The Systemic and Brain Oxygen Stauration Change During Bronchoscopy

NCT04002609 | Completed

• 2 other identifiers: DE KK RKEB/IKEB 4989-201829215/2017
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

NIRS

Keywords

bronchoscopy, NIRS

Outcome Measures

Primary Outcomes (1)

• systemic oxygen saturation

  measure systemic oxygen saturations with Infinity Delta XL

  during bronchoscopy

Secondary Outcomes (1)

• cerebral oxygen saturation

  during bronchoscopy

Study Arms (3)

Group A, Active comparator

Patients in this group did not receive any rountine oxygen supplementation during the procedure. Rescue supplemental oxygen through nasal cannual was provided if clinically significant desaturation could be observed during bronchoscopy. This significant desaturation was defined as systemic oxygen saturation ≤90% on pulsoxymetry or a relative change of ≥ 4% lasting for 1 minute. N=31 patients

Group B, Active comparator

Supplemental oxygen was provided for the patients through nasal cannula by a flow rate of 2 l/minutes throughout the procedure. N= 31 patients

Other: oxygen

Group C, Active comparator

Supplemental oxygen administration through nasal cannula by a flow rate of 4 l/minutes throughout the procedure. N= 30 patients

Other: oxygen

Interventions

oxygen OTHER

oxygen supplementation during brronchoscopy

Group B, Active comparator; Group C, Active comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients admitted to Bronchology Laboratory of Department of Pulmonology, University of Debrecen for flexible bronchoscopy were asked to participate in the study. After explaining the procedure in detail, all patients gave written informed consent.

You may not qualify if:

• age under 18 years

Sponsors & Collaborators

• University of Debrecen: lead

Study Sites (1)

University of Debrecen, Department of Anesthesiology and Intensive Care

Debrecen, Hajdú-Bihar, 4031, Hungary

Location

Related Publications (1)

• Vasko A, Kovacs S, Fulesdi B, Molnar C. Assessment of Systemic and Cerebral Oxygen Saturation during Diagnostic Bronchoscopy: A Prospective, Randomized Study. Emerg Med Int. 2020 Dec 9;2020:8540350. doi: 10.1155/2020/8540350. eCollection 2020.

  PMID: 33505726 DERIVED

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Béla Fülesdi, MD, DSci

  Department of Anesthesiology and Intensive Care, University of Debrecen, Health and Medical Science Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Division of General, Vascular and Thoracic Anesthesia

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 28, 2019
• Study Start: June 30, 2017
• Primary Completion: January 31, 2018
• Study Completion: November 30, 2018
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)