Evaluation of the Double-Lumen Tube Vivasight-DL vs. Standard Duble-lumen Tube in Normal and Difficult Airway Scenarios: A Prospective, Randomized, Crossover, Simulation Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- intubation time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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
Intervention: Standard double-lumen tube (Device)
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
Intervention: Double-Lumen Tube Vivasight-DL (Device)
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
Intervention: Standard double-lumen tube (Device)
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
Intervention: Double-Lumen Tube Vivasight-DL (Device)
Outcomes
Primary Outcomes
intubation time
Time Frame: 1 day
from taking of the intubation device to successful intubation
Secondary Outcomes
- time to visualize the glottis(1 day)
- overall success rate(1 day)
- success of the first intubation trial(1 day)
- Cormack - Lehane grade(1 day)
- ease of use(1 day)
- the degree of visibility of the glottis(1 day)
Investigators
Łukasz Szarpak
Associate Professor
Lazarski University