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

July 3, 2019 updated by: Tamas Vegh, MD, University of Debrecen

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
systemic oxygen saturation
Time Frame: during bronchoscopy
measure systemic oxygen saturations with Infinity Delta XL
during bronchoscopy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
cerebral oxygen saturation
Time Frame: during bronchoscopy
measure cerebral oxygen saturation with INVOS Model 5100C Cerebral I Somatic Oximeter
during bronchoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Debrecen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Béla Fülesdi, MD, DSci, Department of Anesthesiology and Intensive Care, University of Debrecen, Health and Medical Science Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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