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

Not Applicable

Completed

• Conditions: Obesity, Morbid; Intubation Complication
• Interventions: Device: Laryngoscopy with Vie-Scope laryngoscope; Device: Laryngoscopy with Macintosh blade laryngoscope

• Registration Number: NCT05502120
• Lead Sponsor: Medical University of Lodz

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

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-03-01
• Status Verified: 2022-06
• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-08-12
• Last Update Submitted: 2022-08-12
• Study First Posted: 2022-08-16
• Last Update Posted: 2022-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vie-Scope	Laryngoscopy with Vie-Scope laryngoscope	Visualisation of entrance to larynx using Vie-Scope laryngoscope after visualisation using Macintosh blade laryngoscope
Macintosh blade	Laryngoscopy with Macintosh blade laryngoscope	Visualisation of entrance to larynx using Standard Macintosh blade laryngoscope followed by Visualisation of entrance to larynx using Vie-Scope laryngoscope

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
intubation efficiency	through study completion, an average of 1 year	Success of intubation using Vie-Scope laryngoscope

Trial Locations

Locations (1)

Medical University of Lodz, Poland; 🇵🇱 Łódź, Poland