NCT03624439

Brief Summary

Intrabronal intubation is one of the basic methods of airway protection during cardiac surgery. The use of double-lumen tubes in the implementation of a standard method based on macintosh laryngoscope may cause the prolongation of the procedure especially in the case of difficult airways. The aim of the study was to match the effectiveness of endotracheal intubation using a standard Macontosh laryngskop and a normal double-lumen tube versus the ETView DL tube.

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 Aug 2018

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

First Submitted

Initial submission to the registry

August 7, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

August 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

August 7, 2018

Last Update Submit

July 29, 2019

Conditions

Intubation;DifficultIntubation; Difficult or FailedDifficult Airway

Keywords

double-lumen tubeETViewmedical simulationanesthesiologistdifficult airway

Outcome Measures

Primary Outcomes (1)

  • intubation time

    from taking of the intubation device to successful intubation

    1 day

Secondary Outcomes (6)

  • time to visualize the glottis

    1 day

  • success of the first intubation trial

    1 day

  • overall success rate

    1 day

  • the degree of visibility of the glottis

    1 day

  • Cormack - Lehane grade

    1 day

  • +1 more secondary outcomes

Study Arms (2)

Normal airway

EXPERIMENTAL

normal airway. the language has not been inflated. the instructor assessed the difficulty of intubation based on the Cormack - Lehane scale to the first degree

Device: Standard double-lumen tubeDevice: Double-Lumen Tube Vivasight-DL

Difficult airway

EXPERIMENTAL

dofficult airway. Difficult airways were obtained by means of language inflation using a simulator control panel, so as to obtain the degree of intubation difficulty assessed by an independent anesthesiologist to the third degree according to the Cormack-Lehane scale

Device: Standard double-lumen tubeDevice: Double-Lumen Tube Vivasight-DL

Interventions

Standard double-lumen tubeDEVICE

intubation using standard double-lumen tube with Macintosh laryngoscope

Difficult airwayNormal airway
Double-Lumen Tube Vivasight-DLDEVICE

intubation using Double-Lumen Video Tube Vivasight-DL with Macintosh laryngoscope

Difficult airwayNormal airway

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • anesthesiologist or a person in the course of specialization
  • consent voluntary participation in the study

You may not qualify if:

  • refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Lazarski University

Warsaw, Masovian Voivodeship, 02-662, Poland

Location

Related Publications (2)

  • Bialka S, Copik M, Rybczyk K, Owczarek A, Jedrusik E, Czyzewski D, Filipowski M, Rivas E, Ruetzler K, Szarpak L, Misiolek H. Assessment of changes of regional ventilation distribution in the lung tissue depending on the driving pressure applied during high frequency jet ventilation. BMC Anesthesiol. 2018 Jul 31;18(1):101. doi: 10.1186/s12871-018-0552-2.

    PMID: 30064377BACKGROUND

  • 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 Officials

  • Lukasz Szarpak, PhD

    Lazarski University

    PRINCIPAL INVESTIGATOR

  • Jacek Smereka, Phd

    Wroclaw Medical University

    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
Associate Professor

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 10, 2018

Study Start

August 7, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

July 31, 2019

Record last verified: 2019-07

Locations

PL(1)