SuprAglottic superImposed High Frequency Jet Ventilation veRsus High-flow nAsal oxYgen in Tubeless Laryngotracheal Surgery (AIRWAY): a Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Overall number of cases without interruptions
研究概览
简要总结
This study aims to investigate two oxygenation methods (high flow nasal oxygen and supraglottic, superimposed high-frequency jet ventilation) for tubeless laryngotracheal surgeries concerning their safety and efficiency.
详细描述
Eligible adult patients will be prepared for intubation according to the local SOPs of the anesthesia departments. Mandatory monitoring will consist of: SpO2, HR, NIBP, tcCO2, EEG, TOF and EIT.
Induction of anesthesia: Patients will be preoxygenated before induction of anesthesia for at least one minute through face-mask with FiO2 1.0 until etO2 reaches 0.9. The induction of anesthesia will be performed using a combination of sedative/hypnotic drugs, opioids and muscle relaxant.
The following medications will be mandatory as per protocol:
- A neuromuscular blocking agent (NMBA): Rocuronium 0.5-1 mg/kg
- Propofol 1-3 mg/kg
- Opioid: Fentanyl 1-3mcg/kg, Remifentanyl 1-3mcg/kg
After induction of anesthesia and the administration of a NMBA, bag-mask ventilation with FiO2 1.0 will be performed for at least 60 seconds or until the muscle relaxant is working. Full neuromuscular blockade will be assessed by train-of-four (TOF) monitoring. Anaesthesia will be given total intravenously with Propofol and Remifentanil under EEG guidance. Tracheal tube will be placed recruitment manoeuver (RM) will be performed before surgical disinfection. The RM consists of recruitment pressure of 30 cmH2O during 30 seconds. PEEP level will be set at 10cmH20.
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
- Single (Participant)
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
- •Written informed consent
- •Patients aged ≥18 years
- •Patients requiring elective tubeless laryngotracheal surgery
排除标准
- •Patients <18 years
- •High risk of aspiration which concludes the consideration of using a tube in order to prevent aspiration.
研究组 & 干预措施
Intervention group
Supraglottic, superimposed high frequency jet ventilation using the TwinStream EVO (Carl Reiner GmbH, Vienna, Austria) with initial 1.0 FiO2 reduced to 0.3 during laser surgery
干预措施: supraglottic superimposed high frequency jet ventilation ventilation using the TwinStream EVO (Carl Reiner GmbH, Vienna, Austria) (Device)
Control group
high-flow oxygen (up to 70 L/min FiO2 1.0) via nasal cannula with the Optiflow (Fisher & Paykel Healthcare, Auckland, New Zealand) with initial 1.0 FiO2 reduced to 0.3 during laser surgery
干预措施: High-flow nasal supplemental oxygen via nasal cannula with the Optiflow (Fisher & Paykel, Auckland, New Zealand) (Device)
结局指标
主要结局
Overall number of cases without interruptions
时间窗: 2 hours
Number of cases using SSHFJV vs HFNO without interruption of the surgical procedure for rescue, during tubeless laryngo-tracheal surgery from placement of the laryngoscope to end of surgery.
次要结局
- Value of oxygen level(5 minutes)
- Number of interruptions(5 minutes)
- Reason for change of airway strategy(5 minutes)
- Time until desaturation(2 hours)
- Duration of interruptions(15 minutes)
- Overall anesthesia time(3 hours)
- Duration of desaturation(5 minutes)
- Overall surgery time(2 hours)
- Duration of hypercapnia(5 minutes)
- Value of carbon dioxide level(5 minutes)
- Respiratory complications(24 hours)
- End-expiratory lung impedance (EELI) after the end of induction before the surgical procedure.(1 hour)
- End-expiratory lung impedance (EELI) at the end of the surgical procedure.(3 hours)
- End-expiratory lung impedance (EELI) after the end of anaesthesia.(3 hours)
- End-expiratory lung impedance (EELI) before discharge of PACU.(5 hours)
- Changes in silent spaces after the end of induction before the surgical procedure.(1 hour)
- Changes in silent spaces after the end of anaesthesia.(3 hours)
- Changes in silent spaces at the end of the surgical procedure.(3 hours)
- Changes in silent spaces before discharge of PACU.(5 hours)
- Ventilation inhomogeneity after the end of anaesthesia.(3 hours)
- Ventilation inhomogeneity before discharge of PACU.(5 hours)
- Ventilation inhomogeneity after the end of induction before the surgical procedure.(1 hour)