Peripheral Nerve Stimulation to Reduce Hypoxic Events

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

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 Overview

• Status: Completed
• Conditions: Apnea; Hypoventilation; Hypoxemia
• Intervention / Treatment: Device: Stimulator active device; Device: Stimulator sham Device

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Stimulator active device; This is a stimulator active device that delivers peripheral nerve stimulation in conjunction with pulse oximetry information.
Sham Comparator: 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.	Device: Stimulator sham Device; This is an stimulator sham device that is not providing peripheral nerve stimulation.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Hugh Smith, MD, Mayo Clinic

Publications and helpful links

General Publications

• Smith HM, Kilger J, Burkle CM, Schroeder DR, Gali B. Peripheral electrical stimulation reduces postoperative hypoxemia in patients at risk for obstructive sleep apnea: a randomized-controlled trial. Can J Anaesth. 2019 Nov;66(11):1296-1309. doi: 10.1007/s12630-019-01451-3. Epub 2019 Jul 23.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2015
• Primary Completion (Actual): January 19, 2017
• Study Completion (Actual): January 19, 2017

Study Registration Dates

• First Submitted: September 17, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoxia; Hypoventilation
• Other Study ID Numbers: 13-003533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No