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

Phase 1

Completed

• Conditions: Hypoxemia; Circulatory System

• Registration Number: ISRCTN89522367
• Lead Sponsor: Mayo Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-17
• Study Completion: 2016-02-29
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative area under the curve with SpO2 below 90% over one hour

Secondary Outcome Measures

Name	Time	Method
<br> 1. Lowest recorded Sp02 over one hour<br> 2. Cummulative time below 90% over one hour<br> 3. Number of nursing interventions in each group<br>