Back to results

Peripheral Nerve Stimulation to Reduce Hypoxic Events

Primary Purpose

Apnea, Hypoventilation, Hypoxemia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stimulator active device

Stimulator sham Device

About this trial

This is an interventional treatment trial for Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Stimulator Active Device

Stimulator Sham Device

Arm 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.

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.

Outcomes

Primary Outcome Measures

Area Under the Curve for oxygen saturation (SpO2%)

Secondary Outcome Measures

Frequency of desaturation episodes

Frequency of nursing interventions

Frequency of Adverse Events

Full Information

NCT ID

NCT02554110

First Posted

September 17, 2015

Last Updated

November 13, 2018

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02554110

Brief Title

Peripheral Nerve Stimulation to Reduce Hypoxic Events

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

October 12, 2015 (Actual)

Primary Completion Date

January 19, 2017 (Actual)

Study Completion Date

January 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Apnea, Hypoventilation, Hypoxemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stimulator Active Device

Arm Type

Experimental

Arm Description

Arm Title

Stimulator Sham Device

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Stimulator active device

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Stimulator sham Device

Intervention Description

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

Primary Outcome Measure Information:

Title

Area Under the Curve for oxygen saturation (SpO2%)

Time Frame

One hour

Secondary Outcome Measure Information:

Title

Frequency of desaturation episodes

Time Frame

One hour

Title

Frequency of nursing interventions

Time Frame

One hour

Title

Frequency of Adverse Events

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hugh Smith, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31338807

Citation

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.

Results Reference

derived

Learn more about this trial

Peripheral Nerve Stimulation to Reduce Hypoxic Events

We'll reach out to this number within 24 hrs