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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • High-Flow Nasal Oxygen Therapy (HFNOT)

    Device

    Heated 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)

    Device

    Oxygen 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

60 Participants
are divided into 2 treatment groups
Group A: Conventional oxygen mask (COM)Active comparator 1 intervention
Group B: High-flow nasal oxygen therapy (HFNOT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Oxygen Saturation Trends

Oxygen Saturation Ratio (%)

Time frame
Up to postoperative 30 minutes

Secondary outcomes

1

Oxygen Saturation Trends

Oxygen saturation ratio (%)

Time frame
Up to postoperative 24 hours
2

Change in Heart Rate Value

İntraoperative Rate of Change in heart rate (%)

Time frame
Up to postoperative 30 minutes
3

Arterial Blood Gas Parameters

Changes in pH during perioperative periods.

Time frame
Up to postoperative 24 hours
4

Regional Cerebral Oxygen Saturation

Intraoperative NIRS values variability (% change)

Time frame
Up to postoperative 0 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ebru Girgin Dinc

Lead sponsor

Koşuyolu Kartal Heart Training and Research Hospital

Sponsor institution