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

NCT05502120 | Completed

• 1 other identifier: RNN/49/21/KB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid; Intubation Complication

Keywords

morbid obesity; endotracheal intubation

Outcome Measures

Primary Outcomes (1)

• Improvement in laryngeal view

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

  through study completion, an average of 1 year

Secondary Outcomes (1)

• intubation efficiency

  through study completion, an average of 1 year

Study Arms (2)

Macintosh blade

ACTIVE COMPARATOR

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

Vie-Scope

EXPERIMENTAL

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

Device: Laryngoscopy with Vie-Scope laryngoscope

Interventions

Laryngoscopy with Vie-Scope laryngoscope DEVICE

Evaluation of laryngeal view using Vie-Scope laryngoscope, intubation efficacy, complications

Vie-Scope

Laryngoscopy with Macintosh blade laryngoscope DEVICE

Evaluation of laryngeal view using stnadard Macintosh blade laryngoscope

Macintosh blade

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• lack of conscent
• predicted difficult intubation

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Medical University of Lodz, Poland

Lodz, 90-153, Poland

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Laryngoscopy

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: August 16, 2022
• Study Start: September 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)