Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Kosuyolu Heart Training and Research Hospital
RECRUITING
Istanbul
Contact Information
Primary
Ebru GIRGIN DINC, MD
grgnebru@gmail.com
905446948852
Backup
Esin ERDEM, MD
esin_ner@yahoo.com
905333581722
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2026-02
Participants
Target number of participants: 60
Treatments
Active_comparator: Conventional oxygen mask (COM)
Up to 15 liters/min via oxygen mask
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
Related Therapeutic Areas
Sponsors
Leads: Ebru Girgin Dinc

This content was sourced from clinicaltrials.gov