Expired Study
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Rochester, Minnesota 55905


Purpose:

This study is designed to determine if using peripheral nerve stimulation in conjunction with pulse oximetry as an adjunct to traditional monitoring in the PACU reduces the frequency and severity of sedation related apnea and hypoxic events.


Study summary:

The primary effectiveness objective is to determine if transcutaneous stimulation will generate a respiratory response capable of reducing the extent and duration of oxygen desaturations in patients with presumed risk of obstructive sleep apnea (OSA) who have received some form of anesthesia or sedation. The primary safety objective is the demonstration that the peripheral nerve stimulation is safe for the use of preventing or reducing the sedation related hypoxemic events.


Criteria:

Inclusion Criteria - Males and females > 18 yrs old - Flemon's Score > 15 - Able to provide written informed consent - Having gynecological, colorectal, orthopedic surgery, and urologic surgeries - Baseline oxygen saturation on room air > 96% Exclusion Criteria: - Peripheral neuropathy involving the upper extremities - Procedures requiring direct admission to the ICU or any site other than the post-anesthesia care unit from the OR - Diagnosed obstructive sleep apnea (OSA) and / or use of continuous positive airway pressure (CPAP) or biphasic positive airway pressure (BiPAP) in the PACU. - Presence of any implantable electric devices, including internal defibrillators, pacemakers, or left ventricular assist device (LVAD) - Post-procedure temperature < 35.5 Celsius or evidence of vasoconstriction - Presence of metal hardware in either arm or in either shoulder - Patients lacking access to the bare skin on an arm after surgery. - History of atrial fibrillation - History of bundle branch block - Females from menarche to menopause that do not have a current negative pregnancy test or surgical history preventing pregnancy.


NCT ID:

NCT02554110


Primary Contact:

Principal Investigator
Bhargavi Gali, MD
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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