Pressure Supporting Ventilation and Electroencephalography-guided Extubation for Free of Unwanted compLications (PEACEFUL): a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Lowest SpO2 after emergence
研究概览
简要总结
This study aims to assess whether pressure supporting ventilation and electroencephalogram (EEG)-guided emergence can reduce airway complications after thyroid surgery compared with conventional emergence. Patients will be randomly assigned to either pressure supporting ventilation and EEG-guided emergence group (intervention group) or conventional emergence group (control group). Co-primary outcomes are the incidence of emergence coughing and lowest percutaneous oxygen saturation (SpO2) after emergence. Secondary outcomes included severity of emergence cough, emergence time, blood pressure and heart rate during emergence, Richmond Agitation-Sedation Scale (RASS) immediately after extubation and upon post-anesthesia care unit (PACU) arrival, incidence of desaturation during PACU stay, hoarseness, sore throat during PACU stay, duration of PACU stay, surgeon satisfaction regarding emergence process, postoperative pain score, and patient satisfaction score regarding emergence process.
详细描述
Adult patients aged < 40 years scheduled to undergo thyroid surgery will be screened for eligibility. Patients will be randomly allocate to either the intervention group or control group.
- In the intervention group, pressure support ventilation will be applied from the start of subcutaneous suture until extubation. At the end of surgery, sevoflurane will be discontinued, and the attending anesthesiologist will perform tracheal extubation after observing the 'zipper opening' pattern on the EEG spectrogram, indicating the patient's recovery of consciousness. For safety reason, extubation will also be guided by the following processed EEG indices thresholds:
- 95% spectral edge frequency (SEF) ≥ 23
- Patient state index (PSI) ≥ 64
- In the control group, conventional full-awake extubation will be performed based on the routine practice of our institution. At the end of surgery, sevoflurane will be stopped, and the attending anesthesiologist will lead the emergence process, allowing the patient to breathe spontaneously and providing intermittent manual assistance if necessary. Extubation will be performed when the patient meets the following criteria: obeys commands such as eye-opening or hand-grip, tidal volume > 5 ml/kg, end-tidal carbon dioxide < 45 mmHg, spontaneous respiratory rate 10 to 20 breaths/min.
In both groups, the Oxygen Reserve Index (ORi) will be monitored. Blinded investigator will assess the incidence of emergence coughing and the lowest SpO2 after emergence.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Patients, medical staff responsible for measuring outcome variables, surgeons, and nurses in the recovery room and wards will be blinded. This blinding approach ensures that both medical staff and patients remain unaware of the assigned group throughout the study.
入排标准
- 年龄范围
- 19 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged under 40 years who are scheduled to undergo thyroid surgery.
排除标准
- •Patients scheduled for radical neck dissection
- •Patients scheduled for lymph node biopsy
- •Patients with an anticipated difficult airway
- •Patients experiencing difficulty during intubation
- •Patients with a fasting time not meeting institutional policy
- •Patients with a body mass index (BMI) greater than 30 kg/m²
- •Patients with sleep apnea
- •Pregnant or breastfeeding women
- •Patients unable to communicate
结局指标
主要结局
Lowest SpO2 after emergence
时间窗: During the time period from sevoflurane cessation until post-anesthesia care unit (PACU) discharge, an average of 1 hour
Lowest SpO2 after emergence (defined as the lowest SpO2 value during the time period from sevoflurane off to post-anesthesia care unit (PACU) discharge)
Incidence of emergence coughing
时间窗: During the time period from sevoflurane cessation until 5 minutes after extubation
Incidence of emergence coughing (defined as coughing during the time period from sevoflurane off until 5 minutes after extubation)
次要结局
- Incidence and severity of coughing during PACU stay(During the time period from PACU admission until PACU discharge, an average of 40 minutes)
- Time to leave operating room(During the time period from sevoflurane cessation until leaving operating room, an average of 30 minutes)
- Incidence and severity of sore throat(During the time period from PACU admission until PACU discharge, an average of 40 minutes)
- Emergence time(During the time period from sevoflurane cessation until tracheal extubation, an average of 20 minutes)
- Severity of Emergence coughing(During the time period from sevoflurane cessation until 5 minutes after extubation.)
- Richmond Agitation-Sedation Scale (RASS) immediately after extubation and upon PACU arrival(RASS will be assessed at two time points; (1) immediately after tracheal extubation, and (2) immediately after PACU arrival)
- Patient satisfaction score regarding emergence process(During the time period from PACU admission until PACU discharge, an average of 40 minutes)
- Blood pressure during emergence(during the time period from sevoflurane off until 5 minutes after extubation)
- Heart rate during emergence(during the time period from sevoflurane off until 5 minutes after extubation)
- Incidence of endotracheal tube biting(During the time period from sevoflurane cessation until tracheal extubation, an average of 20 minutes)
- Hypoventilation after extubation (RR <8/min)(During the time period from PACU admission until PACU discharge, an average of 40 minutes)
- Duration of PACU stay(During the time period from PACU admission until PACU discharge, an average of 40 minutes)
- Surgeon satisfaction regarding emergence process encompassing smoothness/safety/speed(Immediately after the transfer of the patient from operating room to PACU)
- Pain score during PACU stay(During the time period from PACU admission until PACU discharge, an average of 40 minutes)
- Incidence of desaturation during PACU stay(During the time period from PACU admission until PACU discharge, an average of 40 minutes)
- Hoarseness(During the time period from PACU admission until PACU discharge, an average of 40 minutes)
- Incidence of awareness with recall(During the time period from PACU admission until PACU discharge, an average of 40 minutes)
- reoperation(After operation, through the hospitalization, an average of 3 days.)
- Incidence of Postoperative hematoma(After operation, through the hospitalization, an average of 3 days.)
- Incidence of wound dehiscence(After operation, through the hospitalization, an average of 3 days.)
- Oxygen Reserve Index(During the period from sevoflurane cessation until PACU discharge, an average of 1 hour)
研究者
Young Song
Associcate Professor
Gangnam Severance Hospital