HypoxemiaNCT01370993
The Prediction Model of Hypoxemia for Safe Bronchoscopy
An observational study of Hypoxemia and Obstructive Sleep Apnea, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to develop the hypoxemia prediction model during fiberoptic bronchoscopy under MAC(monitored anesthesia care) anesthesia. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hypoxemia, Obstructive Sleep Apnea
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Dec 2012
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patienst who are planned to get fiberoptic bronchoscopy under MAC anesthesia in Seoul National University Bundang Hospital
Who may be able to join
- Age> 15 yrs
- patients who are planned to get fiberoptic bronchoscopy under MAC anesthesia in Seoul National University Bundang Hospital
Who cannot join
- Patients who will get Endobronchial ultrasound guided transbronchial needle aspiration
- patients whose baseline oxygen saturation is below 90%
- Intubated patients
- Patients do not agree with the study enrollment
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Sei Won Lee
Seongnam-si, Gyeonggi-do, 463-707
Sei Won Lee, M.D., 82-31-787-7053, seiwon@snubh.org
About this study
Official title: The Prediction Model of Hypoxemia for Safe Bronchoscopy Under MAC Anesthesia
The purpose of this study is to develop the hypoxemia prediction model during fiberoptic bronchoscopy under MAC(monitored anesthesia care) anesthesia.
Read the detailed description
Currently, diverse sedatives and analgesic methods are used during fiberoptic bronchoscopy for reducing patients' discomfort and facilities of procedures as British Thoracic Society recommendation. MAC anesthesia, one of the widely used sedative method during bronchoscopy, have many advantages, occurrence of respiratory depression, hypoxemia are not uncommon during the procedures. The investigators try to find out risk factors and develop the prediction model for hypoxemia during bronchoscopy under MAC anesthesia.
- Conditions
- Hypoxemia, Obstructive Sleep Apnea
- Keywords
- Hypoxemia, Model, Bronchoscopes, Monitored anesthesia care
- Medical subject headings
- Hypoxia, Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest oxygen saturation during bronchoscopy, development of hypoxemia(SpO2<90%) during bronchoscopy
Measured: during the fiberoptic bronchoscopy, estimated procedure time is about 15min
Secondary outcomes (4)
Need for oxygen flow increment
Measured: during the fiberoptic bronchoscopy, estimated procedure time is about 15min
the proportion of subjects who is require of mandible lift
Measured: during the fiberoptic bronchoscopy, estimated procedure time is about 15min
time delay for procedure due to hypoxemia
Measured: during the fiberoptic bronchoscopy, estimated procedure time is about 15min
the proportion of subjects with snoring
snoring
Measured: during the fiberoptic bronchoscopy, estimated procedure time is about 15min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sei Won Lee, M.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370993
- Sponsor's protocol ID
- SNUBH-FOB under MAC
- Status last verified
- May 2011
- First submitted
- 31 May 2011
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prediction Model of Hypoxemia for Safe Bronchoscopy Under MAC Anesthesia
- ClinicalTrials.gov ID
- NCT01370993
- Acronym / sponsor ID
- SNUBH-FOB under MAC
- Conditions
- Hypoxemia, Obstructive Sleep Apnea
- Keywords
- Hypoxemia, Model, Bronchoscopes, Monitored anesthesia care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 10 Jun 2011 (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 purpose of this study is to develop the hypoxemia prediction model during fiberoptic bronchoscopy under MAC(monitored anesthesia care) anesthesia.
Detailed description
Currently, diverse sedatives and analgesic methods are used during fiberoptic bronchoscopy for reducing patients' discomfort and facilities of procedures as British Thoracic Society recommendation. MAC anesthesia, one of the widely used sedative method during bronchoscopy, have many advantages, occurrence of respiratory depression, hypoxemia are not uncommon during the procedures. The investigators try to find out risk factors and develop the prediction model for hypoxemia during bronchoscopy under MAC anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patienst who are planned to get fiberoptic bronchoscopy under MAC anesthesia in Seoul National University Bundang Hospital
Key inclusion criteria (2 listed)
- Age> 15 yrs
- patients who are planned to get fiberoptic bronchoscopy under MAC anesthesia in Seoul National University Bundang Hospital
Key exclusion criteria (4 listed)
- Patients who will get Endobronchial ultrasound guided transbronchial needle aspiration
- patients whose baseline oxygen saturation is below 90%
- Intubated patients
- Patients do not agree with the study enrollment
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
Lowest oxygen saturation during bronchoscopy, development of hypoxemia(SpO2<90%) during bronchoscopy
Time frame: during the fiberoptic bronchoscopy, estimated procedure time is about 15min
4 secondary outcomes
Need for oxygen flow increment
Time frame: during the fiberoptic bronchoscopy, estimated procedure time is about 15min
the proportion of subjects who is require of mandible lift
Time frame: during the fiberoptic bronchoscopy, estimated procedure time is about 15min
time delay for procedure due to hypoxemia
Time frame: during the fiberoptic bronchoscopy, estimated procedure time is about 15min
the proportion of subjects with snoring
Time frame: during the fiberoptic bronchoscopy, estimated procedure time is about 15min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
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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.
Sei Won Lee, M.D. principal investigator
Seoul National University Bundang Hospital
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 Hypoxemia and Obstructive Sleep Apnea, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 2 inclusion and 4 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 10 Jun 2011. 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 South Korea. 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 Sei Won Lee, M.D. (82-31-787-7053, seiwon@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lowest oxygen saturation during bronchoscopy, development of hypoxemia(SpO2<90%) during bronchoscopy (time frame: during the fiberoptic bronchoscopy, estimated procedure time is about 15min). 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 10 Jun 2011.