N/A Completed N=21

Oxygen Saturation Monitoring During Surgery

Sleep Apnea, Obstructive

Source: ClinicalTrials.gov NCT01098851 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2011

Primary outcomePrimary: Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow — 4; 0 Participants

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.