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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
NA trial testing High-Flow Nasal Oxygen Therapy (HFNOT) in Hypoxemia During Surgery in 60 participants. Currently enrolling.
30 December 2026
Quick facts
| Lead sponsor | Ebru Girgin Dinc |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 60 |
| Start date | 1 June 2025 |
| Primary completion | 30 December 2026 |
| Estimated completion | 1 February 2027 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- High-Flow Nasal Oxygen Therapy (HFNOT)
- Conventional Oxygen Mask (COM)
Conditions studied
- Hypoxemia During Surgery — all drugs for Hypoxemia During Surgery →
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.
-
Oxygen Saturation Trends
Time frame: Up to postoperative 30 minutes
Oxygen Saturation Ratio (%)
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.
Verify or expand the search:
- PubMed search for NCT07432607
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Ebru Girgin Dinc trials
Trials by the same sponsor.
- NCT07293273 — Procedural Sedation in Renal Sympathetic Denervation · completed
- NCT07132619 — Kidney Injury After PTE: Association With Hypothermic Circulatory Arrest Duration · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07432607 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ebru Girgin Dinc
- Last refreshed: 3 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07432607.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing