Peripheral Nerve Stimulation to Reduce Hypoxic Events

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Control Trial of the Oxistimulator as an Adjunct to Standard Practice to Decrease Extent and Duration of Oxygen Desaturation in Adult Patients Who Have Received Anesthetics or Are Receiving Sedating Medications

Conditions
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Apnea, Hypoventilation, Hypoxemia

Intervention / Treatment
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* Device: Stimulator active device
* Device: Stimulator sham Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulator Active Device<br>Intervention: This intervention arm will use a Stimulator Active Device peripheral nerve stimulation. Participants will receive a cutaneous stimuli in response to oxygen desaturations in postoperative surgical patients. | Device: Stimulator active device<br>* This is a stimulator active device that delivers peripheral nerve stimulation in conjunction with pulse oximetry information.<br>|
| Sham Comparator: Stimulator Sham Device<br>No intervention: This arm will use a Stimulator Sham Device peripheral nerve stimulation.Participants will not receive a cutaneous stimuli in response to oxygen desaturations in postoperative surgical patients. | Device: Stimulator sham Device<br>* This is an stimulator sham device that is not providing peripheral nerve stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve for oxygen saturation (SpO2%) |  | One hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of desaturation episodes |  | One hour | 
| Frequency of nursing interventions |  | One hour | 
| Frequency of Adverse Events |  | 72 hours |