Sleep ApneasleeposaNCT01871259
Clinical Predictors of Apnea-hypopnea During Propofol Sedation
An observational study of Sleep Apnea, run by Samsung Medical Center.
Trial summary
To relate two different predictive values of sleep apnea: the STOP score (snoring while sleeping, daytime tiredness, observed breathing stoppages, and high blood pressure) and the estimated respiratory disturbance index (eRDI) with the occurrence of apnea-hypopnea during propofol sedation,thirty four middle-aged male… Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Sleep Apnea
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Nov 2009
- 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 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: We expected a correlation coefficient of ~0.5 in this study, which meant that for a level of significance of 5% and a power of 80%, we required 29 analyzable subjects. Based on a predicted exclusion rate of 15%, 34 patients were included.
Who may be able to join
- Thirty four males who underwent spinal anaesthesia for transurethral resection of the bladder (TURB) or prostate (TURP) were enrolled in this studyInclusion criteria were American Society of Anaesthesiologists (ASA) physical status of 1-2, and ages of more than 40 years.
Who cannot join
- Patients with electrocardiographic or simple chest radiographic abnormalities or who had taken medication that could affect their sleep patterns were excluded.
About this study
Official title: Clinical Predictors of Apnea-hypopnea During Propofol Sedation in Patients Undergoing Spinal Anaesthesia
To relate two different predictive values of sleep apnea: the STOP score (snoring while sleeping, daytime tiredness, observed breathing stoppages, and high blood pressure) and the estimated respiratory disturbance index (eRDI) with the occurrence of apnea-hypopnea during propofol sedation,thirty four middle-aged male patients who underwent urologic surgery under spinal anaesthesia will be enrolled. Before surgery, patients will be asked to complete a STOP-questionnaire. The eRDI will be calculated using the modified Mallampati's grade, tonsil grade, and the body mass index. After performing spinal anaesthesia, propofol will be infused and adjusted to BIS 70-75. An ApneaLinkTM, which measures airflow through a nasal cannula, will be then applied to estimate the level of apnea-hypopnea.
Read the detailed description
The investigators will evaluate correlation between STOP scor and AHI(apnea hypopnea index) or eRDI and AHI. After then the investigators will compare AHI severity between high risk group and low risk group subgrouped according to STOP score or eRDI.
- Conditions
- Sleep Apnea
- Keywords
- Sedation, sleep apnea, propofol
- Medical subject headings
- Sleep Apnea Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea hypopnea index
After surgery, an ApneaLinkTM was connected to a personal computer to record and auto-analyze AHIs. Aopnea was defined as a cessation of airflow for 10s or longer. Hypopnea was defined as a greater than 50% reduction in airflow for 10s or longer. AHI was defined as the number of aopnea and hypopnea incidents per hour.
Measured: 1hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startNov 2008
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Finished
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Jin Lee, Samsung Medical Center
- Investigators
- Jeong Jin Lee, Professor, Principal investigator, : Department of Anaesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871259
- Sponsor's protocol ID
- sleeposa
- Acronym
- sleeposa
- Status last verified
- Jun 2013
- First submitted
- 4 Jun 2013
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Predictors of Apnea-hypopnea During Propofol Sedation in Patients Undergoing Spinal Anaesthesia
- ClinicalTrials.gov ID
- NCT01871259
- Acronym / sponsor ID
- sleeposa / sleeposa
- Conditions
- Sleep Apnea
- Keywords
- Sedation, sleep apnea, propofol
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Finished
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 6 Jun 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.
To relate two different predictive values of sleep apnea: the STOP score (snoring while sleeping, daytime tiredness, observed breathing stoppages, and high blood pressure) and the estimated respiratory disturbance index (eRDI) with the occurrence of apnea-hypopnea during propofol sedation,thirty four middle-aged male patients who underwent urologic surgery under spinal anaesthesia will be enrolled. Before surgery, patients will be asked to complete a STOP-questionnaire. The eRDI will be calculated using the modified Mallampati's grade, tonsil grade, and the body mass index. After performing spinal anaesthesia, propofol will be infused and adjusted to BIS 70-75. An ApneaLinkTM, which measures airflow through a nasal cannula, will be then applied to estimate the level of apnea-hypopnea.
Detailed description
The investigators will evaluate correlation between STOP scor and AHI(apnea hypopnea index) or eRDI and AHI. After then the investigators will compare AHI severity between high risk group and low risk group subgrouped according to STOP score or eRDI.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We expected a correlation coefficient of ~0.5 in this study, which meant that for a level of significance of 5% and a power of 80%, we required 29 analyzable subjects. Based on a predicted exclusion rate of 15%, 34 patients were included.
Key inclusion criteria (1 listed)
- Thirty four males who underwent spinal anaesthesia for transurethral resection of the bladder (TURB) or prostate (TURP) were enrolled in this studyInclusion criteria were American Society of Anaesthesiologists (ASA) physical status of 1-2, and ages of more than 40 years.
Key exclusion criteria (1 listed)
- Patients with electrocardiographic or simple chest radiographic abnormalities or who had taken medication that could affect their sleep patterns were excluded.
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
Apnea hypopnea index
Time frame: 1hour
After surgery, an ApneaLinkTM was connected to a personal computer to record and auto-analyze AHIs. Aopnea was defined as a cessation of airflow for 10s or longer. Hypopnea was defined as a greater than 50% reduction in airflow for 10s or longer. AHI was defined as the number of aopnea and hypopnea incidents per hour.
Results and safety
The study was stopped early (reason given: Finished). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 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.
Jeong Jin Lee, Professor principal investigator
: Department of Anaesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by Samsung Medical Center.
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: stopped early, as of the sponsor's last update on 6 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Finished). Results are not available in the source record.
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?
Apnea hypopnea index (time frame: 1hour). 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 6 Jun 2013.