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NCT07432607: 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

Recruiting now NA Last updated 3 May 2026
What this trial tests

NA trial testing High-Flow Nasal Oxygen Therapy (HFNOT) in Hypoxemia During Surgery in 60 participants. Currently enrolling.

Timeline
1 June 2025
Primary endpoint
30 December 2026
1 February 2027

Quick facts

Lead sponsorEbru Girgin Dinc
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposesupportive care
Enrollment60
Start date1 June 2025
Primary completion30 December 2026
Estimated completion1 February 2027
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Ebru Girgin Dinc

Who can join

Adults 18 to 75, any sex, with Hypoxemia During Surgery. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Ebru Girgin Dinc trials

Trials by the same sponsor.

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