Actively Recruiting
High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window Surgery
Led by Ebru Girgin Dinc · Updated on 2026-05-05
60
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Age less than 18 or greater than 75 years
- ASA Physical Status IV or higher
- Body Mass Index greater than 30 kg/m2
- Need for inotropic support at enrollment
- Preoperative hemodynamic instability
- Symptomatic respiratory disease such as pneumonia, nasal congestion, or 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kosuyolu Heart Training and Research Hospital
Istanbul, KARTAL, Turkey (Türkiye), 34860
Actively Recruiting
Research Team
E
Ebru GIRGIN DINC, MD
CONTACT
E
Esin ERDEM, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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