HypoxaemiaNCT01786642
Assessment of the Efficacy of Tracheal Oxygen Administration During Bronchoscopy - a Phase II Trial
An observational study of Hypoxaemia, run by KU Leuven at 1 site in Belgium.
Trial summary
The aim of the present study is to measure the time to correction of O2 saturation when in case of desaturation below 90%, O2 administration is switched from the nasal to the tracheal route at a similar flow rate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypoxaemia
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2013to Apr 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients referred for flexible bronchoscopy
Who may be able to join
- patients referred for flexible bronchoscopy
Who cannot join
- broncho-alveolar lavage
- endobronchial plugging
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University hospitals leuven
Leuven, 3000
Jonas Yserbyt, MD, +3216346801, jonas.yserbyt@uzleuven.be
Jonas Yserbyt, MD
About this study
Official title: Assessment of the Efficacy of Tracheal Oxygen Administration During Bronchoscopy - a Phase II Trial.
The aim of the present study is to measure the time to correction of O2 saturation when in case of desaturation below 90%, O2 administration is switched from the nasal to the tracheal route at a similar flow rate.
Read the detailed description
The development of a flexible bronchoscope with a channel dedicated to O2 administration might allow optimization of the oxygen supplementation during bronchoscopy, which reduces the risk of per- and peri-procedural hypoxemia. The investigators will conduct a pilot study corroborating the hypothesis that tracheal supplementation of oxygen during flexible bronchoscopy is advantageous in comparison to nasal cannula supplementation.
The concept of our trial consists of a mono-centric observational study performed in the endoscopy suite of the Respiratory Division, University Hospitals Leuven. All patients will be given informed consent before inclusion.
The aim of the present study is to measure the time to correction of O2 saturation when in case of desaturation below 90%, O2 administration is switched from the nasal to the tracheal route at a similar flow rate.
- Conditions
- Hypoxaemia
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| conscious | bronchoscopy without sedative drugs | |
| conscious sedation | bronchoscopy under midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to correction of SpO2
Measured: procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2013 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxaemiaStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Decramer, KU Leuven
- Investigators
- Christophe Dooms, Md PhD, Study director, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786642
- Sponsor's protocol ID
- AETOB
- Status last verified
- Feb 2013
- First submitted
- 1 Feb 2013
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Tracheal Oxygen Administration During Bronchoscopy - a Phase II Trial.
- ClinicalTrials.gov ID
- NCT01786642
- Acronym / sponsor ID
- AETOB
- Conditions
- Hypoxaemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 8 Feb 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.
The aim of the present study is to measure the time to correction of O2 saturation when in case of desaturation below 90%, O2 administration is switched from the nasal to the tracheal route at a similar flow rate.
Detailed description
The development of a flexible bronchoscope with a channel dedicated to O2 administration might allow optimization of the oxygen supplementation during bronchoscopy, which reduces the risk of per- and peri-procedural hypoxemia. The investigators will conduct a pilot study corroborating the hypothesis that tracheal supplementation of oxygen during flexible bronchoscopy is advantageous in comparison to nasal cannula supplementation.
The concept of our trial consists of a mono-centric observational study performed in the endoscopy suite of the Respiratory Division, University Hospitals Leuven. All patients will be given informed consent before inclusion.
The aim of the present study is to measure the time to correction of O2 saturation when in case of desaturation below 90%, O2 administration is switched from the nasal to the tracheal route at a similar flow rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conscious | – | –bronchoscopy without sedative drugs |
| conscious sedation | – | –bronchoscopy under midazolam |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients referred for flexible bronchoscopy
Key inclusion criteria (1 listed)
- patients referred for flexible bronchoscopy
Key exclusion criteria (2 listed)
- broncho-alveolar lavage
- endobronchial plugging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to correction of SpO2
Time frame: procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 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.
Christophe Dooms, Md PhD study director
Universitaire Ziekenhuizen KU Leuven
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 Hypoxaemia, run by KU Leuven 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 2 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: status not confirmed, as of the sponsor's last update on 8 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonas Yserbyt, MD (+3216346801, jonas.yserbyt@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to correction of SpO2 (time frame: procedure). 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 8 Feb 2013.