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

NCT ID: NCT04116333

Last Updated: 2019-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-09

Study Completion Date

2019-10-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intubation, Intratracheal Advanced Cardiac Life Support

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will be randomized to perform either Macintosh laryngoscope or Macintosh laryngoscope with endotracheal tube introducer first, using the envelope method. After completing these initial interventions, they will use the second method.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will be aware of the general nature of the study, but they will be blinded to specific objectives of the study

Study Groups

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ML + ETI

Intubation with using endotracheal tube introducer with the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.

Group Type EXPERIMENTAL

Endotracheal tube introducer

Intervention Type DEVICE

Use of endotracheal tube introducer with the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.

Macintosh laryngoscope

Intervention Type DEVICE

Use of the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.

ML

Intubation with using the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.

Group Type ACTIVE_COMPARATOR

Macintosh laryngoscope

Intervention Type DEVICE

Use of the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.

Interventions

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Endotracheal tube introducer

Use of endotracheal tube introducer with the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.

Intervention Type DEVICE

Macintosh laryngoscope

Use of the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participants who want to participate the study

Exclusion Criteria

* Participants who do not want to participate the study
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Derince Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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ASIM ENES Ă–ZBEK

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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ASIM E OZBEK, M.D.

Role: CONTACT

+1-443-800-0458

References

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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.

Reference Type BACKGROUND
PMID: 28122885 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21796098 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26472995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29700123 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26472994 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11339725 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17681639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27785883 (View on PubMed)

Other Identifiers

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2019-79

Identifier Type: -

Identifier Source: org_study_id

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