NCT04116333

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

October 9, 2019

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2019

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

1 day

First QC Date

September 25, 2019

Last Update Submit

October 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • First pass success

    Comparison of the first pass success of the Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer groups

    1 minute

Secondary Outcomes (3)

  • Time to endotracheal intubation

    1 minute

  • Second endotracheal intubation attempt success rates

    1 minute

  • Difficulty level of each method according to the Likert scale

    1 minute

Study Arms (2)

ML + ETI

EXPERIMENTAL

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

Device: Endotracheal tube introducerDevice: Macintosh laryngoscope

ML

ACTIVE COMPARATOR

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

Device: Macintosh laryngoscope

Interventions

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

ML + ETI

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

MLML + ETI

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants who want to participate the study

You may not qualify if:

  • Participants who do not want to participate the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

    PMID: 28122885BACKGROUND
  • 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.

    PMID: 21796098BACKGROUND
  • 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.

    PMID: 26472995BACKGROUND
  • 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.

    PMID: 29700123BACKGROUND
  • 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.

    PMID: 26472994BACKGROUND
  • 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.

    PMID: 11339725BACKGROUND
  • 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.

    PMID: 17681639BACKGROUND
  • 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.

    PMID: 27785883BACKGROUND

Central Study Contacts

ASIM E OZBEK, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be aware of the general nature of the study, but they will be blinded to specific objectives of the study
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2019

First Posted

October 4, 2019

Study Start

October 9, 2019

Primary Completion

October 10, 2019

Study Completion

October 10, 2019

Last Updated

October 4, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share