Non-inferiority Trial Comparing visionPRO to Glidescope Video Laryngoscopes

November 4, 2024 updated by: Ruediger Noppens, Lawson Health Research Institute

Pilot Study Comparing the HEINE visionPRO HyMac 3 and the GlideScope Hyperangulated S3 Laryngoscope Blade on Time to Intubation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial is a single-centre, pilot, patient-blinded, randomized controlled non-inferiority trial.

Patients who decide to participate in this study will have their surgery and follow up care proceed according to standard of care. Video laryngoscopy is standard of care for this patient population at LHSC. Once eligibility is confirmed and informed, written consent has been obtained, participants be randomized to one of two study groups:

  1. Laryngoscopy performed using the Glidescope device (Verathon Inc., Bothell, USA)
  2. Laryngoscopy performed using the visionPRO device (HEINE® Optotechnick, Gilching, Germany)

Surgery, anesthetic management, and intubation protocol will proceed according to standard of care.

(A) All patients are observed for ECG, oxygen saturation (SpO2), and non-invasive blood pressure. Pre-oxygenation is carried out by the provider based on patient characteristics and standard clinical procedures (EtO2 > 80%).

(B) After adequate pre-oxygenation, anaesthesia is initiated using a combination of fentanyl (0.1 - 0.15 µg.kg-1) / sufentanil (0.2 - 0.5 µg.kg-1), and propofol (2 - 3 mg.kg-1), with the choice of drugs and dosages tailored to the specific needs of the patient. Maintenance is achieved either through propofol infusion (TIVA) or inhaled anaesthetics. The selection of a neuromuscular blocking agent is based on the surgery's duration, the need for perioperative neurological monitoring, and the absence of allergies and organ failures. The agents and their dosages used are:

  1. Rocuronium (0.5 - 1.2 mg.kg-1); and
  2. Succinylcholine (1 - 2 mg.kg-1).

The train-of-four (TOF) method is employed by the study nurse for continuous quantitative monitoring of neuromuscular transmission. Complete muscle relaxation is confirmed by the absence of tactile and measured twitches in response to maximal TOF stimulation of the ulnar nerve at the adductor pollicis. Study personnel were instructed on the importance of achieving adequate neuromuscular blockade.

(C) The laryngoscopy attempt starts with a TOF count of 0/4, using the device specified by randomization:

  1. visionPRO (HEINE® Optotechnick, Gilching, Germany) or
  2. GlideScope (Verathon Inc., Bothell, USA)

The provider aims to achieve the clearest view of the laryngeal structures. External laryngeal manipulations (ELM) may be employed to enhance the view of the glottis, aiming for a Cormack and Lehane grade I or II. The endotracheal tube size and blade size are chosen according to the hospital's standard operating procedures (blade size: #3 for average patients, #4 for taller patients; standard ET sizes: 7.0-7.5 ID for female patients and 7.5-8.0 ID for male patients). The method of glottic visualization and the size of the ET and blade are documented in the case report form (CRF).

(D) An intubation attempt is defined as the insertion and removal of the laryngoscope blade from the mouth, regardless of ET insertion success. A laryngoscopy attempt is considered successful if the tracheal tube is placed with a single blade insertion within 120 seconds and without manipulation of the laryngoscope by another provider. The following times periods until final ET placement are measured by a study nurse via a timer:

  1. "Time to intubation": duration from the opening of the patient's mouth to the passage of the ET through the vocal cords.
  2. "Time to view": the time from device insertion to visualization of the glottis;
  3. "Time to ventilation": the time from device insertion into the mouth until confirmation of the first CO2 wave on the anaesthesia respirator.

If the first attempt fails, the provider makes a second attempt with the same device, with mask ventilation recommended between attempts. A maximum of two laryngoscopy attempts are allowed. After two attempts the clinician switches to a preferred technique and records the direct and/or screen view. If this preferred technique fails after two attempts, the clinician proceeds with a preferred rescue technique. The study protocol recommends this limit of two intubation attempts and alternative technique selection in line with clinical standards. If ELM techniques, such as BURP (specific pressure applied to the cricoid cartilage), are needed during laryngoscopy, they are documented in the CRF. Throughout the induction of anaesthesia, a study nurse not involved in patient care records the study parameters.

24 hours following surgery, the patient will be assessed for presence and severity of sore throat rated on a scale of 0-3 (0 meaning no sore throat and 3 meaning severe sore throat), hoarseness rated on a scale of 0-3 (0 meaning no complaint and 3 meaning severe hoarseness), and cough rated on a scale of 0-3 (0 meaning no cough and 3 meaning severe cough).

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video laryngoscopy with visionPRO
Video laryngoscopy will be performed with the visionPRO (HEINE® Optotechnick, Gilching, Germany)
Device: Video laryngoscopy with visionPRO
Video laryngoscopy to be performed using the visionPRO (HEINE® Optotechnick, Gilching, Germany) during intubation.
Active Comparator: Video laryngoscopy with Glidescope
Video laryngoscopy will be performed with the GlideScope (Verathon Inc., Bothell, USA)
Device: Video laryngoscopy with Glidescope
Video laryngoscopy to be performed using theGlideScope (Verathon Inc., Bothell, USA) during intubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial or first-pass success rate of indirect video laryngoscope endotracheal intubation (ET)
Time Frame: 0-120 seconds for first pass intubation attempt.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of patient-reported postoperative sore throat (POST) during the first 24 hours
Time Frame: 24 hours following surgery
The secondary outcome compares the incidence and severity of patient-reported postoperative sore throat (POST) during the first 24 hours. This will be measured by asking patients to rate any occurrence of sore throat on a scale of 0-3 (0 meaning no sore throat and 3 meaning severe sore throat) 24 hours following surgery
24 hours following surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timing of tracheal intubation events
Time Frame: Duration of intubation procedure
  1. "Time to intubation": duration from the opening of the patient's mouth to the passage of the ET through the vocal cords.
  2. "Time to view": the time from device insertion to visualization of the glottis.
  3. "Time to ventilation": the time from device insertion into the mouth until confirmation of the first CO2 wave on the anaesthesia respirator.

Measured by recording intubation observations and details during surgery.
Duration of intubation procedure
Number of laryngoscopy attempts
Time Frame: Duration of intubation procedure
Number of laryngoscopy attempts required to achieve successful intubation. Measured by recording the number of intubation attempts needed before procedure is successfully executed.
Duration of intubation procedure
Number of additional operators
Time Frame: Duration of intubation procedure

Number of operators required to facilitate successful intubation.

Measured by recording the operators that needed to be involved before procedure is successfully executed.
Duration of intubation procedure
Lifting force required
Time Frame: Duration of intubation procedure

Lifting force required (normal or increased) to facilitate successful intubation.

Measured by recording the physical effort required during laryngoscopy.
Duration of intubation procedure
Failures/crossovers to other rescue techniques
Time Frame: Duration of intubation procedure

Instances that intubation failed, required use of other techniques/devices other than the study group (laryngoscopy with either the visionPRO or Glidscope device) the participant was randomized to, or required rescue technique to successfully intubate the patient.

Measured by recording intubation observations and details during surgery.
Duration of intubation procedure
Use of extra laryngeal manipulation
Time Frame: Duration of intubation procedure
Use of extra laryngeal manipulation (applied or not applied) required to complete successful intubation. Measured by recording intubation observations and details during surgery.
Duration of intubation procedure
Visualization of glottic view
Time Frame: Duration of intubation procedure
Assessment of glottic view using Cormack and Lehane grading and percentage of glottic opening (POGO) score.
Duration of intubation procedure
Intubation difficulty
Time Frame: Completion of intubation procedure
Difficulty of intubation will be assessed using the Intubation Difficulty Score.
Completion of intubation procedure
Correlation between clinical experiences in airway management and level of training with success rates
Time Frame: Duration of intubation procedure
Intubation success rates will be correlated to operator experience in anesthesia (consultant or resident and years holding each designation) and experience each operator had performing video laryngoscopy, and comparing this to the details of their intubation attempts.
Duration of intubation procedure
Complications
Time Frame: Time of surgery to 24 hours postoperative
Complications for each participant, if applicable (such as desaturation, dental injury, lip injury, glottis injury, other) will be recorded to determine if there is a correlation between complications and video laryngoscope used (visionPRO or Glidescope).
Time of surgery to 24 hours postoperative
Degree of ease or difficulty of tracheal intubation
Time Frame: Duration of intubation procedure
Degree of ease or difficulty of tracheal intubation will be measured using a Likert scale (0=easy to 10=difficult) to assess operator-reported difficulty using the video laryngoscopes.
Duration of intubation procedure
Position of the vocal chords
Time Frame: Duration of intubation procedure
Positioning of the vocal cords (abducted or adducted) will be assess for each intubation performed.
Duration of intubation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Ruediger Noppens, Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • visionPRO vs. Glidescope

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Airway Management

Clinical Trials on Video laryngoscopy with visionPRO

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe