Peripheral Nerve Stimulation to Reduce Hypoxic Events

Mayo Clinic

Status: Completed

Conditions: Hypoventilation; Apnea; Hypoxemia

Treatments: Device: Stimulator sham Device; Device: Stimulator active device

Study type: Interventional

Funder types: Other

Identifiers

NCT02554110

13-003533

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Stimulator Active Device

Experimental group

Description:

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.

Treatment:

Device: Stimulator active device

Stimulator Sham Device

Sham Comparator group

Description:

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.

Treatment:

Device: Stimulator sham Device