First Randomised Controlled Clinical Evaluation of the Impact of Anti-Aerosol VACCIN Box on the Videolaryngoscopic Intubation Procedure
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Intubation time
研究概览
简要总结
The VACCIN box, an anti-aerosol intubation box for potential use on COVID-19 (SARS-CoV-2) positive patients, was designed in order to reduce the transmission risk to healthcare workers. This study will compare the safety and the ease of use of the VACCIN box to a standard intubation in healthy participants undergoing elective surgery. It is expected that intubation times and success rate of intubation in the same circumstances will be similar with and without the use of the VACCIN box.
详细描述
Novel ways to protect healthcare workers were developed around the world in the setting of the COVID-19 (SARS-CoV-2) pandemic. Shortage of personal protective equipment (PPE) and concern of potential viral transmission during aerosol generating procedures such as endotracheal intubation fueled the emergence of intubation boxes. However, a lack of details about their safety and efficiency remains.
This study will evaluate safety and ease of use of the VACCIN box in participants undergoing elective surgery requiring endotracheal intubation. The study design is a prospective randomized single center clinical trial comparing intubation with and without its use. It is expected that intubation times and success rate of intubation in the same circumstances will be similar with and without the use of the VACCIN box. Eligible participants will be randomized in a 1:1 ratio after informed consent.
Participants in both groups will be intubated in the same circumstances. The procedure include a midazolam anxiolysis, a rapid sequence induction without cricoid pressure of predefined dosing of remifentanil, propofol and rocuronium and monitoring of an adequate muscles paralysis and dept of anesthesia.
Anesthesiologists will intubate in both groups using specific material: McGRATH videolaryngoscope with X-Blade, 8 mm endotracheal tube (ETT) for men or 7 mm for women and the Glidescope videolaryngoscope stylet inside the ETT.
The experimental group will differ from the control group by application of the VACCIN box over the participant's head through which the anesthesiologist will intubate. Proper installation and removal of the VACCIN box will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective surgery requiring general anesthesia with tracheal intubation
- •ASA status I, II or III
- •Good understanding of English or French
排除标准
- •Known difficult airway
- •Anticipated difficult airway (Mallampati ≥ 3, oral opening < 2.5 cm, thyromental distance < 6 cm, limited cervical mobility, significant abnormality of the upper respiratory tract, history of major surgery on airway or cervical area)
- •COVID-19 positive or unknown status
- •Rapid sequence contraindication
- •Presence of antibiotic-resistant bacteria requiring a form of additional protective equipment
- •Claustrophobia
- •Chronic anxiety
- •Allergy or intolerance to any of the study drugs
- •Emergent surgery
- •Pregnancy
- •Preoperative hemodynamic disturbance
- •Patient refusal
结局指标
主要结局
Intubation time
时间窗: Intubation time will correspond to the time interval in seconds between the preoxygenation face mask removal and the detection of end-tidal CO2 on the anesthesia monitor
Seconds
次要结局
- Success rate of intubation at first laryngoscopy(Immediately after the intubation)
- Breach of air tightness(Immediately after the intubation)
- Qualitative reviews on intubation with the VACCIN box(Immediately after the intubation)
- Heart rate variations around tracheal intubation(before, during and for 5 minutes after tracheal intubation)
- NOL variation (NOL is an index without unit) around tracheal intubation(before, during and for 5 minutes after tracheal intubation)
- Bispectral index (BIS) variation (BIS is an index without unit) around tracheal intubation(before, during and for 5 minutes after tracheal intubation)
- Ease of tracheal intubation(Immediately after the intubation)
- VACCIN box installation time(The VACCIN box installation time will correspond to the time interval in the experimental group between the start of the VACCIN box placement over the participant's head to the removal of the preoxygenation mask before intubation.)
- VACCIN box removal time(The VACCIN box removal time will correspond to the time interval in the experimental group between the initial detection of end-tidal CO2 on the anesthesia monitor to the complete removal of the VACCIN box.)
- Non-invasive blood pressure variations around tracheal intubation(before, during and for 5 minutes after tracheal intubation)
研究者
Issam TANOUBI
MD, MA(ed), Associate Professor
Maisonneuve-Rosemont Hospital