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临床试验/NCT07445256
NCT07445256尚未招募不适用

Incidence, Duration, and Clinical Impact of Recovery-Period Hypoxemia Following Sedated Upper Gastrointestinal Endoscopy: A Prospective Observational Study

Istinye University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Recovery-Period Respiratory Events

研究概览

简要总结

Sedation during upper gastrointestinal endoscopy may lead to respiratory events not only during the procedure but also in the early recovery period. Although most hypoxemic episodes are considered transient, their frequency, duration, and clinical consequences during recovery remain insufficiently defined.

This prospective observational study aims to evaluate the incidence, duration, and clinical impact of recovery-period hypoxemia following sedated upper gastrointestinal endoscopy. Hypoxemia is defined as SpO₂ <90% lasting ≥10 seconds. Associated respiratory events and potential risk factors will be analyzed without altering routine clinical practice.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged ≥18 years
  • Scheduled for upper gastrointestinal endoscopy (EGD) under anesthesiologist-administered sedation
  • Able to undergo post-procedure monitoring in the recovery unit
  • Provided written informed consent for participation and data use

排除标准

  • Colonoscopy or combined procedures (EGD + colonoscopy)
  • Emergency procedures or procedures performed under intensive care conditions
  • Requirement for endotracheal intubation, noninvasive ventilation, or advanced airway support during the procedure
  • Known severe upper airway anatomical abnormalities, facial deformity, or tracheostomy
  • Inability or refusal to provide informed consent
  • Incomplete or unavailable recovery-period oxygen saturation monitoring data

结局指标

主要结局

Recovery-Period Respiratory Events

时间窗: From end of procedure (scope-out) until discharge from recovery unit

Occurrence of respiratory events during the recovery period following sedated upper gastrointestinal endoscopy, defined as at least one of the following: SpO₂ \<90% lasting ≥10 seconds Requirement for airway maneuver (jaw-thrust, chin-lift, OPA/NPA, mask ventilation) Escalation or re-initiation of supplemental oxygen

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

İlke Dolgun

Assoc. prof

Istinye University

研究点 (1)

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