Obstructive Sleep Apnea
Conditions
Brief summary
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.
Detailed description
There is no further detailed description available.
Interventions
None listed
Sponsors
Medtronic - MITG
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years undergoing thoracic, vascular, head and neck, gynecological, urological, general, orthopedic, and plastic surgery. * Patient must require analgesia and/or sedation postoperatively by any route (intravenous, intramuscular, oral, epidural or intrathecal) for the duration of the study * Postoperative patients with at least one anticipated over night stay on the general ward with a minimum length of 14 hrs. * Patients in the ASA category 1-4 * Patients at high risk for obstructive sleep apnea (OSA) as identified by the STOP-Bang Questionnaire or patients previously diagnosed with OSA and not using a CPAP device. (No screening with STOP needed for these patients.) * Spontaneous breathing
Exclusion criteria
* Age less than 18 years * Patients receiving or anticipated to receive postoperative positive airway pressure support * Previous allergic/contact reactions to adhesives * Patients unable to give informed consent * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data. | 12 hour after released from the recovery room | Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure. | 12 hours after discharge form the recovery room | The number of patients with a positive repetitive reduction in nasal airflow which correlates with positive oxygen desaturation pattern as measured by photoplethysmography sensors. |
Countries
Canada
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Adult Surgical Patients At Risk for Obstructive Sleep Apnea Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Adult Surgical Patients At Risk for Obstructive Sleep Apnea |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 49 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants |
| Age, Continuous | 65.1 years STANDARD_DEVIATION 9.2 |
| Region of Enrollment Canada | 100 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
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
Population: All patients with complete data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 participants |
Secondary
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
Population: All patients with a positive repetitive reduction in nasal airflow.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 participants |