Brief Summary

The objective of this study is to compared effectiveness of intubation using ETView VivaSight SL and standard tracheal tube during resuscitation performed by a novice-physicians.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

Same day

First QC Date

November 18, 2014

Last Update Submit

November 27, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to intubation

    time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure.

    1 day

Secondary Outcomes (2)

  • Success of intubation

    1 day

  • Cormack-Lehan scale

    1 day

Study Arms (2)

ETI with chest compressions

EXPERIMENTAL

endotracheal intubation (ETI) during child mannikin resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.).

Device: Standard tracheal tubeDevice: ETView VivaSight SL

ETI without chest compressions

EXPERIMENTAL

Endotracheal intubation of child mannikin during resuscitation without chest compressions.

Device: Standard tracheal tubeDevice: ETView VivaSight SL

Interventions

Intubation using Macintosh laryngoscope and standard tracheal tube

ETI with chest compressionsETI without chest compressions

Intubation using ETView VivaSight SL

ETI with chest compressionsETI without chest compressions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • give voluntary consent to participate in the study
  • maximum 1 year of work experience in medicine
  • maximum 10 clinical intubations

You may not qualify if:

  • not meet the above criteria
  • wrist or low back diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Institute of Rescue Research and Education

Warsaw, Masovia, 03-122, Poland

Location

Related Publications (1)

  • Kurowski A, Szarpak L, Truszewski Z, Czyzewski L. Can the ETView VivaSight SL Rival Conventional Intubation Using the Macintosh Laryngoscope During Adult Resuscitation by Novice Physicians?: A Randomized Crossover Manikin Study. Medicine (Baltimore). 2015 May;94(21):e850. doi: 10.1097/MD.0000000000000850.

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Lukasz Szarpak

    Institute of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lukasz Szarpak

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 20, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations