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NCT Number: NCT07432607

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kosuyolu Heart Training and Research Hospital

Istanbul, KARTAL, 34860, Turkey (Türkiye)

Location status: Recruiting

Location contact

Atakan ERKILINC, MD, Associate Professor

SUB_INVESTIGATOR

Ebru GIRGIN DINC

CONTACT

[email protected]

905446948852

Ebru GIRGIN DINC, MD, Anaesthesiologist

SUB_INVESTIGATOR

Esin ERDEM, MD, Anaesthesiologist

PRINCIPAL_INVESTIGATOR

Murat Ersin CARDAK, MD, Associate Professor

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Oxygen Saturation Trends

    Time frame: Up to postoperative 30 minutes

    Oxygen Saturation Ratio (%)

Secondary outcomes

  1. Oxygen Saturation Trends

    Time frame: Up to postoperative 24 hours

    Oxygen saturation ratio (%)

  2. Change in Heart Rate Value

    Time frame: Up to postoperative 30 minutes

    İntraoperative Rate of Change in heart rate (%)

  3. Arterial Blood Gas Parameters

    Time frame: Up to postoperative 24 hours

    Changes in pH during perioperative periods.

  4. Regional Cerebral Oxygen Saturation

    Time frame: Up to postoperative 0 minutes

    Intraoperative NIRS values variability (% change)

  5. Need for intensive care

    Time frame: Up to postoperative 24 hours

    Number of patients requiring intensive care within a total of 24 hours

  6. Length of Hospital Stay

    Time frame: Up to 7 days

    Number of days hospitalized after the procedure.

  7. Postoperative Pulmonary and Cardiovascular Complications

    Time frame: Up to postoperative 3 day

    Number of complications score (atelectasis, pneumonia, arrhythmia, or hypotension)

  8. Mean arterial pressure fluctuations

    Time frame: Up to postoperative 0 minutes

    Intraoperative rate of change in mean arterial pressure (%)

Study contacts

Contact information is provided by the study sponsor or research team.

Ebru GIRGIN DINC, MD

CONTACT

[email protected]

905446948852

Esin ERDEM, MD

CONTACT

[email protected]

905333581722

Sponsors and collaborators

Lead sponsor

Ebru Girgin Dinc

Other

Registry information

Official study title

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

Acronym: HIFI-NIVATS

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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