Peripheral Nerve Stimulation to Reduce Hypoxic Events

Not Applicable

Completed

• Conditions: Apnea; Hypoventilation; Hypoxemia
• Interventions: Device: Stimulator active device; Device: Stimulator sham Device

• Registration Number: NCT02554110
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Study Start: 2015-10-12
• Primary Completion: 2017-01-19
• Study Completion: 2017-01-19
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-13
• Last Update Posted: 2018-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stimulator Active Device	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.
Stimulator Sham Device	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.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve for oxygen saturation (SpO2%)	One hour

Secondary Outcome Measures

Name	Time	Method
Frequency of Adverse Events	72 hours
Frequency of desaturation episodes	One hour
Frequency of nursing interventions	One hour

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States