NCT02295670

Brief Summary

Endotracheal intubation (ETI) is perceived as the optimal method of providing and maintaining a clear and secure airway. The 2010 European Resuscitation Council (ERC) guidelines emphasized the importance of minimal interruption during cardiopulmonary resuscitation (CPR). These guidelines also suggest that skilled operators should be able to secure the airway without interrupting chest compression. The aim of the study was to compare time and success rates of the Vividtrac video-laryngoscope and the Miller laryngoscope for emergency intubation during simulated pediatric CPR.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

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
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

1 month

First QC Date

November 18, 2014

Last Update Submit

November 18, 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-Lehane grading

    1 day

Study Arms (2)

Endotracheal intubation without chest compressions

EXPERIMENTAL

Endotracheal intubation of mannikin during resuscitation without chest compressions.

Device: VividtracDevice: MIL

Endotracheal intubation with uninterrupted chest compressions

EXPERIMENTAL

Endotracheal intubation of mannikin during 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: VividtracDevice: MIL

Interventions

VividtracDEVICE

video-laryngoscopy

Endotracheal intubation with uninterrupted chest compressionsEndotracheal intubation without chest compressions
MILDEVICE

direct-laryngoscopy

Also known as: miller larygoscopy
Endotracheal intubation with uninterrupted chest compressionsEndotracheal intubation 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
  • Paramedic student

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, Masovie, 03-122, Poland

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

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

December 1, 2014

Study Completion

December 1, 2014

Last Updated

November 20, 2014

Record last verified: 2014-11

Locations