Peripheral Nerve Stimulation to Reduce Hypoxic Events

Hypoxemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554110
• Other study ID #: 13-003533
• Status: Completed
• Phase: N/A
• Start date: October 12, 2015
• Est. completion date: January 19, 2017

Study information

• Verified date: November 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 19, 2017
• Est. primary completion date: January 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Hypoventilation
• Hypoxemia
• Hypoxia

Intervention

Device:
• Stimulator active device
This is a stimulator active device that delivers peripheral nerve stimulation in conjunction with pulse oximetry information.
• Stimulator sham Device
This is an stimulator sham device that is not providing peripheral nerve stimulation.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve for oxygen saturation (SpO2%)		One hour
Secondary	Frequency of desaturation episodes		One hour
Secondary	Frequency of nursing interventions		One hour
Secondary	Frequency of Adverse Events		72 hours