of Using Endotracheal Tube Introducer for Intubation During Mechanical Chest Compressions in a Manikin: Randomized, Prospective, Crossover Study

The aim of this study was to compare the impact of using ETI with the Macintosh laryngoscope on first pass success rates of the final year students of medical school on a manikin during continuous chest compressions with mechanical compression device.

Study Overview

• Status: Unknown
• Conditions: Intubation, Intratracheal; Advanced Cardiac Life Support
• Intervention / Treatment: Device: Endotracheal tube introducer; Device: Macintosh laryngoscope

Detailed Description

Fifty-two final year students of Kocaeli University Medical School will participate to the study. The participants will complete the one-hour training lecture on the use of the Macintosh laryngoscope (ML) and the endotracheal tube introducer (ETI) that will be instructed by an emergency medicine specialist. The information section will be followed by a chance of practice each endotracheal intubation method once by using the ML with and without the ETI on the manikin.

Mechanical compression device will be used to perform chest compressions. The manikin will be placed on an ambulance stretcher in a supine position. Airway interventions will be performed in a sitting position on a seat that will be adjusted to the same height with the ambulance seat. The airway kit will be placed beside the head of the manikin.

Each participant will perform 2 airway interventions. Participants will be allowed for maximum 2 attempts for each method. Each procedure will be recorded to the video camera. The participants will be aware of the video camera. Following the interventions each participant will be asked to grade the difficulty of the both methods on a 5-point Likert scale defined as 1: very easy, 2: easy, 3: moderate, 4: difficult and 5: very difficult. The participants will be asked for whether they have prior clinical experience or not with ML or/and ML with ETI use.

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants who want to participate the study

Exclusion Criteria:

• Participants who do not want to participate the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ML + ETI; Intubation with using endotracheal tube introducer with the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.	Device: Endotracheal tube introducer; Use of endotracheal tube introducer with the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.; Device: Macintosh laryngoscope; Use of the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.
ACTIVE_COMPARATOR: ML; Intubation with using the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.	Device: Macintosh laryngoscope; Use of the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First pass success	Comparison of the first pass success of the Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer groups	1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to endotracheal intubation	The mean time to successful endotracheal intubation of Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer groups	1 minute
Second endotracheal intubation attempt success rates	Second endotracheal intubation attempt success rates of Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer groups	1 minute
Difficulty level of each method according to the Likert scale	Grading the difficulty of the Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer on a 5-point Likert scale	1 minute

Collaborators and Investigators

• Sponsor: Derince Training and Research Hospital

Publications and helpful links

General Publications

• Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.
• Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available. Erratum In: Circulation. 2015 Dec 15;132(24):e385.
• Park L, Zeng I, Brainard A. Systematic review and meta-analysis of first-pass success rates in emergency department intubation: Creating a benchmark for emergency airway care. Emerg Med Australas. 2017 Feb;29(1):40-47. doi: 10.1111/1742-6723.12704. Epub 2016 Oct 27.
• McNally B, Robb R, Mehta M, Vellano K, Valderrama AL, Yoon PW, Sasson C, Crouch A, Perez AB, Merritt R, Kellermann A; Centers for Disease Control and Prevention. Out-of-hospital cardiac arrest surveillance --- Cardiac Arrest Registry to Enhance Survival (CARES), United States, October 1, 2005--December 31, 2010. MMWR Surveill Summ. 2011 Jul 29;60(8):1-19.
• Kleinman ME, Perkins GD, Bhanji F, Billi JE, Bray JE, Callaway CW, de Caen A, Finn JC, Hazinski MF, Lim SH, Maconochie I, Nadkarni V, Neumar RW, Nikolaou N, Nolan JP, Reis A, Sierra AF, Singletary EM, Soar J, Stanton D, Travers A, Welsford M, Zideman D. ILCOR Scientific Knowledge Gaps and Clinical Research Priorities for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care: A Consensus Statement. Circulation. 2018 May 29;137(22):e802-e819. doi: 10.1161/CIR.0000000000000561. Epub 2018 Apr 26. Erratum In: Circulation. 2018 Jul 31;138(5):e77.
• Brooks SC, Anderson ML, Bruder E, Daya MR, Gaffney A, Otto CW, Singer AJ, Thiagarajan RR, Travers AH. Part 6: Alternative Techniques and Ancillary Devices for Cardiopulmonary Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S436-43. doi: 10.1161/CIR.0000000000000260. No abstract available.
• Le DH, Reed DB, Weinstein G, Gregory M, Brown LH. Paramedic use of endotracheal tube introducers for the difficult airway. Prehosp Emerg Care. 2001 Apr-Jun;5(2):155-8. doi: 10.1080/10903120190940038.
• Kovacs G, Law JA, McCrossin C, Vu M, Leblanc D, Gao J. A comparison of a fiberoptic stylet and a bougie as adjuncts to direct laryngoscopy in a manikin-simulated difficult airway. Ann Emerg Med. 2007 Dec;50(6):676-85. doi: 10.1016/j.annemergmed.2007.05.022. Epub 2007 Aug 3.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 9, 2019
• Primary Completion (ANTICIPATED): October 10, 2019
• Study Completion (ANTICIPATED): October 10, 2019

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (ACTUAL): October 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2019-79

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No