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A Comparison of Vie-Scope and Macintosh Blade Laryngoscopes in Morbidly Obese.

Primary Purpose

Obesity, Morbid, Intubation Complication

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Laryngoscopy with Vie-Scope laryngoscope
Laryngoscopy with Macintosh blade laryngoscope
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity, Morbid focused on measuring morbid obesity, endotracheal intubation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • morbid obesity BMI>40 kg/m2
  • scheduled for elective bariatric procedure
  • no anatomy abnormalities of upper airway

Exclusion Criteria:

  • lack of conscent
  • predicted difficult intubation

Sites / Locations

  • Medical University of Lodz, Poland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Macintosh blade

Vie-Scope

Arm Description

Visualisation of entrance to larynx using Standard Macintosh blade laryngoscope followed by Visualisation of entrance to larynx using Vie-Scope laryngoscope

Visualisation of entrance to larynx using Vie-Scope laryngoscope after visualisation using Macintosh blade laryngoscope

Outcomes

Primary Outcome Measures

Improvement in laryngeal view
Expected improvement in laryngeal view obtained with the use of Vie-Scope laryngoscope

Secondary Outcome Measures

intubation efficiency
Success of intubation using Vie-Scope laryngoscope

Full Information

First Posted
June 22, 2022
Last Updated
August 12, 2022
Sponsor
Medical University of Lodz
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1. Study Identification

Unique Protocol Identification Number
NCT05502120
Brief Title
A Comparison of Vie-Scope and Macintosh Blade Laryngoscopes in Morbidly Obese.
Official Title
A Comparison of Visualization of the Larynx With the Vie Scope Versus Standard Macintosh Laryngoscope in Morbidly Obese Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Lodz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Macintosh laryngoscope is still considered a standard for tracheal intubation, however, visualization of the glottis may be inadequate mainly in morbidly obese patients. The Vie Scope is a novel type of laryngoscope consisting of a straight, shielded, illuminated tube that offers intubation via a bougie using the paraglossal technique. In this prospective, non-randomized study, we tested the research hypothesis that the use of Vie Scope may improve visualization of the larynx in comparison with the Macintosh blade.
Detailed Description
Prior to tracheal intubation, all patients were placed in the head-elevated laryngoscopy position (HELP). All study subjects were anesthetized with the concordance to European Society for Peri-Operative Care of Obese Patient (www.espcop.eu) protocols: proper positioning, pre-oxygenation with CPAP, induction of anesthesia with propofol 2.0 mg kg-1 of corrected body weight; for muscle relaxation rocuronium 0.6 mg kg-1 of ideal body weight (IBW); ketamine 50 mg ; lidocaine 100 mg, and fentanyl 0.1 mg. After achieving 100% neuromuscular block confirmed by TOF-Watch monitoring, laryngoscopy was performed by the anesthesiologist familiar with the use of both Vie Scope and Macintosh blade laryngoscope, and also experienced in bariatric anesthesia. All anesthesiologists participating in the study underwent training with Vie Scope on the manikin model. The evaluation of glottis visualization in direct laryngoscopy using Cormack-Lehane scale (CL) in all patients was performed in sequence using two laryngoscopes: first Macintosh blade laryngoscope (MCL) and then Vie Scope laryngoscope (VS). Tracheal intubation was performed with the VS. The study subjects all received oxygen using nasal CPAP in order to maintain sufficient oxygenation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Intubation Complication
Keywords
morbid obesity, endotracheal intubation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Macintosh blade
Arm Type
Active Comparator
Arm Description
Visualisation of entrance to larynx using Standard Macintosh blade laryngoscope followed by Visualisation of entrance to larynx using Vie-Scope laryngoscope
Arm Title
Vie-Scope
Arm Type
Experimental
Arm Description
Visualisation of entrance to larynx using Vie-Scope laryngoscope after visualisation using Macintosh blade laryngoscope
Intervention Type
Device
Intervention Name(s)
Laryngoscopy with Vie-Scope laryngoscope
Intervention Description
Evaluation of laryngeal view using Vie-Scope laryngoscope, intubation efficacy, complications
Intervention Type
Device
Intervention Name(s)
Laryngoscopy with Macintosh blade laryngoscope
Intervention Description
Evaluation of laryngeal view using stnadard Macintosh blade laryngoscope
Primary Outcome Measure Information:
Title
Improvement in laryngeal view
Description
Expected improvement in laryngeal view obtained with the use of Vie-Scope laryngoscope
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
intubation efficiency
Description
Success of intubation using Vie-Scope laryngoscope
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: morbid obesity BMI>40 kg/m2 scheduled for elective bariatric procedure no anatomy abnormalities of upper airway Exclusion Criteria: lack of conscent predicted difficult intubation
Facility Information:
Facility Name
Medical University of Lodz, Poland
City
Łódź
ZIP/Postal Code
90-153
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Comparison of Vie-Scope and Macintosh Blade Laryngoscopes in Morbidly Obese.

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