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ETI During Spinal Trauma

Sponsor
International Institute of Rescue Research and Education (Other)
Overall Status
Unknown status
CT.gov ID
NCT02295631
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
30
Duration (Days)
152.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study was to compare time, success rates of different tracheal tubes (standard tube and ETView VivaSight SL) for intubation with an immobilized cervical spine in a standardized manikin model.

Condition or Disease Intervention/Treatment Phase
  • Device: Standard tracheal tube
  • Device: ETView VivaSight SL
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Comparison of Conventional Tube and ETView VivaSight SL Tube for Tracheal Intubation in Patients With a Cervical Spine Immobilisation. A Randomized Cross-over Manikin Trial.
Study Start Date :
Nov 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2014
Anticipated Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: ETI during immobilized spine (oral intubation)

intubation with immobilized cervical spine endotracheal intubation with immobilized cervical spine

Device: Standard tracheal tube
ETI with standard tracheal tube and Macintosh laryngoscope

Device: ETView VivaSight SL
ETI with ETView VivaSight SL
Experimental: ETI during immobilized spine (nasal intubation)

intubation with immobilized cervical spine endotracheal intubation with immobilized cervical spine

Device: Standard tracheal tube
ETI with standard tracheal tube and Macintosh laryngoscope

Device: ETView VivaSight SL
ETI with ETView VivaSight SL

Outcome Measures

Primary Outcome Measures

  1. Success of intubation [1 day]

    effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants

Secondary Outcome Measures

  1. Intubation time [1 day]

    time in seconds required for a successful intubation attempt

  2. Cormack-Lehane grading [1 day]

    self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)

  3. Preferred ETI device [1day]

    participants were asked which method of ETI they would prefer in a real-life resuscitation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • give voluntary consent to participate in the study

  • minimum 1 year of work experience in emergency medicine

  • experienced emergency medicine personnel (physicians, nurses, paramedics)

Exclusion Criteria:

  • not meet the above criteria

  • wrist or low back diseases

Contacts and Locations

Locations

Site City State Country Postal Code
1 International Institute of Rescue Research and Education Warsaw Masovia Poland 03-122

Sponsors and Collaborators

  • International Institute of Rescue Research and Education

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lukasz Szarpak, Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT02295631
Other Study ID Numbers:
  • ETI/2014/42
First Posted:
Nov 20, 2014
Last Update Posted:
Dec 2, 2014
Last Verified:
Nov 1, 2014
Additional relevant MeSH terms:
Heart Arrest

Study Results

No Results Posted as of Dec 2, 2014