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临床试验/NCT07594951
NCT07594951尚未招募不适用

Effect of Different Bed Head Angles on Intraoperative Hypoxemia in Patients Undergoing Painless Gastroenteroscopy: A Prospective Randomized Controlled Study

Xiangya Hospital of Central South University0 个研究点目标入组 400 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400
主要终点
Hypoxemia

研究概览

简要总结

Abstract:

Objective: This study aimed to investigate the effect of different bed angles (0° vs. 15°) on the incidence of intraoperative hypoxemia in patients undergoing gastroscopy and colonoscopy. A prospective randomized controlled trial was conducted to evaluate the impact of patient positioning on respiratory safety, providing evidence for individualized anesthesia management.

Background:

With the increasing popularity of painless gastrointestinal endoscopy, hypoxemia has become a major safety concern in anesthesia management, particularly in elderly and obese patients. Studies have shown that the incidence of hypoxemia can exceed 26%, highlighting the importance of optimizing respiratory safety during anesthesia.

Methods:

A total of 400 patients scheduled for painless gastrointestinal endoscopy were recruited and randomly assigned to a control group (0° left lateral position) or an experimental group (15° left lateral position). Baseline data were recorded preoperatively. Intraoperative vital signs were monitored, and the occurrence of hypoxemia and other complications was documented. Data were collected and processed in a blinded manner, followed by statistical analysis using SPSS 26.0.

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)

入排标准

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

入选标准

  • Age ≥ 18 years
  • Planned to undergo painless (sedated) gastrointestinal endoscopy
  • Signed informed consent form
  • American Society of Anesthesiologists (ASA) Physical Status classification I to III

排除标准

  • Emergency examination or inadequate bowel preparation
  • Baseline peripheral oxygen saturation (SpO₂) < 95%
  • Patient or family members refuse to participate in the study

研究组 & 干预措施

Group 15°

Other

Elevating the head of the bed to 15 degrees

干预措施: Elevating the head of the bed to 15 degrees (Other)

Group 0°

No Intervention

结局指标

主要结局

Hypoxemia

时间窗: During the procedure

Hypoxemia (75% \< SpO₂ \< 90% lasting \> 10 seconds and \< 60 seconds)

次要结局

未报告次要终点

研究者

发起方
Xiangya Hospital of Central South University
申办方类型
Other
责任方
Sponsor

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