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临床试验/NCT07060625
NCT07060625Enrolling By Invitation不适用

The Effect of Semi-recumbent Position on Hypoxemia During the Recovery Period of General Anesthesia After Lung Segment/Lobe Surgery: a Single Center, Prospective, Real-world Study

Shanghai Pulmonary Hospital, Shanghai, China1 个研究点 分布在 1 个国家目标入组 308 人开始时间: 2024年12月23日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
308
试验地点
1
主要终点
Incidence of post-PACU hypoxemia

研究概览

简要总结

Thoracoscopic surgery is the most common surgical approach in thoracic surgery, which reduces surgical trauma and postoperative pain compared with open thoracotomy, but postoperative complications should not be overlooked, with hypoxemia being particularly prominent. Postoperative hypoxemia is highly prevalent among patients recovering from non-cardiac surgery, accounting for over one-third of all cases. Hypoxemia impairs wound healing and leads to other severe complications such as cerebral dysfunction, arrhythmia, and myocardial ischemia, all of which adversely affect postoperative recovery. Although oxygen therapy can prevent and treat hypoxemia, many patients still experience hypoxia in the post-anesthesia care unit (PACU). Numerous studies have investigated various ventilation techniques aimed at enhancing postoperative pulmonary function, but the benefits of protective ventilation strategies may be lost during emergence from anesthesia. Several other studies also indicate that intraoperative ventilation measures do not improve postoperative pulmonary function. The lack of evidence demonstrating the efficacy of oxygen therapy or protective ventilation techniques in treating postoperative hypoxemia underscores the need to explore alternative strategies. Patient positioning during emergence from anesthesia is associated with perioperative and postoperative complications. Although no consensus exists on the optimal patient position during emergence, the supine position is often favored by anesthesiologists due to its simplicity and ease of monitoring. However, the reduced functional residual capacity associated with the supine position tends to promote airway closure and diminish gas exchange.

详细描述

Thoracoscopic surgery is the most common surgical approach in thoracic surgery, which reduces surgical trauma and postoperative pain compared with open thoracotomy, but postoperative complications should not be overlooked, with hypoxemia being particularly prominent. Postoperative hypoxemia is highly prevalent among patients recovering from non-cardiac surgery, accounting for over one-third of all cases. Hypoxemia impairs wound healing and leads to other severe complications such as cerebral dysfunction, arrhythmia, and myocardial ischemia, all of which adversely affect postoperative recovery. Although oxygen therapy can prevent and treat hypoxemia, many patients still experience hypoxia in the post-anesthesia care unit (PACU). Numerous studies have investigated various ventilation techniques aimed at enhancing postoperative pulmonary function, but the benefits of protective ventilation strategies may be lost during emergence from anesthesia. Several other studies also indicate that intraoperative ventilation measures do not improve postoperative pulmonary function. The lack of evidence demonstrating the efficacy of oxygen therapy or protective ventilation techniques in treating postoperative hypoxemia underscores the need to explore alternative strategies. Patient positioning during emergence from anesthesia is associated with perioperative and postoperative complications. Although no consensus exists on the optimal patient position during emergence, the supine position is often favored by anesthesiologists due to its simplicity and ease of monitoring. However, the reduced functional residual capacity associated with the supine position tends to promote airway closure and diminish gas exchange. In contrast, the semi-recumbent position (SRP) has been shown to increase vital capacity by 10% to 15%, enhance functional lung volume and residual capacity, and improve diaphragmatic range of motion, thereby promoting lung expansion and gas exchange. Currently, only one study has found that in patients undergoing laparoscopic-assisted upper abdominal surgery, 30° SRP during anesthesia recovery can reduce the incidence of postoperative hypoxemia. Therefore, we conducted this real-world study to test the efficacy and optimal tilt angle of SRP in reducing hypoxemia during anesthesia recovery in a large sample of patients undergoing thoracoscopic surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-85 years old; Undergo thoracoscopic segment/lobectomy; American Society of Anesthesiologists (ASA) grade 1~3

排除标准

  • Patients with mental or cognitive dysfunction who cannot communicate normally; Patients with tracheal catheters retained in ICU; Patients with cervical spondylosis, ankylosing spondylitis and other patients who cannot lift their upper body; Patients who have participated in other clinical trials; Patients who refuse to sign informed consent; Patients who have had chest surgery in the past.

结局指标

主要结局

Incidence of post-PACU hypoxemia

时间窗: Perioperative

defined as SpO2 \<90% for less than 60 seconds

次要结局

  • The incidence of severe hypoxemia(Perioperative)
  • the time of the first episode of hypoxemia(Perioperative)
  • Airway first aid(Perioperative)
  • Breathing comfort(Perioperative)
  • Wound pain VAS score(measured and recorded at rest and cough, 5 and 30 minutes after extubation, before leaving PACU and 24,48 and 72 hours postoperative)
  • blood gas analysis(Perioperative)
  • The duration of PACU stay(Perioperative)
  • Heart rate(Upon admission, before induction, after intubation, immediately after the end of surgery, immediately before extubation, immediately after admission to PACU and adjustment of position, 10 minutes after admission to PACU, and upon departure from PACU)
  • Mean arterial pressure(Upon admission, before induction, after intubation, immediately after the end of surgery, immediately before extubation, immediately after admission to PACU and adjustment of position, 10 minutes after admission to PACU, and upon departure from PACU)

研究者

发起方
Shanghai Pulmonary Hospital, Shanghai, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hao Yang

post-doctoral

Shanghai Pulmonary Hospital, Shanghai, China

研究点 (1)

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