Non-inferiority Trial Comparing visionPRO to Glidescope Video Laryngoscopes

NCT06676462 | Not Yet Recruiting

• 1 other identifier: visionPRO vs. Glidescope
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Indirect video laryngoscope tracheal intubation with the GlideScope (Verathon Inc., Bothell, USA) has become a well-established technique in emergency and clinical anaesthesia, offering first-pass intubation success rates comparable to those achieved with direct laryngoscopy. Different video laryngoscopes vary significantly in design, including blade shape, mobility, and camera operation, which can affect patient outcomes. Two video laryngoscopes with hyperangulated blades include the GlideScope (Verathon Inc., Bothell, USA) and the visionPRO (HEINE® Optotechnick, Gilching, Germany). The Glidescope comprises an external monitor connected to a medical-grade plastic handle which is compatible with reusable and disposable blades. The newer visionPro comprises a reusable anodized aluminum integrated monitor that is attached to the camera/handle which is compatible with disposable blades. The hyperangulated blade of the VisionPro is a unique combination of previously designed laryngoscope blades meant to increase performance. The introduction of this new hyperangulated blade design in the VisionPro raises the need to compare its performance against the established GlideScope. The aim of this pilot study is to generate initial data to evaluate whether the use of the visionPRO (HEINE® Optotechnick, Gilching, Germany) provides a non-inferior first-pass success rate compared with the GlideScope (Verathon Inc., Bothell, USA) in surgical patients with an expected normal airway undergoing general anaesthesia The investigators hypothesize that tracheal intubation using the HEINE visionPRO will achieve a similar frequency of failed intubation and airway complications. This study plans to recruit 100 patients.

Conditions

Intubation; Difficult or Failed; Intubation Complication; Video Laryngoscopy; Airway Management

Outcome Measures

Primary Outcomes (1)

• Initial or first-pass success rate of indirect video laryngoscope endotracheal intubation (ET)

  The primary outcome compares the initial or first-pass success rate of indirect video laryngoscope endotracheal intubation (ET) with the HyMac blade of the visionPRO (HEINE® Optotechnick, Gilching, Germany) to the hyperangulated blade of the GlideScope (Verathon Inc., Bothell, USA) in patients undergoing elective surgery and requiring tracheal intubation. This will be measured by recording how long it takes for successful intubation to take place using the above-mentioned devices, and any complications that may have arisen during the intubation procedure.

  0-120 seconds for first pass intubation attempt.

Secondary Outcomes (1)

• Incidence and severity of patient-reported postoperative sore throat (POST) during the first 24 hours

  24 hours following surgery

Other Outcomes (12)

• Timing of tracheal intubation events

  Duration of intubation procedure

• Number of laryngoscopy attempts

  Duration of intubation procedure

• Number of additional operators

  Duration of intubation procedure

Study Arms (2)

Video laryngoscopy with visionPRO

EXPERIMENTAL

Video laryngoscopy will be performed with the visionPRO (HEINE® Optotechnick, Gilching, Germany)

Device: Video laryngoscopy with visionPRO

Video laryngoscopy with Glidescope

ACTIVE COMPARATOR

Video laryngoscopy will be performed with the GlideScope (Verathon Inc., Bothell, USA)

Device: Video laryngoscopy with Glidescope

Interventions

Video laryngoscopy with visionPRO DEVICE

Video laryngoscopy to be performed using the visionPRO (HEINE® Optotechnick, Gilching, Germany) during intubation.

Video laryngoscopy with visionPRO

Video laryngoscopy with Glidescope DEVICE

Video laryngoscopy to be performed using theGlideScope (Verathon Inc., Bothell, USA) during intubation.

Video laryngoscopy with Glidescope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having elective surgery with general anesthesia
• At least 18 years of age
• requiring mechanical ventilation via an oral endotracheal tube

You may not qualify if:

• More than one predictor of an anticipated difficult airway (eg, body mass index (BMI) \>40 kg/m2, unanticipated difficult airway in the medical history (eg, Cormack \& Lehane (C\&L) ≥III), reduction of the atlanto-occipital joint extension \<35°, reduced thyromental distance \<6 cm or Mallampati class ≥III)
• Age \<18 years
• ASA class IV-VI
• Pregnant or breastfeeding
• Unable to provide informed written consent or under guardianship
• Urgent surgical intervention
• At high risk for aspiration
• Patients undergoing any neck and throat surgery.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Related Publications (33)

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Study Officials

• Ruediger Noppens

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruediger Noppens, MD

CONTACT

5196858500; ruediger.noppens@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Associate Professor

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share