ApneaNCT02554110
Peripheral Nerve Stimulation to Reduce Hypoxic Events
A study testing Stimulator active device in people with Apnea and Hypoventilation, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apnea, Hypoventilation, Hypoxemia
- What is being tested?
- Stimulator active device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2015to 19 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
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.
Read the 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.
- Conditions
- Apnea, Hypoventilation, Hypoxemia
- Being tested
- Stimulator active device, Stimulator sham Device
- Medical subject headings
- Apnea, Hypoventilation, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulator active deviceDevice
This is a stimulator active device that delivers peripheral nerve stimulation in conjunction with pulse oximetry information.
Stimulator sham DeviceDevice
This is an stimulator sham device that is not providing peripheral nerve stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Stimulator sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve for oxygen saturation (SpO2%)
Measured: One hour
Secondary outcomes (3)
Frequency of desaturation episodes
Measured: One hour
Frequency of nursing interventions
Measured: One hour
Frequency of Adverse Events
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study start12 Oct 2015
- Primary completion19 Jan 2017
- Study completion19 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ApneaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hugh M. Smith, Mayo Clinic
- Investigators
- Hugh Smith, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554110
- Sponsor's protocol ID
- 13-003533
- Status last verified
- Nov 2018
- First submitted
- 17 Sep 2015
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31338807
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02554110
- Acronym / sponsor ID
- 13-003533
- Conditions
- Apnea, Hypoventilation, Hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Oct 2015 (actual)
- Primary completion
- 19 Jan 2017 (actual)
- Study completion
- 19 Jan 2017 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulator Active Device | Experimental | Device: Stimulator active deviceIntervention: 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. |
| Stimulator Sham Device | Sham comparator | Device: Stimulator sham DeviceNo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimulator active deviceThis is a stimulator active device that delivers peripheral nerve stimulation in conjunction with pulse oximetry information. | Device | Stimulator Active Device |
| Stimulator sham DeviceThis is an stimulator sham device that is not providing peripheral nerve stimulation. | Device | Stimulator Sham Device |
Primary outcome
Area Under the Curve for oxygen saturation (SpO2%)
Time frame: One hour
3 secondary outcomes
Frequency of desaturation episodes
Time frame: One hour
Frequency of nursing interventions
Time frame: One hour
Frequency of Adverse Events
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Derived from this study: PubMed 31338807Smith 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugh Smith, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulator active device in people with Apnea and Hypoventilation, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve for oxygen saturation (SpO2%) (time frame: One hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02554110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.