About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age <18 or >75 years
ASA Physical Status ≥ IV
Body Mass Index (BMI) > 30 kg/m²
Need for inotropic support at enrollment
Trial design
Parallel
Treatments tested in this trial
High-Flow Nasal Oxygen Therapy (HFNOT)
DeviceHeated and humidified oxygen will be administered through a high-flow nasal cannula. Flow rates will up to 70 L/min with an FiO₂ of 0.21 to 1.00, delivered at a temperature of 37°C. The intervention will be applied from entry into the operating room until the end of the surgical procedure during sedoanalgesia-guided non-intubated VATS pericardial window surgery.
Conventional Oxygen Mask (COM)
DeviceOxygen will be delivered via a standard face mask up to 15 L/min with an FiO₂ of 0.21-1.00. The oxygen support will be provided from entry into the operating room until the end of the procedure during sedoanalgesia-guided non-intubated VATS pericardial window surgery.
Treatment groups
Trial outcomes
Primary outcomes
Oxygen Saturation Trends
Oxygen Saturation Ratio (%)
Secondary outcomes
Oxygen Saturation Trends
Oxygen saturation ratio (%)
Change in Heart Rate Value
İntraoperative Rate of Change in heart rate (%)
Arterial Blood Gas Parameters
Changes in pH during perioperative periods.
Regional Cerebral Oxygen Saturation
Intraoperative NIRS values variability (% change)
Sponsors and contacts
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Ebru Girgin Dinc
Lead sponsor
Koşuyolu Kartal Heart Training and Research Hospital
Sponsor institution