Peripheral Nerve Stimulation to Reduce Hypoxic Events

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02554110

Collaborator

(none)

Enrollment

Location

Arms

15.3

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Apnea Hypoventilation Hypoxemia	Device: Stimulator active device Device: Stimulator sham Device	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 12, 2015

Actual Primary Completion Date :

Jan 19, 2017

Actual Study Completion Date :

Jan 19, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Area Under the Curve for oxygen saturation (SpO2%) [One hour]

Secondary Outcome Measures

Frequency of desaturation episodes [One hour]
Frequency of nursing interventions [One hour]
Frequency of Adverse Events [72 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Hugh Smith, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hugh M. Smith, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT02554110

Other Study ID Numbers:

13-003533

First Posted:

Sep 18, 2015

Last Update Posted:

Nov 15, 2018

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypoventilation

Hypoxia

Study Results

No Results Posted as of Nov 15, 2018