Last reviewed · How we verify

NCT04002609: BFNIRS

The Systemic and Brain Oxygen Stauration Change During Bronchoscopy

Completed Last updated 8 July 2019
What this trial tests

trial testing oxygen in NIRS in 92 participants. Completed in 30 November 2018.

Timeline
30 June 2017
Primary endpoint
31 January 2018
30 November 2018

Quick facts

Lead sponsorUniversity of Debrecen
StatusCompleted
Study typeOBSERVATIONAL
Enrollment92
Start date30 June 2017
Primary completion31 January 2018
Estimated completion30 November 2018
Sites1 location across Hungary

Drugs / interventions tested

Conditions studied

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):

  1. 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:

Other trials of oxygen

Trials testing the same drug.

Other recruiting trials for NIRS

Currently open trials in the same condition.

Other University of Debrecen trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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