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Clinical Trials/ISRCTN89522367
ISRCTN89522367
Completed
Phase 1

A randomized control trial of peripheral nerve stimulation as an adjunct to standard monitoring to reduce hypoxemic events during the post-operative recovery period

Mayo Clinic0 sites100 target enrollmentSeptember 17, 2015

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hypoxemia
Sponsor
Mayo Clinic
Enrollment
100
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 17, 2015
End Date
February 29, 2016
Last Updated
7 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Aged 18 years or over
  • 2\. Able to provide written informed consent
  • 3\. At high risk for undiagnosed obstructive sleep apnea
  • 4\. Having gynecological, colorectal, orthopedic surgery, and urologic surgeries
  • 5\. Baseline oxygen saturation on room air \> 96%

Exclusion Criteria

  • 1\. Peripheral neuropathy involving the upper extremities
  • 2\. Procedures requiring direct admission to the ICU or any site other than the PACU from the OR
  • 3\. Diagnosed OSA and / or use of CPAP / BiPAP in the PACU
  • 4\. Presence of any implantable electric devices, including internal defibrillators, pacemakers, or left ventricular assist device (LVAD)
  • 5\. Post\-procedure temperature \< 35\.5 Celsius or evidence of vasoconstriction
  • 6\. Presence of metal hardware in either arm or in either shoulder
  • 7\. Patients lacking access to the bare skin on an arm after surgery
  • 8\. History of atrial fibrillation
  • 9\. History of bundle branch block
  • 10\. Females from menarche to menopause that do not have a current negative pregnancy test or surgical history preventing pregnancy.

Outcomes

Primary Outcomes

Not specified

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