Trial Outcomes & Findings for Oxygen Saturation Patterns in Post-Op Patients at Risk for Obstructive Sleep Apnea (NCT NCT01078207)
NCT ID: NCT01078207
Last Updated: 2014-08-07
Results Overview
Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects
COMPLETED
100 participants
12 hour after released from the recovery room
2014-08-07
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxygen Saturation Patterns in Post-Op Patients at Risk for Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
Adult Surgical Patients At Risk for Obstructive Sleep Apnea
n=100 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
49 Participants
n=93 Participants
|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 9.2 • n=93 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
100 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 12 hour after released from the recovery roomPopulation: All patients with complete data were analyzed.
Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects
Outcome measures
| Measure |
Adult Surgical Patients At Risk for Obstructive Sleep Apnea
n=83 Participants
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.
|
|---|---|
|
Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data.
|
30 participants
|
SECONDARY outcome
Timeframe: 12 hours after discharge form the recovery roomPopulation: All patients with a positive repetitive reduction in nasal airflow.
The number of patients with a positive repetitive reduction in nasal airflow which correlates with positive oxygen desaturation pattern as measured by photoplethysmography sensors.
Outcome measures
| Measure |
Adult Surgical Patients At Risk for Obstructive Sleep Apnea
n=30 Participants
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.
|
|---|---|
|
Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure.
|
20 participants
|
Adverse Events
Adult Surgical Patients At Risk for Obstructive Sleep Apnea
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Fran Haury, RRT Research Coordinator, Clinical Affairs
Covidien
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60