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临床试验/NCT07415161
NCT07415161尚未招募不适用

The Role of Oxygen Reserve Index (ORi) in Identifying Early Desaturation During Endolaryngeal Surgery: A Randomized Clinical Trial

Istanbul University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年1月27日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Time to Reventilation Threshold

研究概览

简要总结

This randomized clinical trial investigates whether Oxygen Reserve Index (ORi) monitoring enables earlier detection of impending hypoxemia compared with conventional pulse oximetry during apneic intermittent ventilation in adult patients undergoing endolaryngeal surgery under general anesthesia. By providing continuous, noninvasive assessment of oxygen reserve in the hyperoxic range, ORi may offer an earlier warning of oxygen depletion before peripheral oxygen saturation declines. The study compares time to reventilation thresholds, arterial blood gas parameters, and perioperative respiratory outcomes between ORi-guided and standard SpO₂-guided monitoring strategies.

详细描述

This prospective, single-center, randomized clinical trial was designed to evaluate the role of the Oxygen Reserve Index (ORi) in the early detection of hypoxemia during apneic intermittent ventilation in adult patients undergoing elective endolaryngeal surgery under general anesthesia. Endolaryngeal procedures require shared airway management and frequently involve apneic periods, during which conventional pulse oximetry may fail to provide timely warning of declining oxygen reserves due to the plateau phase of the oxyhemoglobin dissociation curve. Eligible patients aged 18 years and older with ASA physical status I-III were randomly assigned to either an ORi-monitored group or a control group monitored with standard peripheral oxygen saturation (SpO₂). All patients underwent standardized anesthesia induction, preoxygenation, and apneic intermittent ventilation. In the ORi group, the threshold for resuming ventilation was defined as ORi reaching zero, whereas in the control group ventilation was resumed when SpO₂ decreased to 90%. The primary outcome was the time from the onset of apnea to the predefined reventilation threshold. Secondary outcomes included arterial blood gas parameters (pH, PaO₂, PaCO₂) at the time of reventilation, end-tidal carbon dioxide levels, perioperative lung ultrasound findings, post-anesthesia care unit length of stay, and postoperative respiratory outcomes. This study aims to determine whether ORi monitoring provides earlier and clinically meaningful warning of oxygen reserve depletion compared with conventional pulse oximetry, potentially improving patient safety during shared-airway surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Masking Description

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 or older
  • Scheduled for elective endolaryngeal surgery
  • Planned general anesthesia with apneic intermittent ventilation
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Ability to provide written informed consent

排除标准

  • Age under 18 years
  • Preoperative chronic hypoxemia (baseline SpO₂ < 95%)
  • Patients transferred from the intensive care unit
  • ASA physical status IV or higher
  • Refusal or inability to provide informed consent

研究组 & 干预措施

Oxygen Reserve Index

Experimental

Participants in this arm will undergo continuous Oxygen Reserve Index (ORi) monitoring in addition to standard anesthesia monitoring during general anesthesia with apneic intermittent ventilation for endolaryngeal surgery. ORi values will be used to guide the timing of reventilation, with reventilation initiated when ORi reaches zero, indicating depletion of oxygen reserve. Standard clinical care and anesthesia management will otherwise be identical to the control group.

干预措施: oxygen monitoring techniques (Procedure)

Peripheral oxygen saturation

No Intervention

Participants in this arm will receive standard anesthesia monitoring, including continuous peripheral oxygen saturation (SpO₂) monitoring, during general anesthesia with apneic intermittent ventilation for endolaryngeal surgery. The timing of reventilation will be guided by SpO₂ values, with reventilation initiated when SpO₂ decreases to 90%. All other aspects of anesthesia care and perioperative management will be identical to the experimental arm.

结局指标

主要结局

Time to Reventilation Threshold

时间窗: From the onset of apnea until the predefined reventilation threshold is reached during the intraoperative period (within minutes).

Time from the onset of apnea to the predefined reventilation threshold, defined as Oxygen Reserve Index (ORi) reaching zero in the ORi group and peripheral oxygen saturation (SpO₂) decreasing to 90% in the control group, measured in seconds.

次要结局

  • Arterial Blood Gas Parameters at Reventilation(From the onset of apnea until the predefined reventilation threshold is reached during the intraoperative period (within minutes).)
  • Perioperative Lung Ultrasound Findings(Preoperatively (before anesthesia induction) and postoperatively in the post-anesthesia care unit (within 1 hour after surgery).)
  • Postoperative Oxygenation(postoperatively in the post-anesthesia care unit (within 1 hour after surgery).)
  • End-Tidal Carbon Dioxide (EtCO₂) Level(During the apneic period, measured at the time of reventilation during surgery.)

研究者

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

Demet Altun

Professor

Istanbul University

研究点 (1)

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