NIRSBFNIRSNCT04002609
The Systemic and Brain Oxygen Stauration Change During Bronchoscopy
An observational study of NIRS, run by University of Debrecen at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NIRS
- What is being tested?
- oxygen
- How many people
- 92 participants
- Where
- 1 siteHungary
- Study dates
- 30 Jun 2017to 30 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- inclusion criteria: adult patients (over 18 years) going elective bronchoscopy
Who cannot join
- age under 18 years
Trial locations and contacts
1 site in 1 country.
Hungary1 site
University of Debrecen, Department of Anesthesiology and Intensive Care
Debrecen, Hajdú-Bihar, 4031
About this study
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).
Read the 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.
- Conditions
- NIRS
- Being tested
- oxygen
- Keywords
- bronchoscopy, NIRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygenOther
oxygen supplementation during brronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
systemic oxygen saturation
measure systemic oxygen saturations with Infinity Delta XL
Measured: during bronchoscopy
Secondary outcomes (1)
cerebral oxygen saturation
measure cerebral oxygen saturation with INVOS Model 5100C Cerebral I Somatic Oximeter
Measured: during bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start30 Jun 2017
- Primary completion31 Jan 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NIRSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Debrecen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamas Vegh, MD, University of Debrecen
- Investigators
- Béla Fülesdi, MD, DSci, Principal investigator, Department of Anesthesiology and Intensive Care, University of Debrecen, Health and Medical Science Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002609
- Sponsor's protocol ID
- DE KK RKEB/IKEB 4989-2018
- Other IDs
- 29215/2017, DE KK RKEB/IKEB 4989-2018
- Acronym
- BFNIRS
- Status last verified
- Jul 2019
- First submitted
- 18 Jun 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33505726
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Systemic and Brain Oxygen Stauration Change During Bronchoscopy
- ClinicalTrials.gov ID
- NCT04002609
- Acronym / sponsor ID
- BFNIRS / DE KK RKEB/IKEB 4989-2018
- Conditions
- NIRS
- Keywords
- bronchoscopy, NIRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of DebrecenUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: oxygenSupplemental oxygen was provided for the patients through nasal cannula by a flow rate of 2 l/minutes throughout the procedure. N= 31 patients |
| Group C, Active comparator | – | Other: oxygenSupplemental oxygen administration through nasal cannula by a flow rate of 4 l/minutes throughout the procedure. N= 30 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- inclusion criteria: adult patients (over 18 years) going elective bronchoscopy
Key exclusion criteria (1 listed)
- age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygenoxygen supplementation during brronchoscopy | Other | Group B, Active comparator, Group C, Active comparator |
Primary outcome
systemic oxygen saturation
Time frame: during bronchoscopy
measure systemic oxygen saturations with Infinity Delta XL
1 secondary outcome
cerebral oxygen saturation
Time frame: during bronchoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Derived from this study: PubMed 33505726Vasko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Béla Fülesdi, MD, DSci principal investigator
Department of Anesthesiology and Intensive Care, University of Debrecen, Health and Medical Science Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NIRS, run by University of Debrecen at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systemic oxygen saturation (time frame: during bronchoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04002609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.