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NCT Number: NCT05502120

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

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Lodz, Poland

Lodz, 90-153, Poland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laryngoscopy with Vie-Scope laryngoscope

Device

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

Laryngoscopy with Macintosh blade laryngoscope

Device

Evaluation of laryngeal view using stnadard Macintosh blade laryngoscope

Primary outcomes

  1. 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

Secondary outcomes

  1. intubation efficiency

    Time frame: through study completion, an average of 1 year

    Success of intubation using Vie-Scope laryngoscope

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2022
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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