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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoxemia During Surgery
• Intervention / Treatment: Device: High-Flow Nasal Oxygen Therapy (HFNOT); Device: Conventional Oxygen Mask (COM)

Detailed Description

Pericardial effusion may require therapeutic or diagnostic drainage by pericardiocentesis or creation of a surgical "pericardial window." Video-assisted thoracoscopic surgery (VATS) is the preferred minimally invasive approach, but standard practice employs general anesthesia with tracheal intubation. Since the late 1980s, non-intubated VATS (NI-VATS) performed under sedoanalgesia with regional blocks has gained acceptance, offering lower morbidity, shorter recovery, and avoidance of postoperative pulmonary complications-advantages that are especially valuable in elderly or comorbid patients who are at risk of hypotension or cardiac arrest during induction.

During NI-VATS, iatrogenic pneumothorax and underlying cardiac pathology can precipitate perioperative hypoxia. Conventional oxygen delivery (facemask or low-flow nasal cannula at ≤15 L min-¹) may be insufficient. High-flow nasal oxygen therapy (HFNOT) delivers warmed, humidified gas at up to 70 L min-¹ and FiO₂ 0.21-1.00, matching or exceeding peak inspiratory flow, reducing airway resistance, washing out nasopharyngeal dead space, and improving alveolar ventilation. Perioperative data on HFNOT in NI-VATS remain limited.

In this study, the primary objective is to compare the incidence of intraoperative hypoxia (defined as SpO₂ < 92%) in patients receiving high-flow nasal oxygen therapy (HFNOT) versus a conventional oxygen mask (COM) during sedoanalgesia-guided non-intubated video-assisted thoracoscopic (NI-VATS) pericardial window procedures.

Secondary objectives include the comparison of oxygen saturation trends and nadir SpO₂ values; hemodynamic stability (heart rate and mean arterial pressure); arterial blood gas parameters (pO₂, pCO₂, pH, lactate, and base excess); regional cerebral oxygen saturation (NIRS); procedural and recovery times; postoperative pain scores (VAS); the need for intensive care unit admission; length of hospital stay; and the incidence of pulmonary or cardiovascular complications.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ebru GIRGIN DINC, MD; Phone Number: 905446948852; Email: grgnebru@gmail.com
• Study Contact Backup: Name: Esin ERDEM, MD; Phone Number: 905333581722; Email: esin_ner@yahoo.com

Study Locations

• Turkey (Türkiye)
  • KARTAL
    • Istanbul, KARTAL, Turkey (Türkiye), 34860
      • Recruiting
      • Kosuyolu Heart Training and Research Hospital
      • Contact: Ebru GIRGIN DINC; Phone Number: 905446948852; Email: grgnebru@gmail.com
      • Principal Investigator: Esin ERDEM, MD, Anaesthesiologist
      • Sub-Investigator: Ebru GIRGIN DINC, MD, Anaesthesiologist
      • Sub-Investigator: Murat Ersin CARDAK, MD, Associate Professor
      • Sub-Investigator: Atakan ERKILINC, MD, Associate Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional oxygen mask (COM); Up to 15 liters/min via oxygen mask	Device: High-Flow Nasal Oxygen Therapy (HFNOT); 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.
Active Comparator: High-flow nasal oxygen therapy (HFNOT); Warmed, humidified up to 70 L min-¹, FiO₂ 0.21-1.00 via dedicated nasal cannula	Device: Conventional Oxygen Mask (COM); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Saturation Trends	Oxygen Saturation Ratio (%)	Up to postoperative 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Saturation Trends	Oxygen saturation ratio (%)	Up to postoperative 24 hours
Change in Heart Rate Value	İntraoperative Rate of Change in heart rate (%)	Up to postoperative 30 minutes
Arterial Blood Gas Parameters	Changes in pH during perioperative periods.	Up to postoperative 24 hours
Regional Cerebral Oxygen Saturation	Intraoperative NIRS values variability (% change)	Up to postoperative 0 minutes
Need for intensive care	Number of patients requiring intensive care within a total of 24 hours	Up to postoperative 24 hours
Length of Hospital Stay	Number of days hospitalized after the procedure.	Up to 7 days
Postoperative Pulmonary and Cardiovascular Complications	Number of complications score (atelectasis, pneumonia, arrhythmia, or hypotension)	Up to postoperative 3 day
Mean arterial pressure fluctuations	Intraoperative rate of change in mean arterial pressure (%)	Up to postoperative 0 minutes

Collaborators and Investigators

• Sponsor: Ebru Girgin Dinc
• Investigators: Study Chair: Atakan ERKILINC, MD, Ass. Prof., Kosuyolu Kartal Heart Training and Research Hospital; Principal Investigator: Esin ERDEM, MD, Kosuyolu Kartal Heart Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: July 3, 2025
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: hypoxemia; High Flow Oxygen Therapy; non-ıntubated VATS
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia
• Other Study ID Numbers: HFNO/25/16/915

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol and statistical analysis plan may be shared upon reasonable request.
• IPD Sharing Time Frame: Data will be available after the publication of the study results in a peer-reviewed journal.
• IPD Sharing Access Criteria: Data will be available upon publication of the study results.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No