NCT02804451

Brief Summary

The aim of the study was to compare the intubation time and effectiveness, the grade of larynx visibility, and the ease of intubation in adults performed by nurses using 4 devices: a Macintosh blade laryngoscope (MAC), and a TruView EVO2 (EVO2), TruView EVO2 PCD (PCD), and ETView SL (ETView) laryngoscope, in simulated CPR settings with and without CC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

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

December 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
Last Updated

June 17, 2016

Status Verified

June 1, 2016

Enrollment Period

3 months

First QC Date

June 11, 2016

Last Update Submit

June 14, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • time to the first ventilation attempt

    1 day

Secondary Outcomes (5)

  • time to visualize the larynx

    1 day

  • time to introduce the endotracheal tube through the vocal cords

    1 day

  • success rate

    1 day

  • degree of larynx visibility

    1 day

  • ease of intubation technique

    1 day

Study Arms (2)

Intubation without chest compression

EXPERIMENTAL

normal airway, without chest compression during intubation.

Device: Macintosh laryngoscopeDevice: TruView EVO2 laryngoscopeDevice: TruView EVO2 PCD laryngoscopeDevice: ETView SL

Intubation with uninterrupted chest compression

EXPERIMENTAL

normal airway, with continuous chest compressions

Device: Macintosh laryngoscopeDevice: TruView EVO2 laryngoscopeDevice: TruView EVO2 PCD laryngoscopeDevice: ETView SL

Interventions

intubation with standard macintosh larygoscope; gold standard

Also known as: MAC
Intubation with uninterrupted chest compressionIntubation without chest compression

A TruView EVO2 laryngoscope with blade size 3 (EVO2; Truphatek Holdings, Ltd., Netanya, Israel),

Also known as: EVO2
Intubation with uninterrupted chest compressionIntubation without chest compression

A TruView EVO2 PCD laryngoscope with blade size 3 (PCD; Truphatek Interbational Ltd., Netanya, Israel),

Also known as: PCD
Intubation with uninterrupted chest compressionIntubation without chest compression
ETView SLDEVICE

An ETView SL (ETView; ETViewLtd, Misgav, Israel) ednotracheal tube

Also known as: ETView
Intubation with uninterrupted chest compressionIntubation without chest compression

Eligibility Criteria

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

You may qualify if:

  • had not received any training in endotracheal intubation with videolaryngoscopy before the study,
  • had nursing specialization in anaesthesiology or emergency medicine,
  • presented with no wrist or low back diseases or pregnancy.

You may not qualify if:

  • not meet the above criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw, Department of Emergency Medicine

Warsaw, Masovia, 02-005, 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.

    PMID: 26020389BACKGROUND

Study Officials

  • Lukasz Szarpak, PhD

    Medical University of Warsaw

    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
Principal Investigator

Study Record Dates

First Submitted

June 11, 2016

First Posted

June 17, 2016

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 17, 2016

Record last verified: 2016-06

Locations