NCT02554110

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Apnea
• Hypoventilation
• Hypoxemia

Interventions

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

Timeline

• Start date: 2015-10-12
• Primary completion: 2017-01-19
• Completion: 2017-01-19
• First posted: 2015-09-18
• Last updated: 2018-11-15

Locations

1 site across 1 country: United States