About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Having elective surgery with general anesthesia
At least 18 years of age
requiring mechanical ventilation via an oral endotracheal tube
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Video laryngoscopy with visionPRO
DeviceVideo laryngoscopy to be performed using the visionPRO (HEINE® Optotechnick, Gilching, Germany) during intubation.
Video laryngoscopy with Glidescope
DeviceVideo laryngoscopy to be performed using theGlideScope (Verathon Inc., Bothell, USA) during intubation.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
Other outcomes
Timing of tracheal intubation events
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.
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.
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.
Lifting force required
Lifting force required (normal or increased) to facilitate successful intubation. Measured by recording the physical effort required during laryngoscopy.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: