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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05502120
Other study ID # RNN/49/21/KB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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