Effect of Modified Endotracheal Intubation Protocol Combined With Early Oral Intake on Postoperative Recovery Quality in Thyroid and Parathyroid Surgery at a Tertiary Hospital in China: A 2x2 Factorial Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Quality of Recovery-15 score on the first day after surgery
研究概览
简要总结
The purpose of this study is to assess the effect of modified endotracheal intubation procedure combined with early oral intake on postoperative recovery quality of patients, so as to further optimize the ERAS（enhanced recovery after surgery） program for thyroid or parathyroid surgery.
详细描述
After being informed about the study and potential risk, all patients giving written informed consent will undergo a screening-period to determine eligibility for study entry. Before operation, patients will be randomly assigned to conventional intubation process group or modified intubation process group before the operation. After the operation, patients will enter the PACU（post-anaesthesia care unit） for further observation. When the anesthesiologists and surgeons agree that patients have no early oral drinking high-risk factors, patients will be randomly assigned to early resumption of oral intake group or late resumption of oral intake group for further observation and evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The questionnaire collectors and outcomes assessor will not be informed of the group of patients
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
- •American Society of Anesthesiologists (ASA) physical status classification I-II
- •Body mass index 18.5-29.9kg/m2
- •First operation on operation day
排除标准
- •Patients or family members cannot understand the conditions and objectives of this study
- •Preoperative patients with acute pharyngitis, hoarseness, cough, dysphagia, and high risk of aspiration
- •The surgeons or anesthesiologists point out that the patient is not suitable for early postoperative drinking (such as considering the injury of recurrent laryngeal nerve or lymphatic vessels during the operation)
- •Patients who cannot be intubated under visual laryngoscope(such as difficult airway, loose incisors and so on)
- •Exclusion criteria of Quality of Recovery-15* (*Quality of Recovery-15 exclusion criteria:
- •Unable to understand words and language;
- •Difficult to cooperate due to mental disorders;
- •History of alcohol or drug abuse;
- •Any serious pre-existing medical condition that can limit the objective evaluation after surgery;
- •Any life-threatening complications;
- •Emergency surgery)
结局指标
主要结局
Quality of Recovery-15 score on the first day after surgery
时间窗: one day
Using Quality of Recovery-15 questionnaire to evaluate the quality of perioperative recovery. Quality of Recovery-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score is the Quality of Recovery-15 score of the patient.
次要结局
- Patient satisfaction(through patient discharge, an average of 2-3 days after surgery)
- Quality of Recovery-15 score on the day of discharge(one day)
- Postoperative hospital stay length(through patient discharge, an average of 2-3 days after surgery)
- Drainage volume(through removal of drainage tube, an average of 2 days after surgery)
- Adverse event(through patient discharge, an average of 2-3 days after surgery)
- Postoperative pain(one day)
- Postoperative patient discomfort(one day)
- Intubation time(one day)
- Endotracheal tube readjustment rate(one day)
- Postoperative nausea and vomiting(through patient discharge, an average of 2-3 days after surgery)
- Gastrointestinal recovery time(through exhaustion after surgery, an average of 1-2 days after surgery)