Skip to main content
OpenTrials
Completed

NCT Number: NCT02554110

Peripheral Nerve Stimulation to Reduce Hypoxic Events

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stimulator active device

Device

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

Stimulator sham Device

Device

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

Primary outcomes

  1. Area Under the Curve for oxygen saturation (SpO2%)

    Time frame: One hour

Secondary outcomes

  1. Frequency of desaturation episodes

    Time frame: One hour

  2. Frequency of nursing interventions

    Time frame: One hour

  3. Frequency of Adverse Events

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 18, 2015
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.