NCT02554110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

October 12, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2017

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

1.3 years

First QC Date

September 17, 2015

Last Update Submit

November 13, 2018

Conditions

ApneaHypoventilationHypoxemia

Outcome Measures

Primary Outcomes (1)

  • Area Under the Curve for oxygen saturation (SpO2%)

    One hour

Secondary Outcomes (3)

  • Frequency of desaturation episodes

    One hour

  • Frequency of nursing interventions

    One hour

  • Frequency of Adverse Events

    72 hours

Study Arms (2)

Stimulator Active Device

EXPERIMENTAL

Intervention: This intervention arm will use a Stimulator Active Device peripheral nerve stimulation. Participants will receive a cutaneous stimuli in response to oxygen desaturations in postoperative surgical patients.

Device: Stimulator active device

Stimulator Sham Device

SHAM COMPARATOR

No intervention: This arm will use a Stimulator Sham Device peripheral nerve stimulation.Participants will not receive a cutaneous stimuli in response to oxygen desaturations in postoperative surgical patients.

Device: Stimulator sham Device

Interventions

Stimulator active deviceDEVICE

This is a stimulator active device that delivers peripheral nerve stimulation in conjunction with pulse oximetry information.

Stimulator Active Device
Stimulator sham DeviceDEVICE

This is an stimulator sham device that is not providing peripheral nerve stimulation.

Stimulator Sham Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 31338807DERIVED

MeSH Terms

Conditions

ApneaHypoventilationHypoxia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Insufficiency

Study Officials

  • Hugh Smith, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 17, 2015

First Posted

September 18, 2015

Study Start

October 12, 2015

Primary Completion

January 19, 2017

Study Completion

January 19, 2017

Last Updated

November 15, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)