NCT02741921

Brief Summary

The investigators sought to compare the time to intubation and success rate of the endotracheal intubation using standard double-lumen tube and video tube ETView DL in an adult cadaver model in normal and difficult airway conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 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

November 1, 2015

Completed
4 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
1 month until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
Last Updated

April 18, 2016

Status Verified

April 1, 2016

Enrollment Period

4 months

First QC Date

April 13, 2016

Last Update Submit

April 15, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time required for endotracheal intubation

    time from pick up the tube to first ventilation

    1 day

Secondary Outcomes (3)

  • Time required for visual confirmation of double lumen tube position position

    1 day

  • success rate of intubation attempt

    1 day

  • Ease of intubation

    1 day

Study Arms (2)

Normal airway

EXPERIMENTAL

intubation with normal airway Cormack-Lehane classivication I

Device: VivaSight DLDevice: conventional double-lumen tube

difficult airway

EXPERIMENTAL

intubation with difficult airway Cormack-Lehane classivication III

Device: VivaSight DLDevice: conventional double-lumen tube

Interventions

intubation using VivaSight DL tube

Normal airwaydifficult airway

intubation using conventional double-lumen tube

Normal airwaydifficult airway

Eligibility Criteria

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

You may qualify if:

  • fresh adult cadavers

You may not qualify if:

  • cadavers with face injures

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 (2)

  • 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
  • Szarpak L, Kurowski A, Zasko P, Karczewska K, Czyzewski L, Bogdanski L, Adamczyk P, Truszewski Z. Double-lumen tube tracheal intubation in a manikin model using the VivaSight Double Lumen: a randomized controlled comparison with the Macintosh laryngoscope. Am J Emerg Med. 2016 Jan;34(1):103-4. doi: 10.1016/j.ajem.2015.10.018. Epub 2015 Oct 23. No abstract available.

    PMID: 26527175BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 18, 2016

Study Start

November 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 18, 2016

Record last verified: 2016-04

Locations