A Comparison of Vie-Scope and Macintosh Blade Laryngoscopes in Morbidly Obese.
Primary Purpose
Obesity, Morbid, Intubation Complication
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Laryngoscopy with Vie-Scope laryngoscope
Laryngoscopy with Macintosh blade laryngoscope
Sponsored by
About this trial
This is an interventional other trial for Obesity, Morbid focused on measuring morbid obesity, endotracheal intubation
Eligibility Criteria
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
Sites / Locations
- Medical University of Lodz, Poland
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Macintosh blade
Vie-Scope
Arm Description
Visualisation of entrance to larynx using Standard Macintosh blade laryngoscope followed by Visualisation of entrance to larynx using Vie-Scope laryngoscope
Visualisation of entrance to larynx using Vie-Scope laryngoscope after visualisation using Macintosh blade laryngoscope
Outcomes
Primary Outcome Measures
Improvement in laryngeal view
Expected improvement in laryngeal view obtained with the use of Vie-Scope laryngoscope
Secondary Outcome Measures
intubation efficiency
Success of intubation using Vie-Scope laryngoscope
Full Information
NCT ID
NCT05502120
First Posted
June 22, 2022
Last Updated
August 12, 2022
Sponsor
Medical University of Lodz
1. Study Identification
Unique Protocol Identification Number
NCT05502120
Brief Title
A Comparison of Vie-Scope and Macintosh Blade Laryngoscopes in Morbidly Obese.
Official Title
A Comparison of Visualization of the Larynx With the Vie Scope Versus Standard Macintosh Laryngoscope in Morbidly Obese Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Lodz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Intubation Complication
Keywords
morbid obesity, endotracheal intubation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Macintosh blade
Arm Type
Active Comparator
Arm Description
Visualisation of entrance to larynx using Standard Macintosh blade laryngoscope followed by Visualisation of entrance to larynx using Vie-Scope laryngoscope
Arm Title
Vie-Scope
Arm Type
Experimental
Arm Description
Visualisation of entrance to larynx using Vie-Scope laryngoscope after visualisation using Macintosh blade laryngoscope
Intervention Type
Device
Intervention Name(s)
Laryngoscopy with Vie-Scope laryngoscope
Intervention Description
Evaluation of laryngeal view using Vie-Scope laryngoscope, intubation efficacy, complications
Intervention Type
Device
Intervention Name(s)
Laryngoscopy with Macintosh blade laryngoscope
Intervention Description
Evaluation of laryngeal view using stnadard Macintosh blade laryngoscope
Primary Outcome Measure Information:
Title
Improvement in laryngeal view
Description
Expected improvement in laryngeal view obtained with the use of Vie-Scope laryngoscope
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
intubation efficiency
Description
Success of intubation using Vie-Scope laryngoscope
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical University of Lodz, Poland
City
Łódź
ZIP/Postal Code
90-153
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Comparison of Vie-Scope and Macintosh Blade Laryngoscopes in Morbidly Obese.
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