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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEbru Girgin Dinc

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

Qualifiers

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

Treatments tested in this trial

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

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ebru Girgin Dinc

Lead sponsor

Koşuyolu Kartal Heart Training and Research Hospital

Sponsor institution