Apnea, Hypoventilation, Hypoxemia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEStimulator active device
This is a stimulator active device that delivers peripheral nerve stimulation in conjunction with pulse oximetry information.
DEVICEStimulator sham Device
This is an stimulator sham device that is not providing peripheral nerve stimulation.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Curve for oxygen saturation (SpO2%) | One hour |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of desaturation episodes | One hour |
| Frequency of nursing interventions | One hour |
| Frequency of Adverse Events | 72 hours |
Countries
United States
Outcome results
None listed