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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional oxygen mask (COM) | Active Comparator | Up to 15 liters/min via oxygen mask |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Saturation Trends | Oxygen Saturation Ratio (%) | Up to postoperative 30 minutes |
| 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 (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ebru GIRGIN DINC, MD | Contact | 905446948852 | grgnebru@gmail.com | |
| Esin ERDEM, MD | Contact | 905333581722 | esin_ner@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosuyolu Heart Training and Research Hospital | Recruiting | Istanbul | KARTAL | 34860 | Turkey (Türkiye) |
The study protocol and statistical analysis plan may be shared upon reasonable request.
Data will be available after the publication of the study results in a peer-reviewed journal.
Data will be available upon publication of the study results.
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
|
| 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 |