Sleep Apnea, ObstructiveNCT01098851
Oxygen Saturation Monitoring During Surgery
An observational study of Sleep Apnea, Obstructive, run by Medtronic - MITG at 1 site in United States.
Trial summary
Patients with Obstructive Sleep Apnea (OSA) have cyclical patterns of lower blood oxygen during sleep because of repeated episodes of upper airway obstruction that cause their breathing to stop. When these patients have surgery, anesthetic drugs may worsen these patterns of lower blood oxygen. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Nov 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care hospital
Who may be able to join
- Age greater than 21 years
- Patients scheduled for a procedure that requires analgesia and/or sedation by any route (intravenous, intramuscular, oral, epidural or intrathecal).
- Patients with an anticipated length of sedation greater than or equal to one hour.
- Patients in the ASA category I through III.
- Patients who only receive propofol, benzodiazepines, and opioids.
Who cannot join
- Age less than 21 years
- Patients whose room air oxygen saturation is <90%
- Patients receiving post-operative positive airway pressure support
- Previous allergic/contact reactions to adhesives
- CHF
- Moderate or severe valvular disease
Show all 13Show fewer
- TIA/CVA
- Carotid stenosis or endarterectomy
- Anemia (HCT if available < 30%)
- Pulmonary hypertension
- Dialysis
- Pregnancy
- Patients unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Avista Adventist Hospital
Louisville, Colorado, 80027
About this study
Official title: Saturation Pattern Detection Prevalence Study Protocol
Patients with Obstructive Sleep Apnea (OSA) have cyclical patterns of lower blood oxygen during sleep because of repeated episodes of upper airway obstruction that cause their breathing to stop. When these patients have surgery, anesthetic drugs may worsen these patterns of lower blood oxygen. This study monitors ten patients at high risk for OSA and ten patients at low risk for OSA during surgery. Patterns of lower oxygen saturations should arise in the high risk group but not the low risk group.
Read the detailed description
Patients with Obstructive Sleep Apnea (OSA) have episodes of upper airway obstruction during sleep which have been shown to be accompanied by multiple oxygen desaturations followed by short recovery intervals until rising PaCO2 causes sleep disruption/rescue arousal. In the postoperative and conscious sedation arena, these patterns can deteriorate from a stable pattern to a severely unstable pattern which may go unrecognized and lead to an adverse event (respiratory/cardiac arrest; death).
Anesthesia and the higher consumption of analgesics produce a profound reduction in pharyngeal tone, a dampening of both chemoreceptor sensitivity and arousal/rescue response. Thus the first 48 hours post operatively presents a vulnerable period. Respiratory disturbances are more prominent - respiratory arrest and hypopnea being the main adverse occurrences during this period.
An algorithm has been developed that monitors saturation and indicates repetitive reductions in airflow through the upper airway and into the lungs. Presence of this pattern in the procedural sedation patient population has not been tested for its prevalence. This study will monitor patients during surgery to determine if this pattern occurs in this hospital setting.
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive Sleep Apnea, Pulse Oximetry
- Medical subject headings
- Sleep Apnea, Obstructive
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 |
|---|---|---|
| Obstructive Sleep Apnea | Surgery patients at high risk for Obstructive Sleep Apnea | |
| Surgery Patients | Surgery patients at low risk for Obstructive Sleep Apnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow
Saturation Pattern Detection (SPD) is the pattern of oxygen saturation values plotted against time that occurs when patients have cyclical reduced air movement during breathing. Their blood oxygen level decreases and increases as they slow and increase their breathing.
Measured: 3 hours
Number of Participants Requiring Airway Support
Drugs during surgery may cause the throat to relax and block breathing. To treat this, the caregiver administers airway support. Airway support is moving the jaw forward, inserting a plastic tube (nasal-oral airway) or applying a mask with positive pressure.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2010 (estimated)
- Study startJul 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Mecca, MD, Study chair, Medtronic - MITG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098851
- Sponsor's protocol ID
- COV-MO-PO-1000
- Status last verified
- Aug 2014
- First submitted
- 31 Mar 2010
- Last updated
- 7 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saturation Pattern Detection Prevalence Study Protocol
- ClinicalTrials.gov ID
- NCT01098851
- Acronym / sponsor ID
- COV-MO-PO-1000
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive Sleep Apnea, Pulse Oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 5 Apr 2010 (estimated)
- Results
- Posted 29 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with Obstructive Sleep Apnea (OSA) have cyclical patterns of lower blood oxygen during sleep because of repeated episodes of upper airway obstruction that cause their breathing to stop. When these patients have surgery, anesthetic drugs may worsen these patterns of lower blood oxygen. This study monitors ten patients at high risk for OSA and ten patients at low risk for OSA during surgery. Patterns of lower oxygen saturations should arise in the high risk group but not the low risk group.
Detailed description
Patients with Obstructive Sleep Apnea (OSA) have episodes of upper airway obstruction during sleep which have been shown to be accompanied by multiple oxygen desaturations followed by short recovery intervals until rising PaCO2 causes sleep disruption/rescue arousal. In the postoperative and conscious sedation arena, these patterns can deteriorate from a stable pattern to a severely unstable pattern which may go unrecognized and lead to an adverse event (respiratory/cardiac arrest; death).
Anesthesia and the higher consumption of analgesics produce a profound reduction in pharyngeal tone, a dampening of both chemoreceptor sensitivity and arousal/rescue response. Thus the first 48 hours post operatively presents a vulnerable period. Respiratory disturbances are more prominent - respiratory arrest and hypopnea being the main adverse occurrences during this period.
An algorithm has been developed that monitors saturation and indicates repetitive reductions in airflow through the upper airway and into the lungs. Presence of this pattern in the procedural sedation patient population has not been tested for its prevalence. This study will monitor patients during surgery to determine if this pattern occurs in this hospital setting.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea | – | –Surgery patients at high risk for Obstructive Sleep Apnea |
| Surgery Patients | – | –Surgery patients at low risk for Obstructive Sleep Apnea |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care hospital
Key inclusion criteria (5 listed)
- Age greater than 21 years
- Patients scheduled for a procedure that requires analgesia and/or sedation by any route (intravenous, intramuscular, oral, epidural or intrathecal).
- Patients with an anticipated length of sedation greater than or equal to one hour.
- Patients in the ASA category I through III.
- Patients who only receive propofol, benzodiazepines, and opioids.
Key exclusion criteria (13 listed)
- Age less than 21 years
- Patients whose room air oxygen saturation is <90%
- Patients receiving post-operative positive airway pressure support
- Previous allergic/contact reactions to adhesives
- CHF
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
Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow
Time frame: 3 hours
Saturation Pattern Detection (SPD) is the pattern of oxygen saturation values plotted against time that occurs when patients have cyclical reduced air movement during breathing. Their blood oxygen level decreases and increases as they slow and increase their breathing.
Number of Participants Requiring Airway Support
Time frame: 3 hours
Drugs during surgery may cause the throat to relax and block breathing. To treat this, the caregiver administers airway support. Airway support is moving the jaw forward, inserting a plastic tube (nasal-oral airway) or applying a mask with positive pressure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Sleep Apnea, Obstructive
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Roger Mecca, MD study chair
Medtronic - MITG
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 Sleep Apnea, Obstructive, run by Medtronic - MITG at 1 site in United States.
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 5 inclusion and 13 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 7 Aug 2014. 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow (time frame: 3 hours). The study lists 2 primary outcomes in all. 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 7 Aug 2014.