THRIVE Versus Standard Nasal Cannula for Oxygenation, Oxygen Reserve Index, and Hypoxemia During Sedated Gastrointestinal Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Incidence of Hypoxemia During Procedural Sedation
研究概览
简要总结
This prospective observational study aims to evaluate the effectiveness of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) compared to standard nasal cannula (SNC) oxygen supplementation in patients undergoing elective diagnostic gastroscopy under propofol sedation. The primary outcome is the incidence of hypoxemia (SpO₂ <93% for ≥20 seconds) during the procedure. Secondary outcomes include the need for airway intervention, Oxygen Reserve Index (ORi) values, peripheral oxygen saturation (SpO₂) levels, and hemodynamic parameters recorded throughout the procedure. Oxygen delivery method was selected by the attending anesthesia provider independent of the study team.
详细描述
Procedural sedation for gastrointestinal endoscopy is associated with risks of respiratory depression, airway obstruction, and hypoxemia due to the pharmacological effects of sedative agents. Standard nasal cannula (SNC) oxygen supplementation, while widely used, is limited in its ability to guarantee adequate inspired oxygen concentrations, particularly during apneic episodes.
THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) delivers heated and humidified oxygen at flow rates up to 70 L/min via a non-invasive nasal cannula. The high-flow system generates positive nasopharyngeal pressure, reduces anatomical dead space through a washout effect, increases end-expiratory lung volume, and extends safe apnea time by delaying arterial desaturation. These physiological mechanisms may offer significant advantages over standard low-flow oxygen delivery during sedated endoscopy.
In this single-center prospective observational study, adult patients (age ≥18, ASA I-III, BMI <35 kg/m²) undergoing elective diagnostic gastroscopy under propofol sedation were monitored with continuous SpO₂, ETCO₂, BIS, and non-invasive Oxygen Reserve Index (ORi) monitoring. Supplemental oxygen was provided either via THRIVE at 30 L/min or standard nasal cannula at 10 L/min, based on the attending anesthesiologist's preference. Preoxygenation was initiated 2 minutes before induction and continued until procedure completion. Sedation was maintained with propofol 1-1.5 mg/kg targeting BIS 60-80; fentanyl 0.5-1 mcg/kg was administered when required. Hemodynamic and respiratory parameters were recorded at baseline, pre-induction, post-induction, intraoperatively, and at procedure end. Airway interventions were standardized and applied when apnea lasted ≥20 seconds or SpO₂ dropped ≤93% for ≥20 seconds.
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
- 否
入选标准
- •Age ≥18 years
- •ASA physical status I-III
- •Body mass index (BMI) <35 kg/m²
- •Scheduled for elective diagnostic gastroscopy under propofol sedation
- •Baseline SpO₂ >93% on room air prior to the procedure
- •Hemoglobin level ≥10.0 g/dL prior to the procedure
- •Willing and able to provide written informed consent
排除标准
- •Severe chronic pulmonary disease (e.g., COPD, interstitial lung disease)
- •Severe chronic cardiac disease
- •BMI ≥35 kg/m²
- •Pregnancy
- •History of facial or oropharyngeal surgery
- •Baseline SpO₂ ≤93% on room air prior to the procedure
- •Hemoglobinopathy
- •Hemoglobin level <10.0 g/dL prior to the procedure
结局指标
主要结局
Incidence of Hypoxemia During Procedural Sedation
时间窗: From induction of sedation until end of the endoscopic procedure (estimated 10-30 minutes)
Hypoxemia was defined as peripheral oxygen saturation (SpO₂) falling below 93% for a duration of ≥20 seconds, as measured by continuous pulse oximetry. The proportion of patients experiencing at least one hypoxemic episode was compared between the THRIVE and standard nasal cannula groups.
次要结局
- Need for Airway Intervention Due to Hypoxemia or Apnea(From induction of sedation until end of the endoscopic procedure (estimated 10-30 minutes))
- Oxygen Reserve Index (ORi) Throughout the Procedure(Baseline, pre-induction, post-induction, intraoperative, and immediately after procedure completion)
- Peripheral Oxygen Saturation (SpO₂) Throughout the Procedure(Baseline, pre-induction, post-induction, intraoperative, and immediately after procedure completion)
- Intraoperative Hemodynamic Stability(Baseline, pre-induction, post-induction, intraoperative, and immediately after procedure completion)
研究者
Oznur Demiroluk
Associate Professor of Anesthesiology
Fatih Sultan Mehmet Training and Research Hospital