Clinical trial NCT02554110: Peripheral Nerve Stimulation to Reduce Hypoxic Events
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apnea
Hypoventilation
Hypoxemia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Area Under the Curve for oxygen saturation (SpO2%)
timeFrame: One hour
Secondary outcomes:
measure: Frequency of desaturation episodes
timeFrame: One hour
measure: Frequency of nursing interventions
timeFrame: One hour
measure: Frequency of Adverse Events
timeFrame: 72 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Hugh Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith HM, Kilger J, Burkle CM, Schroeder DR, Gali B. Peripheral electrical stimulation reduces postoperative hypoxemia in patients at risk for obstructive sleep apnea: a randomized-controlled trial. Can J Anaesth. 2019 Nov;66(11):1296-1309. doi: 10.1007/s12630-019-01451-3. Epub 2019 Jul 23.