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

Sponsor

Medical University of Lodz (Other)

Overall Status

Completed

CT.gov ID

NCT05502120

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Morbid Intubation Complication	Device: Laryngoscopy with Vie-Scope laryngoscope Device: Laryngoscopy with Macintosh blade laryngoscope	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Actual Primary Completion Date :

Feb 1, 2022

Actual Study Completion Date :

Mar 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Improvement in laryngeal view [through study completion, an average of 1 year]
Expected improvement in laryngeal view obtained with the use of Vie-Scope laryngoscope

Secondary Outcome Measures

intubation efficiency [through study completion, an average of 1 year]
Success of intubation using Vie-Scope laryngoscope

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Lodz, Poland	Łódź		Poland	90-153

Sponsors and Collaborators

Medical University of Lodz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of Lodz

ClinicalTrials.gov Identifier:

NCT05502120

Other Study ID Numbers:

RNN/49/21/KB

First Posted:

Aug 16, 2022

Last Update Posted:

Aug 16, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Medical University of Lodz

morbid obesity

endotracheal intubation

Additional relevant MeSH terms:

Obesity, Morbid

Study Results

No Results Posted as of Aug 16, 2022