BronchoscopyNCT01963377
Toward the Development of a Bronchoscope With a Dedicated O2 Channel ?
A study testing O2 through nasal cannulae and O2-channel in people with Bronchoscopy and O2-supplementation, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
Feasibility of using an extra bronchoscopic channel for supplementation of oxygen will be studied by comparing O2-supplementation by nasal cannulae versus O2-supplementation through aspiration channel of the bronchoscope. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchoscopy, O2-supplementation
- What is being tested?
- O2 through nasal cannulae and O2-channel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2013to Feb 2013
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subject
Who cannot join
- younger than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Feasibility of Dedicated Extra O2-channel in a Bronchoscope.
Feasibility of using an extra bronchoscopic channel for supplementation of oxygen will be studied by comparing O2-supplementation by nasal cannulae versus O2-supplementation through aspiration channel of the bronchoscope.
Read the detailed description
Comparison of O2 administration using bronchoscope versus nasal cannulae in normal volunteers.
This study will compare partial pressure of oxygen measured in capillary blood (PcO2) at various O2 flow from 0 to 2 and 4 l/min administered using nasal cannulae or bronchoscope. During bronchoscopy, oxygen will be administered throughout the aspirating channel of the scope which extremity will be positioned at mid-tracheal level. After local anesthesia of the airways using lignocaine spray 10% and solution 1%, the bronchoscope will be introduced in seated position using a mouthpiece and placed at mid-tracheal level. Arterial O2-pressure sampled at the earlobe will be measured after incremental O2-supplementation from 0 to 2 and then 4 l/min using a nasal cannula or the aspirating channel of the bronchoscope. At each flow rate, capillary O2-pressure will be measured after 2 minutes. Between each condition of O2-supplementation there will be a pause of 5 minutes of room air breathing. The order of O2-supplementation condition will be selected at random. The whole bronchoscopic procedure should then last about 15 minutes. Additional doses of lignocaine 1% will be instilled in the trachea as requested and O2 saturation and heart rhythm will be monitored continuously during the procedure. Since the subjects are probably able to perceive additional flows in the nose and/or trachea and this may affect the pattern of breathing and the results, air at similar flow rate will be added in the nasal cannulae when O2 is administered using the bronchoscope channel and vice versa such that the subject will be blinded to the way O2 is administered.
This study should allow to demonstrate higher values of capillary O2-pressure during bronchoscopic administration of O2 than when using nasal cannulae. As shown by a recent meta-analysis, partial pressure of O2 measured in capillary blood from the arterialized earlobe (PcO2) is lower than the arterial value but this factor is not important in the present study since it will concentrate on differences in PO2 between the two conditions at similar O2 flow rates that are not affected by this limitation.
- Conditions
- Bronchoscopy, O2-supplementation
- Being tested
- O2 through nasal cannulae, O2-channel
- Keywords
- bronchoscopy, O2-supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O2 through nasal cannulaeDevice
supplementation of O2 through nasal cannulae during bronchoscopy
O2-channelDevice
supplementation of O2 through aspiration channel of bronchoscope during bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| 1. Nasal Cannulae / 2. Bronchoscope channel | Experimental | Supplementation of O2 through will take place first through the aspiration channel of the bronchoscope, in second phase of the study O2-supplementation will be done through nasal cannulae. Receives: Device: O2 through nasal cannulae; Device: O2-channel |
| 1. Bronchoscope channel / 2. Nasal Cannulae | Experimental | Supplementation of O2 through will take place first through nasal cannulae, in second phase of the study O2-supplementation will be done through the aspiration channel of the bronchoscope. Receives: Device: O2 through nasal cannulae; Device: O2-channel |
What is being measured
The primary outcome is the main question the study is designed to answer.
PcO2 difference
PcO2 difference after different modes of O2-supplementation (nasal cannulae vs O2 through aspiration channel of bronchoscope) will be measured and compared
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchoscopyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincent Ninane, Centre Hospitalier Universitaire Saint Pierre
- Investigators
- Vincent Ninane, Prof., MD, Principal investigator, CHU St. Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963377
- Sponsor's protocol ID
- B076201215478
- Other IDs
- AK/12-11-90/4190
- Status last verified
- Oct 2013
- First submitted
- 9 Oct 2013
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Feasibility of Dedicated Extra O2-channel in a Bronchoscope.
- ClinicalTrials.gov ID
- NCT01963377
- Acronym / sponsor ID
- B076201215478
- Conditions
- Bronchoscopy, O2-supplementation
- Keywords
- bronchoscopy, O2-supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 Oct 2013 (estimated)
- 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.
Feasibility of using an extra bronchoscopic channel for supplementation of oxygen will be studied by comparing O2-supplementation by nasal cannulae versus O2-supplementation through aspiration channel of the bronchoscope.
Detailed description
Comparison of O2 administration using bronchoscope versus nasal cannulae in normal volunteers.
This study will compare partial pressure of oxygen measured in capillary blood (PcO2) at various O2 flow from 0 to 2 and 4 l/min administered using nasal cannulae or bronchoscope. During bronchoscopy, oxygen will be administered throughout the aspirating channel of the scope which extremity will be positioned at mid-tracheal level. After local anesthesia of the airways using lignocaine spray 10% and solution 1%, the bronchoscope will be introduced in seated position using a mouthpiece and placed at mid-tracheal level. Arterial O2-pressure sampled at the earlobe will be measured after incremental O2-supplementation from 0 to 2 and then 4 l/min using a nasal cannula or the aspirating channel of the bronchoscope. At each flow rate, capillary O2-pressure will be measured after 2 minutes. Between each condition of O2-supplementation there will be a pause of 5 minutes of room air breathing. The order of O2-supplementation condition will be selected at random. The whole bronchoscopic procedure should then last about 15 minutes. Additional doses of lignocaine 1% will be instilled in the trachea as requested and O2 saturation and heart rhythm will be monitored continuously during the procedure. Since the subjects are probably able to perceive additional flows in the nose and/or trachea and this may affect the pattern of breathing and the results, air at similar flow rate will be added in the nasal cannulae when O2 is administered using the bronchoscope channel and vice versa such that the subject will be blinded to the way O2 is administered.
This study should allow to demonstrate higher values of capillary O2-pressure during bronchoscopic administration of O2 than when using nasal cannulae. As shown by a recent meta-analysis, partial pressure of O2 measured in capillary blood from the arterialized earlobe (PcO2) is lower than the arterial value but this factor is not important in the present study since it will concentrate on differences in PO2 between the two conditions at similar O2 flow rates that are not affected by this limitation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Nasal Cannulae / 2. Bronchoscope channel | Experimental | Device: O2 through nasal cannulae, Device: O2-channelSupplementation of O2 through will take place first through the aspiration channel of the bronchoscope, in second phase of the study O2-supplementation will be done through nasal cannulae. |
| 1. Bronchoscope channel / 2. Nasal Cannulae | Experimental | Device: O2 through nasal cannulae, Device: O2-channelSupplementation of O2 through will take place first through nasal cannulae, in second phase of the study O2-supplementation will be done through the aspiration channel of the bronchoscope. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy subject
Key exclusion criteria (1 listed)
- younger than 18 years old
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 |
|---|---|---|
| O2 through nasal cannulaesupplementation of O2 through nasal cannulae during bronchoscopy | Device | 1. Bronchoscope channel / 2. Nasal Cannulae, 1. Nasal Cannulae / 2. Bronchoscope channel |
| O2-channelsupplementation of O2 through aspiration channel of bronchoscope during bronchoscopy | Device | 1. Bronchoscope channel / 2. Nasal Cannulae, 1. Nasal Cannulae / 2. Bronchoscope channel |
Primary outcome
PcO2 difference
Time frame: 1 hour
PcO2 difference after different modes of O2-supplementation (nasal cannulae vs O2 through aspiration channel of bronchoscope) will be measured and compared
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 16 Oct 2013.
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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.
Vincent Ninane, Prof., MD principal investigator
CHU St. Pierre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing O2 through nasal cannulae and O2-channel in people with Bronchoscopy and O2-supplementation, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 16 Oct 2013. 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 Belgium. 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?
PcO2 difference (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2013.