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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.
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:
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:
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:
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video laryngoscopy with visionPRO | Experimental | Video laryngoscopy will be performed with the visionPRO (HEINE® Optotechnick, Gilching, Germany) |
|
| Video laryngoscopy with Glidescope | Active Comparator | Video laryngoscopy will be performed with the GlideScope (Verathon Inc., Bothell, USA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video laryngoscopy with visionPRO | Device | Video laryngoscopy to be performed using the visionPRO (HEINE® Optotechnick, Gilching, Germany) during intubation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of patient-reported postoperative sore throat (POST) during the first 24 hours | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Timing of tracheal intubation events |
Measured by recording intubation observations and details during surgery. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruediger Noppens, MD | Contact | 5196858500 | 13707 | ruediger.noppens@lhsc.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Ruediger Noppens | Western University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36928625 | Background | Kriege M, Noppens RR, Turkstra T, Payne S, Kunitz O, Tzanova I, Schmidtmann I; EMMA Trial Investigators Group. A multicentre randomised controlled trial of the McGrath Mac videolaryngoscope versus conventional laryngoscopy. Anaesthesia. 2023 Jun;78(6):722-729. doi: 10.1111/anae.15985. Epub 2023 Mar 16. | |
| 23823612 | Background |
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| Video laryngoscopy with Glidescope | Device | Video laryngoscopy to be performed using theGlideScope (Verathon Inc., Bothell, USA) during intubation. |
|
| 24 hours following surgery |
| Duration of intubation procedure |
| Number of laryngoscopy attempts | 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 | 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 | 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 | 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 | 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 | Assessment of glottic view using Cormack and Lehane grading and percentage of glottic opening (POGO) score. | Duration of intubation procedure |
| Intubation difficulty | 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 | 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 | 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 | 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 | Positioning of the vocal cords (abducted or adducted) will be assess for each intubation performed. | Duration of intubation procedure |
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