Effects of High-Flow Nasal Oxygen Versus Conventional Face Mask Oxygen on Cerebral Oxygenation During Out-of-Operating-Room Procedural Sedation: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Regional Cerebral Oxygen Saturation (ΔrSO₂)
研究概览
简要总结
This prospective randomized controlled trial aims to compare the effects of high-flow nasal oxygen (HFNO) and conventional face mask oxygen therapy on cerebral oxygenation during procedural sedation performed outside the operating room. Adult patients undergoing elective diagnostic or interventional procedures under procedural sedation will be randomly assigned to receive either HFNO or conventional face mask oxygen. Regional cerebral oxygen saturation will be continuously monitored using near-infrared spectroscopy (NIRS), while sedation depth will be assessed using the Patient State Index (PSI, SedLine) and the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. Secondary outcomes include peripheral oxygenation, ventilation parameters, arterial blood gas values, airway interventions, hemodynamic variables, and patient and practitioner satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, 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
- 否
入选标准
- •Age 18 years or older
- •American Society of Anesthesiologists physical status I-IV
- •Scheduled for an elective diagnostic or interventional procedure performed under procedural sedation in a non-operating-room setting
- •Ability to provide written informed consent
- •Willingness to participate in the study
排除标准
- •Age younger than 18 years
- •Refusal or inability to provide written informed consent
- •Known neurological disorders
- •History of ischemic or hemorrhagic stroke
- •History of traumatic brain injury or previous cranial surgery
- •Peripheral arterial disease or systemic vasculitis
- •Advanced heart failure
- •Uncontrolled hypertension
- •Uncontrolled diabetes mellitus
- •Advanced chronic obstructive pulmonary disease (COPD)
- •Severe anemia (hemoglobin <8 g/dL)
- •Skin lesions or other conditions preventing proper placement of NIRS sensors
- •Nasal deformity or nasal obstruction preventing the use of high-flow nasal oxygen therapy
- •Any condition that, in the opinion of the investigators, could interfere with study participation or the interpretation of study results
研究组 & 干预措施
High-Flow Nasal Oxygen (HFNO)
Participants receive heated humidified high-flow nasal oxygen during procedural sedation.
干预措施: High-Flow Nasal Oxygen (HFNO) (Device)
Conventional Face Mask Oxygen
Participants receive conventional face mask oxygen therapy during procedural sedation.
干预措施: Conventional Face Mask Oxygen (Device)
结局指标
主要结局
Change in Regional Cerebral Oxygen Saturation (ΔrSO₂)
时间窗: From initiation of procedural sedation until completion of the procedure (up to approximately 120 minutes).
The change in regional cerebral oxygen saturation (rSO₂) measured by near-infrared spectroscopy (NIRS), calculated as the difference between the mean intra-procedural rSO₂ and the baseline value.
次要结局
- Peripheral Oxygen Saturation (SpO₂)(From baseline to completion of procedural sedation (up to approximately 120 minutes).)
- End-Tidal Carbon Dioxide (EtCO₂)(Baseline and at completion of the procedure.)
- Arterial Oxygen Tension (PaO₂)(Before sedation and immediately after completion of the procedure.)
- Arterial Carbon Dioxide Tension (PaCO₂)(Before sedation and immediately after completion of the procedure.)
- Incidence of Hypoxemia(During procedural sedation (up to approximately 120 minutes).)
- Number of Participants with a ≥20% Decrease in Regional Cerebral Oxygen Saturation (rSO₂) from Baseline(During procedural sedation (up to approximately 120 minutes).)
- Number of Participants Requiring Airway Intervention During Procedural Sedation(During procedural sedation.)
- Patient State Index (PSI) During Procedural Sedation(Throughout procedural sedation until completion of the procedure.)
- Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score During Procedural Sedation(Throughout procedural sedation until completion of the procedure.)
- Heart Rate During Procedural Sedation(From baseline until completion of the procedure.)
- Mean Arterial Pressure During Procedural Sedation(Throughout procedural sedation until completion of the procedure.)
- Sedative Drug Consumption(During procedural sedation.)
- Patient Satisfaction Score Using a 5-Point Likert Scale(Immediately after recovery from procedural sedation.)
- Practitioner Satisfaction Score Using a 5-Point Likert Scale(Immediately after completion of the procedure.)
研究者
AHMET AKSU
Assistant Professor
Firat University