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

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ClinicalTrials.gov Identifier: NCT04116333
Recruitment Status : Not yet recruiting
First Posted : October 4, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
ASIM ENES ÖZBEK, Derince Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Intubation, Intratracheal Advanced Cardiac Life Support Device: Endotracheal tube introducer Device: Macintosh laryngoscope Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Masking Description: Participants will be aware of the general nature of the study, but they will be blinded to specific objectives of the study
Primary Purpose: Treatment
Official Title: Effect of Using Endotracheal Tube Introducer for Intubation During Mechanical Chest Compressions in a Manikin: Randomized, Prospective, Crossover Study
Estimated Study Start Date : October 9, 2019
Estimated Primary Completion Date : October 10, 2019
Estimated Study Completion Date : October 10, 2019

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.




Primary Outcome Measures :
  1. First pass success [ Time Frame: 1 minute ]
    Comparison of the first pass success of the Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer groups


Secondary Outcome Measures :
  1. Time to endotracheal intubation [ Time Frame: 1 minute ]
    The mean time to successful endotracheal intubation of Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer groups

  2. Second endotracheal intubation attempt success rates [ Time Frame: 1 minute ]
    Second endotracheal intubation attempt success rates of Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer groups

  3. Difficulty level of each method according to the Likert scale [ Time Frame: 1 minute ]
    Grading the difficulty of the Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer on a 5-point Likert scale



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants who want to participate the study

Exclusion Criteria:

  • Participants who do not want to participate the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04116333


Contacts
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Contact: ASIM E OZBEK, M.D. +1-443-800-0458 drenesozbek@gmail.com

Sponsors and Collaborators
Derince Training and Research Hospital
Publications:
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez 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. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.

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Responsible Party: ASIM ENES ÖZBEK, Principal Investigator, Derince Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04116333    
Other Study ID Numbers: 2019-79
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No