Optimizing Oxygen Delivery During Sedoanalgesia for Video-Assisted Thoracoscopic Pericardial Window: High-Flow Nasal Oxygen vs. Face Mask Oxygenation, A Prospective Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Oxygen Saturation Trends
研究概览
简要总结
This is a prospective, randomized, parallel-group clinical trial designed to evaluate the effects of high-flow nasal oxygen therapy (HFNOT) versus conventional oxygen mask (COM) on perioperative hypoxia in patients undergoing video-assisted thoracoscopic (VATS) pericardial window procedures under sedoanalgesia. The pericardial window procedure, indicated for diagnostic and therapeutic drainage of pericardial effusion, is traditionally performed under general anesthesia. However, the use of non-intubated VATS with sedoanalgesia has gained popularity due to reduced morbidity, shorter recovery, and avoidance of complications associated with general anesthesia, especially in elderly and comorbid patients.
During non-intubated VATS, the occurrence of hypoxia and hemodynamic instability may be exacerbated by procedural pneumothorax and underlying cardiac pathology. High-flow nasal oxygen therapy may provide physiological benefits in this setting by reducing airway resistance, improving alveolar ventilation, and minimizing dead space.
The primary outcome of the study is to compare the incidence of perioperative hypoxia between HFNOT and COM groups. Secondary outcomes include patient comfort, intraoperative oxygenation profiles, hemodynamic stability, and recovery parameters. The trial will be conducted at a single academic center with eligible patients randomized into two treatment arms.
详细描述
Pericardial effusion may require therapeutic or diagnostic drainage by pericardiocentesis or creation of a surgical "pericardial window." Video-assisted thoracoscopic surgery (VATS) is the preferred minimally invasive approach, but standard practice employs general anesthesia with tracheal intubation. Since the late 1980s, non-intubated VATS (NI-VATS) performed under sedoanalgesia with regional blocks has gained acceptance, offering lower morbidity, shorter recovery, and avoidance of postoperative pulmonary complications-advantages that are especially valuable in elderly or comorbid patients who are at risk of hypotension or cardiac arrest during induction.
During NI-VATS, iatrogenic pneumothorax and underlying cardiac pathology can precipitate perioperative hypoxia. Conventional oxygen delivery (facemask or low-flow nasal cannula at ≤15 L min-¹) may be insufficient. High-flow nasal oxygen therapy (HFNOT) delivers warmed, humidified gas at up to 70 L min-¹ and FiO₂ 0.21-1.00, matching or exceeding peak inspiratory flow, reducing airway resistance, washing out nasopharyngeal dead space, and improving alveolar ventilation. Perioperative data on HFNOT in NI-VATS remain limited.
In this study, the primary objective is to compare the incidence of intraoperative hypoxia (defined as SpO₂ < 92%) in patients receiving high-flow nasal oxygen therapy (HFNOT) versus a conventional oxygen mask (COM) during sedoanalgesia-guided non-intubated video-assisted thoracoscopic (NI-VATS) pericardial window procedures.
Secondary objectives include the comparison of oxygen saturation trends and nadir SpO₂ values; hemodynamic stability (heart rate and mean arterial pressure); arterial blood gas parameters (pO₂, pCO₂, pH, lactate, and base excess); regional cerebral oxygen saturation (NIRS); procedural and recovery times; postoperative pain scores (VAS); the need for intensive care unit admission; length of hospital stay; and the incidence of pulmonary or cardiovascular complications.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years
- •Scheduled for elective video-assisted thoracoscopic pericardial window procedure under sedoanalgesia
- •ASA Physical Status Classification I-III
- •Able and willing to provide written informed consent
排除标准
- •Age <18 or >75 years
- •ASA Physical Status ≥ IV
- •Body Mass Index (BMI) > 30 kg/m²
- •Need for inotropic support at enrollment
- •Preoperative hemodynamic instability
- •Symptomatic respiratory disease (e.g., pneumonia, nasal congestion, asthma attack)
- •Diagnosed neuromuscular disorder
- •Diagnosed tracheal stenosis
- •Local infection at the site of regional block application
- •Coagulopathy or bleeding diathesis
- •Pregnancy
- •Patients refusing sedoanalgesia
- •Patients refusing study participation
- •Conversion to general anesthesia or use of supraglottic airway intraoperatively
研究组 & 干预措施
Conventional oxygen mask (COM)
Up to 15 liters/min via oxygen mask
干预措施: High-Flow Nasal Oxygen Therapy (HFNOT) (Device)
High-flow nasal oxygen therapy (HFNOT)
Warmed, humidified up to 70 L min-¹, FiO₂ 0.21-1.00 via dedicated nasal cannula
干预措施: Conventional Oxygen Mask (COM) (Device)
结局指标
主要结局
Oxygen Saturation Trends
时间窗: Up to postoperative 30 minutes
Oxygen Saturation Ratio (%)
次要结局
- Oxygen Saturation Trends(Up to postoperative 24 hours)
- Change in Heart Rate Value(Up to postoperative 30 minutes)
- Arterial Blood Gas Parameters(Up to postoperative 24 hours)
- Regional Cerebral Oxygen Saturation(Up to postoperative 0 minutes)
- Need for intensive care(Up to postoperative 24 hours)
- Length of Hospital Stay(Up to 7 days)
- Postoperative Pulmonary and Cardiovascular Complications(Up to postoperative 3 day)
- Mean arterial pressure fluctuations(Up to postoperative 0 minutes)
研究者
Ebru Girgin Dinc
MD
Koşuyolu Kartal Heart Training and Research Hospital