High-flow nasal oxygen versus face mask for oxygen support during sedated, non-intubated thoracoscopic pericardial window

Optimizing Oxygen Delivery During Sedoanalgesia for Video-Assisted Thoracoscopic Pericardial Window: High-Flow Nasal Oxygen vs. Face Mask Oxygenation, A Prospective Comparative Study

This trial will test whether high-flow nasal oxygen or a conventional face mask better prevents low oxygen levels in adults having a sedated, non-intubated VATS pericardial window.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Koşuyolu Kartal Heart Training and Research Hospital (other)
• Locations: 1 site (Istanbul, KARTAL)
• Trial ID: NCT07432607 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, parallel-group trial comparing high-flow nasal oxygen therapy (HFNOT) to a conventional oxygen mask (COM) during sedoanalgesia-guided, non-intubated video-assisted thoracoscopic (NI-VATS) pericardial window procedures. Adults scheduled for elective pericardial window under sedoanalgesia are randomized to receive warmed, humidified HFNOT (flows up to 70 L/min, FiO2 0.21–1.0) or standard face-mask oxygen intraoperatively. The primary outcome is the incidence of intraoperative hypoxia (SpO2 < 92%), with monitoring of hemodynamics and conversion to general anesthesia as key secondary considerations. The trial targets patients aged 18–75 with ASA I–III and excludes those with significant respiratory disease, BMI >30, hemodynamic instability, or other contraindications to sedoanalgesia.

Who should consider this trial

Good fit: Adults 18–75 years old with ASA I–III and BMI ≤30 who are scheduled for elective non-intubated VATS pericardial window under sedoanalgesia and can give informed consent are ideal candidates.

Not a fit: Patients with ASA ≥IV, BMI >30, active symptomatic respiratory disease, preoperative hemodynamic instability, or those requiring conversion to general anesthesia are unlikely to benefit from the interventions tested here.

Why it matters

Potential benefit: If successful, this approach could reduce intraoperative desaturation and related complications, improving safety and recovery for patients undergoing non-intubated thoracoscopic pericardial drainage.

How similar studies have performed: Prior perioperative and respiratory studies have shown HFNOT can improve oxygenation and reduce desaturation in some non-intubated thoracic and procedural settings, but data specific to NI-VATS pericardial window procedures remain limited.

Eligibility criteria

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

Where this trial is running

Istanbul, KARTAL

• Kosuyolu Heart Training and Research Hospital — Istanbul, KARTAL, Turkey (Türkiye) (RECRUITING)

Study contacts

• Principal investigator: Esin ERDEM, MD — Kosuyolu Kartal Heart Training and Research Hospital
• Study coordinator: Ebru GIRGIN DINC, MD

Conditions: Hypoxemia During Surgery, hypoxemia, High Flow Oxygen Therapy, non-ıntubated VATS