Duble Lumen Intubation

NCT ID: NCT03624439

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-07

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intubation;Difficult Intubation; Difficult or Failed Difficult Airway

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal airway

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

Group Type EXPERIMENTAL

Standard double-lumen tube

Intervention Type DEVICE

intubation using standard double-lumen tube with Macintosh laryngoscope

Double-Lumen Tube Vivasight-DL

Intervention Type DEVICE

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

Difficult airway

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

Group Type EXPERIMENTAL

Standard double-lumen tube

Intervention Type DEVICE

intubation using standard double-lumen tube with Macintosh laryngoscope

Double-Lumen Tube Vivasight-DL

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard double-lumen tube

intubation using standard double-lumen tube with Macintosh laryngoscope

Intervention Type DEVICE

Double-Lumen Tube Vivasight-DL

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* refusal to participate in the study
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lazarski University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Łukasz Szarpak

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lukasz Szarpak, PhD

Role: PRINCIPAL_INVESTIGATOR

Lazarski University

Jacek Smereka, Phd

Role: PRINCIPAL_INVESTIGATOR

Wroclaw Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine, Lazarski University

Warsaw, Masovian Voivodeship, Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30064377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26527175 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ETI_2018_DL1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ETI During Intubation
NCT02295618 COMPLETED NA