Oxygen DeficiencyNCT03128372

Validation of Next Generation Cerebral and Tissue Oximeter

A study testing Desaturation in people with Oxygen Deficiency, run by Medtronic - MITG at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation. Read more about this study

Who is it for?: Ages 18 to 46 yearsHealthy volunteers can take part
Conditions the study is for: Oxygen Deficiency
What is being tested?: Desaturation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 22 May 2017to 19 Jul 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 46 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy, male or female subjects between the ages of 18 to ≤46 years;
Completion of a health screening for a medical history by a licensed physician, nurse practitioner or physician assistant;
Minimum weight 40kg;
BMI within range 18.0 - 30.0.

Who cannot join

Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) [self-reported];
Prior known severe allergies to medical grade adhesive/tape (Band-Aid) [self-reported];
Taking any medication other than birth control [self-reported];
Is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study [self-reported];
Has a negative Allen's Test to confirm non-patency of the collateral artery [clinical assessment by PI or delegate];
Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure [self-reported];

Show all 15Show fewer

Is female with a positive pregnancy test [serum or urine], or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breastfeeding;
Has anemia [lab values specific for gender];
Has a history of sickle cell trait or thalassemia [self-reported];
Has an abnormal hemoglobin electrophoresis test [lab measurement];
Has a positive urine cotinine test or urine drug screen or oral ethanol test [POC testing];
Has a room air saturation less than 95% by pulse oximetry [measurement by PI or delegate];
Has a clinically significant abnormal ECG [assessment by PI or delegate];
Has a clinically significant abnormal pulmonary function test via spirometry [assessment by PI or delegate];
Has a COHb greater than 3%, or MetHb greater than 2% [measured by venous blood sample co-oximetry]

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Hospital, HPPL
Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Validation of Next Generation INVOS NIRS Cerebral and Tissue Oximeter to Measure Cerebral and Somatic Tissue Oxygen Saturation in Healthy Volunteers

This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation.

Conditions: Oxygen Deficiency
Being tested: Desaturation
Medical subject headings: Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DesaturationDevice
Also called Cerebral and Tissue Oximeter
The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.

Study groups in NCT03128372
Study group	Role	What they receive
Desaturation	Experimental	Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%. Receives: Device: Desaturation

What is being measured

The primary outcome is the main question the study is designed to answer.

Validated the Next Generation Oximeter
Cerebral overall mean bias (percentage saturation) defined as the average of the differences between the regional saturation (rSO2) value and (fSO2) value obtained from simultaneous arterial and jugular venous blood samples. Cerebral trending is defined as the measurement of changes in regional saturation (rSO2) under conditions of changing fSO2. Cerebral trending mean bias is the average difference between changes in rSO2 values compared against changes in fSO2. Somatic trending mean bias is defined the same as Cerebral trending mean bias except for the location of measurement on the subjects and for Somatic trending mean bias, rS02 was compared to rSO2 on a commercially-available regional oximetry monitor. The smaller value the better performance.
Measured: Data collected from individual participant over 4 hour timeframe.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 201719 Jul 2017

First posted25 Apr 2017
Study start22 May 2017
Primary completion19 Jul 2017
Study completion19 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Oxygen DeficiencyStudies of the same condition, open and under way.
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: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03128372
Sponsor's protocol ID: MDT16010MAVJB3
Status last verified: Oct 2018
First submitted: 5 Apr 2017
Last updated: 9 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingEarly Phase 1
Multiparametric Metabolic and Hypoxic PET/MRI Imaging Substudy in Gliomas
Glioma
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Impact of Closed PBSC Collection With Reduced Gas-Phase Oxygen Exposure on Graft Quality and Early Engraftment in Allo-HSCT
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Oxygen Deficiency
RecruitingObservational study
Predict Severe Traumatic Brain Injury
Traumatic Brain Injury
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)

All Oxygen Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation of Next Generation INVOS NIRS Cerebral and Tissue Oximeter to Measure Cerebral and Somatic Tissue Oxygen Saturation in Healthy Volunteers
ClinicalTrials.gov ID: NCT03128372
Acronym / sponsor ID: MDT16010MAVJB3
Conditions: Oxygen Deficiency
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: 22 May 2017 (actual)
Primary completion: 19 Jul 2017 (actual)
Study completion: 19 Jul 2017 (actual)
First posted: 25 Apr 2017 (actual)
Results: Posted 9 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Desaturation	Experimental	Device: DesaturationVolunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.

Who may qualify

Ages: 18 to 46 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy, male or female subjects between the ages of 18 to ≤46 years;
Completion of a health screening for a medical history by a licensed physician, nurse practitioner or physician assistant;
Minimum weight 40kg;
BMI within range 18.0 - 30.0.

Key exclusion criteria (15 listed)

Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) [self-reported];
Prior known severe allergies to medical grade adhesive/tape (Band-Aid) [self-reported];
Taking any medication other than birth control [self-reported];
Is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study [self-reported];
Has a negative Allen's Test to confirm non-patency of the collateral artery [clinical assessment by PI or delegate];

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
DesaturationAlso: Cerebral and Tissue OximeterThe delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.	Device	Desaturation

Primary outcome

Validated the Next Generation Oximeter
Time frame: Data collected from individual participant over 4 hour timeframe.
Cerebral overall mean bias (percentage saturation) defined as the average of the differences between the regional saturation (rSO2) value and (fSO2) value obtained from simultaneous arterial and jugular venous blood samples. Cerebral trending is defined as the measurement of changes in regional saturation (rSO2) under conditions of changing fSO2. Cerebral trending mean bias is the average difference between changes in rSO2 values compared against changes in fSO2. Somatic trending mean bias is defined the same as Cerebral trending mean bias except for the location of measurement on the subjects and for Somatic trending mean bias, rS02 was compared to rSO2 on a commercially-available regional oximetry monitor. The smaller value the better performance.

Results and safety

Results posted to the registry on 9 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Desaturation	32	32

Primary outcome: Validated the Next Generation Oximeter

Time frame: Data collected from individual participant over 4 hour timeframe.. Mean (Standard Deviation). Unit: Percentage saturation

Measure	Desaturation n = 32
Cerebral Overall Mean Bias	1.22 (5.92)
Cerebral Overall Trending Mean Bias	0.83 (3.08)
Somatic Overall Trending Mean Bias	0.09 (1.73)

Adverse events

Time frame: 48 hours post study procedure (desaturation). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Desaturation	0 of 32 (0%)	2 of 32 (6.3%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Oxygen Deficiency

Not yet recruitingEarly Phase 1
Multiparametric Metabolic and Hypoxic PET/MRI Imaging Substudy in Gliomas
Glioma
Not yet recruiting
Impact of Closed PBSC Collection With Reduced Gas-Phase Oxygen Exposure on Graft Quality and Early Engraftment in Allo-HSCT
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Oxygen Deficiency
RecruitingObservational study
Predict Severe Traumatic Brain Injury
Traumatic Brain Injury
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)

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.

Julia Katilius study director

Medtronic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Desaturation in people with Oxygen Deficiency, run by Medtronic - MITG 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 4 inclusion and 15 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 9 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. 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?

Yes. Results are posted in the registry (first posted 9 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Validated the Next Generation Oximeter (time frame: Data collected from individual participant over 4 hour timeframe.). 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 NCT03128372.

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 9 Nov 2018.