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High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window Surgery

RecruitingNAAges 18 Years - 75 YearsAllEbru Girgin Dinc
NCT07432607 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ther

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • High-Flow Nasal Oxygen Therapy (HFNOT)
  • Conventional Oxygen Mask (COM)
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Where

1 site
Kosuyolu Heart Training and Research Hospital
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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