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

August 12, 2022 updated by: Medical University of Lodz

A Comparison of Visualization of the Larynx With the Vie Scope Versus Standard Macintosh Laryngoscope in Morbidly Obese Patients.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Łódź, Poland, 90-153
        • Medical University of Lodz, Poland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Macintosh blade
Visualisation of entrance to larynx using Standard Macintosh blade laryngoscope followed by Visualisation of entrance to larynx using Vie-Scope laryngoscope
Device: Laryngoscopy with Macintosh blade laryngoscope
Evaluation of laryngeal view using stnadard Macintosh blade laryngoscope
Experimental: Vie-Scope
Visualisation of entrance to larynx using Vie-Scope laryngoscope after visualisation using Macintosh blade laryngoscope
Device: Laryngoscopy with Vie-Scope laryngoscope
Evaluation of laryngeal view using Vie-Scope laryngoscope, intubation efficacy, complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in laryngeal view
Time Frame: through study completion, an average of 1 year
Expected improvement in laryngeal view obtained with the use of Vie-Scope laryngoscope
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intubation efficiency
Time Frame: through study completion, an average of 1 year
Success of intubation using Vie-Scope laryngoscope
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

August 12, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNN/49/21/KB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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