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NCT04002609: BFNIRS
The Systemic and Brain Oxygen Stauration Change During Bronchoscopy
trial testing oxygen in NIRS in 92 participants. Completed in 30 November 2018.
31 January 2018
Quick facts
| Lead sponsor | University of Debrecen |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 92 |
| Start date | 30 June 2017 |
| Primary completion | 31 January 2018 |
| Estimated completion | 30 November 2018 |
| Sites | 1 location across Hungary |
Drugs / interventions tested
- oxygen — full drug profile →
Conditions studied
- NIRS — all drugs for NIRS →
Sponsor
University of Debrecen
Who can join
18 and older, any sex, with NIRS. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Bronchofiberoscopy is a widespread invasive intervention in clinical practice with a number of diagnostic and therapeutic indications. The Clinic of Pulmonary Medicine in Debrecen carries out nearly 2000 examinations a year. The intervention is guided by the recommendation of the Vocational College for Pulmonary Medicine in 2005, but it does not contain a clear recommendation on the oxygen therapy used during the intervention. The Hungarian recommendation states that pulsoximetry is mandatory in bronchoscopy, but it does not contain information on the indications and the implementation of oxygen suplementation. The British Thoracic Society Guideline 2013 deals with the issue and makes the following statements: * patients should be monitored for oxygen saturation under bronchofiberoscopy * oxygen supplementation during the test is recommended if the patient's desaturation is significant (greater than 4% or less than 90%) and is over 1 minute * during the bronchoscopy, the occurrence of oxygen saturation decreases depending on the level of initial oxygen saturation, respiratory function, co-morbidity, sedation and the course of intervention. The aim of our study is to investigate the frequency with which systemic hypoxia occurs during bronchoscopy, what factors may contribute to its development and how the level of cerebral oxygen saturation changes with systemic desaturation (in the case of NIRS, a 20% reduction from baseline is considered significant).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Assessment of Systemic and Cerebral Oxygen Saturation during Diagnostic Bronchoscopy: A Prospective, Randomized Study.
Vaskó A, Kovács S, Fülesdi B, Molnár C. · · 2020 · PMID 33505726 · DOI 10.1155/2020/8540350
Verify or expand the search:
- PubMed search for NCT04002609
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04002609 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Debrecen
- Last refreshed: 8 July 2019
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/NCT04002609.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing