N/A
N=21
Oxygen Saturation Monitoring During Surgery
Sleep Apnea, Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT01098851 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow — 4; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow |
4; 0 | — |
| PRIMARY Number of Participants Requiring Airway Support |
8; 4 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- TIA/CVA
- Carotid stenosis or endarterectomy
- Anemia (HCT if available < 30%)
- Pulmonary hypertension
- Dialysis
- Pregnancy
- Patients unable to give informed consent
Data sourced from ClinicalTrials.gov (NCT01098851). 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.