Pilot Study Comparing the HEINE visionPRO HyMac 3 and the GlideScope Hyperangulated S3 Laryngoscope Blade on Time to Intubation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Initial or first-pass success rate of indirect video laryngoscope endotracheal intubation (ET)
研究概览
简要总结
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.
详细描述
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:
- Laryngoscopy performed using the Glidescope device (Verathon Inc., Bothell, USA)
- 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%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having elective surgery with general anesthesia
- •At least 18 years of age
- •requiring mechanical ventilation via an oral endotracheal tube
排除标准
- •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.
研究组 & 干预措施
Video laryngoscopy with visionPRO
Video laryngoscopy will be performed with the visionPRO (HEINE® Optotechnick, Gilching, Germany)
干预措施: Video laryngoscopy with visionPRO (Device)
Video laryngoscopy with Glidescope
Video laryngoscopy will be performed with the GlideScope (Verathon Inc., Bothell, USA)
干预措施: Video laryngoscopy with Glidescope (Device)
结局指标
主要结局
Initial or first-pass success rate of indirect video laryngoscope endotracheal intubation (ET)
时间窗: 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.
次要结局
- Incidence and severity of patient-reported postoperative sore throat (POST) during the first 24 hours(24 hours following surgery)
研究者
Ruediger Noppens
Anesthesiologist, Associate Professor
Lawson Health Research Institute