An observational study in Obstructive Sleep Apnea, sponsored by Medtronic - MITG. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-07.
Sponsored by Medtronic - MITG · Observational
This study will include patients who have major surgery and are at risk for or have been diagnosed with sleep apnea. The patients will be monitored the night after surgery for repeating episodes of reduced breathing and oxygen levels. The study will determine if episodes of decreased breathing are reflected in the oxygen monitor.
There is no further detailed description available.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 100 is close to the median of 106 across 386 observational studies indexed under Apnea.
Browse Apnea studies →Medtronic - MITG is the lead sponsor of 176 studies on the registry; 5 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients older than 18 years undergoing thoracic, vascular, head and neck, gynecological, urological, general, orthopedic, and plastic surgery.
Exclusion Criteria:
Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data.
Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects
Time frame: 12 hour after released from the recovery room
Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure.
The number of patients with a positive repetitive reduction in nasal airflow which correlates with positive oxygen desaturation pattern as measured by photoplethysmography sensors.
Time frame: 12 hours after discharge form the recovery room
From Feb 2010 to Oct 2010 adults at high risk for obstructive sleep apnea scheduled for general surgery requiring analgesia with an expected over night hospital stay were recruited from the hospital clinic.
| Milestone | Adult Surgical Patients At Risk for Obstructive Sleep Apnea |
|---|---|
| Started | 100 |
| Completed | 100 |
| Not completed | 0 |
Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects
| participants | Adult Surgical Patients At Risk for Obstructive Sleep Apnea |
|---|---|
| Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data. | 30 |
The number of patients with a positive repetitive reduction in nasal airflow which correlates with positive oxygen desaturation pattern as measured by photoplethysmography sensors.
| participants | Adult Surgical Patients At Risk for Obstructive Sleep Apnea |
|---|---|
| Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure. | 20 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adult Surgical Patients At Risk for Obstructive Sleep Apnea | — | 0/100 (0%) | 0/100 (0%) |
| Age, Categorical(Participants) | Adult Surgical Patients At Risk for Obstructive Sleep Apnea |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 51 |
| >=65 years | 49 |
| Age, Continuous(years) | Adult Surgical Patients At Risk for Obstructive Sleep Apnea |
|---|---|
| Mean | 65.1 ± 9.2 |
| Sex: Female, Male(Participants) | Adult Surgical Patients At Risk for Obstructive Sleep Apnea |
|---|---|
| Female | 22 |
| Male | 78 |
| Region of Enrollment(participants) | Adult Surgical Patients At Risk for Obstructive Sleep Apnea |
|---|---|
| Canada | 100 |
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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