The Systemic and Brain Oxygen Stauration Change During Bronchoscopy (BFNIRS)

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).

Study Overview

• Status: Completed
• Conditions: NIRS
• Intervention / Treatment: Other: oxygen

Detailed Description

: 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.

The indication of flexible bronchoscopy was based in all cases on the results of medical history, physical examination, chest X-ray and/or chest CT scan, lung function tests and laboratory parameters including hemoglobin concentration, hemostasis variables as well as blood gas analysis when necessary.

Bronchoscopy (PENTAX EB-1975K) was performed after an at least 4-hour fasting period. The procedure was performed either in sitting or supine position after a topical administration of lidocaine 2% solution. Routine monitoring consisted of ECG, non-invasive blood pressure measurement, pulse oxymetry (finger probe). As an additional monitoring tool, near infrared monitoring sensor was placed to the forhead of the dominant hemisphere of patients for monitoring cerebral oxygen saturation. INVOS 5100 C cerebral oximeter (Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA) was used for cerebral near infrared spectroscopy measurements.

• Study Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• Hungary
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4031
      • University of Debrecen, Department of Anesthesiology and Intensive Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

inclusion criteria: adult patients (over 18 years) going elective bronchoscopy

Exclusion Criteria:

age under 18 years

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; oxygen supplementation during brronchoscopy
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; oxygen supplementation during brronchoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systemic oxygen saturation	measure systemic oxygen saturations with Infinity Delta XL	during bronchoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cerebral oxygen saturation	measure cerebral oxygen saturation with INVOS Model 5100C Cerebral I Somatic Oximeter	during bronchoscopy

Collaborators and Investigators

• Sponsor: University of Debrecen
• Investigators: Principal Investigator: Béla Fülesdi, MD, DSci, Department of Anesthesiology and Intensive Care, University of Debrecen, Health and Medical Science Centre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: bronchoscopy, NIRS
• Other Study ID Numbers: DE KK RKEB/IKEB 4989-2018 (Registry Identifier: Local Ethic Comittee University of Debrecen); 29215/2017 (Registry Identifier: Government Offices Public Health Administration Organization)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No