Peripheral Nerve Stimulation to Reduce Hypoxic Events

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-12

Study Completion Date

2017-01-19

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.

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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.

Conditions

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Apnea Hypoventilation Hypoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Stimulator Active Device

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.

Group Type EXPERIMENTAL

Stimulator active device

Intervention Type DEVICE

This is a stimulator active device that delivers peripheral nerve stimulation in conjunction with pulse oximetry information.

Stimulator Sham Device

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.

Group Type SHAM_COMPARATOR

Stimulator sham Device

Intervention Type DEVICE

This is an stimulator sham device that is not providing peripheral nerve stimulation.

Interventions

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Stimulator active device

This is a stimulator active device that delivers peripheral nerve stimulation in conjunction with pulse oximetry information.

Intervention Type DEVICE

Stimulator sham Device

This is an stimulator sham device that is not providing peripheral nerve stimulation.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No