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

NCT07432607 | Recruiting DMC

• 1 other identifier: HFNO/25/16/915
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxemia During Surgery

Keywords

hypoxemia; High Flow Oxygen Therapy; non-ıntubated VATS

Outcome Measures

Primary Outcomes (1)

• Oxygen Saturation Trends

  Oxygen Saturation Ratio (%)

  Up to postoperative 30 minutes

Secondary Outcomes (8)

• Oxygen Saturation Trends

  Up to postoperative 24 hours

• Change in Heart Rate Value

  Up to postoperative 30 minutes

• Arterial Blood Gas Parameters

  Up to postoperative 24 hours

• Regional Cerebral Oxygen Saturation

  Up to postoperative 0 minutes

• Need for intensive care

  Up to postoperative 24 hours

Study Arms (2)

Conventional oxygen mask (COM)

ACTIVE COMPARATOR

Up to 15 liters/min via oxygen mask

Device: High-Flow Nasal Oxygen Therapy (HFNOT)

High-flow nasal oxygen therapy (HFNOT)

ACTIVE COMPARATOR

Warmed, humidified up to 70 L min-¹, FiO₂ 0.21-1.00 via dedicated nasal cannula

Device: Conventional Oxygen Mask (COM)

Interventions

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)

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.

High-flow nasal oxygen therapy (HFNOT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ebru Girgin Dinc: lead

Study Sites (1)

Kosuyolu Heart Training and Research Hospital

Istanbul, KARTAL, 34860, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Atakan ERKILINC, MD, Ass. Prof.

  Kosuyolu Kartal Heart Training and Research Hospital

  STUDY CHAIR

• Esin ERDEM, MD

  Kosuyolu Kartal Heart Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ebru GIRGIN DINC, MD

CONTACT

905446948852; grgnebru@gmail.com

Esin ERDEM, MD

CONTACT

905333581722; esin_ner@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: February 25, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after the publication of the study results in a peer-reviewed journal.
• Access Criteria: Data will be available upon publication of the study results.

Locations

TU (1)