Intubation During Spinal Immobilization

NCT ID: NCT02733536

Last Updated: 2017-07-27

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

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-04-30

Brief Summary

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The aim was to evaluate the performance of the C-MAC compared with Macintosh when performed in patients with immobilized cervical spine by unexperienced physicians.

Detailed Description

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Conditions

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Endotracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Scenario A

manikin with normal standard airway

Group Type EXPERIMENTAL

Standard endotracheal tube

Intervention Type DEVICE

1\) Direct laryngoscopy using a Macintosh laryngoscope with size 3 blade (Mercury Medical, Clearwater, FL, USA) with a conventional 7.0 mm internal diameter (ID) tracheal tube

C-MAC

Intervention Type DEVICE

C-MAC introduced with a h size 3 blade.

Scenario B

Cervical immobilization using a standard Patriot cervical extraction collar (Oessur Americas, Foothill Ranch, CA, USA), applied to the manikin's neck by an instructor.

Group Type EXPERIMENTAL

Standard endotracheal tube

Intervention Type DEVICE

1\) Direct laryngoscopy using a Macintosh laryngoscope with size 3 blade (Mercury Medical, Clearwater, FL, USA) with a conventional 7.0 mm internal diameter (ID) tracheal tube

C-MAC

Intervention Type DEVICE

C-MAC introduced with a h size 3 blade.

Scenario C

Cervical immobilization using a vacuum mattress (Ferno-Washington, Inc. Wilmington, OH, USA), applied to the manikin's neck by an instructor

Group Type EXPERIMENTAL

Standard endotracheal tube

Intervention Type DEVICE

1\) Direct laryngoscopy using a Macintosh laryngoscope with size 3 blade (Mercury Medical, Clearwater, FL, USA) with a conventional 7.0 mm internal diameter (ID) tracheal tube

C-MAC

Intervention Type DEVICE

C-MAC introduced with a h size 3 blade.

Interventions

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Standard endotracheal tube

1\) Direct laryngoscopy using a Macintosh laryngoscope with size 3 blade (Mercury Medical, Clearwater, FL, USA) with a conventional 7.0 mm internal diameter (ID) tracheal tube

Intervention Type DEVICE

C-MAC

C-MAC introduced with a h size 3 blade.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* give voluntary consent to participate in the study
* limited experience (\<5 intubations) with "real-life" intubation using direct laryngoscopy
* novice phhysicians

Exclusion Criteria

* not meet the above criteria
* practice with any videolaryngoscopy
* wrist or low back diseases
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Łukasz Szarpak

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Łukasz Szarpak, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

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Medical University of Warsaw, Department of Emergency Medicine

Warsaw, Masovia, Poland

Site Status

Countries

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Poland

References

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Truszewski Z, Szarpak L, Smereka J, Kurowski A, Evrin T, Czyzewski L. Comparison of the VivaSight single lumen endotracheal tube and the Macintosh laryngoscope for emergency intubation by experienced paramedics in a standardized airway manikin with restricted access: a randomized, crossover trial. Am J Emerg Med. 2016 May;34(5):929-30. doi: 10.1016/j.ajem.2016.02.054. Epub 2016 Feb 27. No abstract available.

Reference Type BACKGROUND
PMID: 26979260 (View on PubMed)

Bogdanski L, Truszewski Z, Kurowski A, Czyzewski L, Zasko P, Adamczyk P, Szarpak L. Simulated endotracheal intubation of a patient with cervical spine immobilization during resuscitation: a randomized comparison of the Pentax AWS, the Airtraq, and the McCoy Laryngoscopes. Am J Emerg Med. 2015 Dec;33(12):1814-7. doi: 10.1016/j.ajem.2015.09.005. Epub 2015 Sep 21.

Reference Type BACKGROUND
PMID: 26494629 (View on PubMed)

Gawlowski P, Smereka J, Madziala M, Szarpak L, Frass M, Robak O. Comparison of the Macintosh laryngoscope and blind intubation via the iGEL for Intubation With C-spine immobilization: A Randomized, crossover, manikin trial. Am J Emerg Med. 2017 Mar;35(3):484-487. doi: 10.1016/j.ajem.2016.11.064. Epub 2016 Nov 30.

Reference Type BACKGROUND
PMID: 28041757 (View on PubMed)

Karczewska K, Szarpak L, Smereka J, Dabrowski M, Ladny JR, Wieczorek W, Robak O, Frass M, Ahuja S, Ruetzler K. ET-View compared to direct laryngoscopy in patients with immobilized cervical spine by unexperienced physicians: A randomized crossover manikin trial. Anaesthesiol Intensive Ther. 2017;49(4):274-282. doi: 10.5603/AIT.a2017.0047. Epub 2017 Sep 27.

Reference Type DERIVED
PMID: 28953308 (View on PubMed)

Truszewski Z, Krajewski P, Fudalej M, Smereka J, Frass M, Robak O, Nguyen B, Ruetzler K, Szarpak L. A comparison of a traditional endotracheal tube versus ETView SL in endotracheal intubation during different emergency conditions: A randomized, crossover cadaver trial. Medicine (Baltimore). 2016 Nov;95(44):e5170. doi: 10.1097/MD.0000000000005170.

Reference Type DERIVED
PMID: 27858851 (View on PubMed)

Other Identifiers

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23.01.2017.IRB

Identifier Type: -

Identifier Source: org_study_id

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