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

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05502120
• Other study ID #: RNN/49/21/KB
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: June 2022
• Source: Medical University of Lodz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation Complication
• Obesity, Morbid

Intervention

Device:
• Laryngoscopy with Vie-Scope laryngoscope
Evaluation of laryngeal view using Vie-Scope laryngoscope, intubation efficacy, complications
• Laryngoscopy with Macintosh blade laryngoscope
Evaluation of laryngeal view using stnadard Macintosh blade laryngoscope

Locations

Country	Name	City	State
Poland	Medical University of Lodz, Poland	Lódz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	intubation efficiency	Success of intubation using Vie-Scope laryngoscope	through study completion, an average of 1 year