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Tactile stimulus for the prevention of low blood oxygen immediately after surgery

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN89522367
Enrollment
100
Registered
2015-09-17
Start date
2015-09-18
Completion date
Unknown
Last updated
2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemia Circulatory System Hypoxemia

Interventions

Patients are randomly allocated into two groups. For participants in the control group, a sham device is used which delivers no peripheral nerve stimulation. For those in the intervention group, the o

Sponsors

Mayo Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Cumulative area under the curve with SpO2 below 90% over one hour

Secondary

MeasureTime frame
1. Lowest recorded Sp02 over one hour 2. Cummulative time below 90% over one hour 3. Number of nursing interventions in each group

Countries

United States of America

Contacts

Public ContactRichard Hinds
hinds.richard@mayo.edu+1 507 538 4344

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026