N/A
N=100
Oxygen Saturation Patterns in Post-Op Patients at Risk for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT01078207 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data. — 30 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data. |
30 | — |
| SECONDARY Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure. |
20 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01078207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.