Hypoxemia Clinical Trial
Official 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
Verified date | November 2018 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | January 19, 2017 |
Est. primary completion date | January 19, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under the Curve for oxygen saturation (SpO2%) | One hour | ||
Secondary | Frequency of desaturation episodes | One hour | ||
Secondary | Frequency of nursing interventions | One hour | ||
Secondary | Frequency of Adverse Events | 72 hours |
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