HypoxiaNCT04559763
SpO2 Accuracy Validation of the OxySoft Sensor Via Reference CO-Oximetry Motion Study
An observational study of Hypoxia and Desaturation of Blood, run by Medtronic - MITG at 1 site in United States.
Trial summary
SpO2 (oxygen saturation) and pulse rate accuracy of pulse oximetry equipment, OxySoft Sensor/N-600x and OxySoft Sensor/N-395, continuous measure of arterial oxygen saturation during hypoxic state throughout motion and non-motion conditions under one system configuration. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Desaturation of Blood
- What is being tested?
- Introduction of Motion conditions: tapping or rubbing
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2020to 21 Aug 2020
- Phase
- Observational
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will be a minimum of twelve subjects, ranging in pigmentation from light to dark to skin tones including subjects with deep pigmentation and the subject selection will be an equitable distribution of males and females.
Who may be able to join
- Subject must have the ability to understand and provide written informed consent
- Adult subjects 18 to 50 years of age.
- Subject must be willing and able to comply with study procedures and duration.
- Subject is a non-smoker or who has not smoked within 2 days prior to the study.
- Male or female of any race.
- Cleared same day Health Assessment form and health screening.
- Subject demographics include a range of skin pigmentations, including at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger.
- Successful Perfusion Index Ulnar/Ulnar+Radial Ratio test showing adequate collateral blood flow.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- Subject is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the sites utilized.)
- Females of childbearing potential, who are pregnant, who are trying to get pregnant or who have a urine test positive for pregnancy on the day of the study
- Subjects with COHb levels >3% as assessed by CO-Oximetry during the procedure
- tHb < 10 g/dl as assessed by CO-Oximetry during the procedure
Show all 51Show fewer
- MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
- Subjects with known respiratory conditions such as:
- uncontrolled / severe asthma,
- flu,
- pneumonia / bronchitis,
- shortness of breath / respiratory distress,
- unresolved respiratory or lung surgery,
- emphysema, COPD, lung disease
- Subjects with known heart or cardiovascular conditions such as:
- Hypertension: systolic >140mmHg, or Diastolic >90mmHg on 3 consecutive readings.
- have had cardiovascular surgery
- Chest pain (angina)
- heart rhythms other than a normal sinus rhythm or
- with respiratory sinus arrhythmia
- previous heart attack
- blocked artery
- unexplained shortness of breath
- congestive heart failure (CHF)
- history of stroke
- transient ischemic attack
- carotid artery disease
- myocardial ischemia
- myocardial infarction
- cardiomyopathy
- Self-reported health conditions as identified in the Health Assessment Form
- diabetes,
- uncontrolled thyroid disease,
- kidney disease / chronic renal impairment,
- history of seizures (except childhood febrile seizures),
- epilepsy,
- history of unexplained syncope,
- recent history of frequent migraine headaches,
- recent symptomatic head injury, within the last 2 months
- Subjects with known clotting disorders
- history of bleeding disorders or personal history of prolonged bleeding from injury
- history of blood clots
- hemophilia
- current use of blood thinner: prescription or daily use of aspirin
- Subjects with Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors
- Subjects with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin
- Arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site. left or right)
- History of clinically significant complications from previous arterial cannulation.
- A radial artery with ten or more arterial cannulations right or left, excludes that site.
- Unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits.
- Other known health condition, should be considered upon disclosure in Health Assessment form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SpO2 Accuracy Validation of the OxySoft Sensor Via Reference CO-Oximetry, During Motion and Non-Motion Conditions in Healthy, Well-Perfused Subjects
SpO2 (oxygen saturation) and pulse rate accuracy of pulse oximetry equipment, OxySoft Sensor/N-600x and OxySoft Sensor/N-395, continuous measure of arterial oxygen saturation during hypoxic state throughout motion and non-motion conditions under one system configuration.
The purpose of this Non-Randomized, Prospective,Observational study is to conduct a hypoxia study to directly compare a prototype OxySoft pulse oximeter system to arterial oxygen saturation.
Read the detailed description
The study utilizes a single-site, physiology laboratory for non-randomized, prospective, interventional studies. The goal is to enroll a range of twelve (12) to sixteen (16) healthy adult volunteers. Subjects may be of any race,ranging in pigmentation from light to dark to meet the study design requirements.
The general purpose of Invasive Controlled Desaturation Studies during motion is to validate the SpO2and pulse rate accuracy in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter during motion conditions. This is achieved through paired observations of SpO2 and SaO2values over the specified SpO2 accuracy range of 70 % to 100 % SaO2 of the prototype pulse oximeter on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted steady-state saturation periods. Arterial blood samples are periodically taken from an indwelling arterial catheter for use in the comparison.
Pulse rate accuracy will be evaluated during the same data collection period as SpO2. Pulse rate will be compared to reference ECG heart rate.In the unlikely event that the ECG monitor malfunctions, the Pulse rate reference may be taken using the average pulse rate value from the transfer standard pulse oximeters. This study is designed to support an FDA submission for pulse rate and saturation accuracy in a diverse subject population during motion conditions over a specified saturation range for the Oxysoft pulse oximetry system.
The FDA Guidance Document for Pulse Oximeters and ISO 80601-2-61 define the accepted guideline for evaluation and documenting the SpO2 accuracy in humans. The OxySoft sensor is not FDA approved for the intended study population, healthy adults. To support the development of Nellcor pulse oximeter systems, data is required to test the performance of the sensors with pulse oximetry systems in the adult patient population. In order to accurately validate sensors, manipulation of oxygen and nitrogen levels through the administration of oxygen and nitrogen gas will occur. Measurements of SpO2and pulse rate accuracy in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter during motion and non-motion conditions will be taken and analyzed to support development of Nellcor technology and support FDA submission.
- Conditions
- Hypoxia, Desaturation of Blood
- Being tested
- Non-Invasive Controlled Hypoxia, Introduction of Motion conditions: tapping or rubbing
- Keywords
- Oxygen Saturation, Invasive Controlled Desaturation
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Controlled HypoxiaDevice
Also called Desaturation, Blood Sampling
Following arterial cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject breathes while simultaneous measurements are recorded from the test pulse oximeters and arterial blood samples are collected at targeted levels of saturation.
Introduction of Motion conditions: tapping or rubbingOther
Standard motions include tapping or rubbing at periodic intervals with amplitudes of 1-2 cm and 1-4 Hz with a random variation in frequency will occur at each plateau. Each plateau will have both an interval of tapping and rubbing. Signals are recorded by a validated, computerized data acquisition system (CAS). The device values are sampled once per second and averaged over the time taken to draw the blood sample, taking into account circulation time delays and differences in device response times
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adult Volunteers | Not described Receives: Device: Non-Invasive Controlled Hypoxia; Other: Introduction of Motion conditions: tapping or rubbing |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate performance of the OxySoft device by measuring oxygen saturation accuracy during motion and non-motion conditions
The primary objective of the study is to investigate the efficacy and performance of the OxySoft device by measuring oxygen saturation accuracy in a diverse subject population during motion and non-motion conditions and over a specified saturation range.
The acceptance criteria for SpO2, on the non-motion hand, across the saturation range of 70-100% when paired with the N-395:
SpO2 OxySoft Sensor/N-395 ± 3% (Arms)
The acceptance criteria for SpO2 during motion conditions, on the motion hand, across the saturation range of 70-100% when paired with the N-600x:
SpO2 OxySoft Sensor/N-600x ± 3% (Arms)
Measured: October 2020
To investigate efficacy and performance of OxySoft device by measuring pulse rate accuracy during motion and non-motion conditions
The secondary objective of the study is to investigate the efficacy and performance of the OxySoft device by measuring pulse rate accuracy in a diverse subject population during motion and non-motion conditions and over a specified saturation range.
The acceptance criteria for pulse rate during motion conditions, on the motion hand, across the saturation range of 70-100% when paired with the N-600x:
PR OxySoft Sensor/N-600x ≤ 5 BPM
Measured: October 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start18 Aug 2020
- Primary completion21 Aug 2020
- Study completion21 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur Cabrera, MD, Principal investigator, Clinimark, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559763
- Sponsor's protocol ID
- MDT20006OXYVMT
- Status last verified
- Oct 2020
- First submitted
- 14 Aug 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All participant data will be analyzed and outlined in final study report. Individual participant data will only be made available to the participant and or participant primary care physician as applicable.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpO2 Accuracy Validation of the OxySoft Sensor Via Reference CO-Oximetry, During Motion and Non-Motion Conditions in Healthy, Well-Perfused Subjects
- ClinicalTrials.gov ID
- NCT04559763
- Acronym / sponsor ID
- MDT20006OXYVMT
- Conditions
- Hypoxia, Desaturation of Blood
- Keywords
- Oxygen Saturation, Invasive Controlled Desaturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 21 Aug 2020 (actual)
- First posted
- 23 Sep 2020 (actual)
- 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.
SpO2 (oxygen saturation) and pulse rate accuracy of pulse oximetry equipment, OxySoft Sensor/N-600x and OxySoft Sensor/N-395, continuous measure of arterial oxygen saturation during hypoxic state throughout motion and non-motion conditions under one system configuration.
The purpose of this Non-Randomized, Prospective,Observational study is to conduct a hypoxia study to directly compare a prototype OxySoft pulse oximeter system to arterial oxygen saturation.
Detailed description
The study utilizes a single-site, physiology laboratory for non-randomized, prospective, interventional studies. The goal is to enroll a range of twelve (12) to sixteen (16) healthy adult volunteers. Subjects may be of any race,ranging in pigmentation from light to dark to meet the study design requirements.
The general purpose of Invasive Controlled Desaturation Studies during motion is to validate the SpO2and pulse rate accuracy in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter during motion conditions. This is achieved through paired observations of SpO2 and SaO2values over the specified SpO2 accuracy range of 70 % to 100 % SaO2 of the prototype pulse oximeter on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted steady-state saturation periods. Arterial blood samples are periodically taken from an indwelling arterial catheter for use in the comparison.
Pulse rate accuracy will be evaluated during the same data collection period as SpO2. Pulse rate will be compared to reference ECG heart rate.In the unlikely event that the ECG monitor malfunctions, the Pulse rate reference may be taken using the average pulse rate value from the transfer standard pulse oximeters. This study is designed to support an FDA submission for pulse rate and saturation accuracy in a diverse subject population during motion conditions over a specified saturation range for the Oxysoft pulse oximetry system.
The FDA Guidance Document for Pulse Oximeters and ISO 80601-2-61 define the accepted guideline for evaluation and documenting the SpO2 accuracy in humans. The OxySoft sensor is not FDA approved for the intended study population, healthy adults. To support the development of Nellcor pulse oximeter systems, data is required to test the performance of the sensors with pulse oximetry systems in the adult patient population. In order to accurately validate sensors, manipulation of oxygen and nitrogen levels through the administration of oxygen and nitrogen gas will occur. Measurements of SpO2and pulse rate accuracy in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter during motion and non-motion conditions will be taken and analyzed to support development of Nellcor technology and support FDA submission.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adult Volunteers | – | Device: Non-Invasive Controlled Hypoxia, Other: Introduction of Motion conditions: tapping or rubbing |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will be a minimum of twelve subjects, ranging in pigmentation from light to dark to skin tones including subjects with deep pigmentation and the subject selection will be an equitable distribution of males and females.
Key inclusion criteria (8 listed)
- Subject must have the ability to understand and provide written informed consent
- Adult subjects 18 to 50 years of age.
- Subject must be willing and able to comply with study procedures and duration.
- Subject is a non-smoker or who has not smoked within 2 days prior to the study.
- Male or female of any race.
Key exclusion criteria (51 listed)
- Subject is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the sites utilized.)
- Females of childbearing potential, who are pregnant, who are trying to get pregnant or who have a urine test positive for pregnancy on the day of the study
- Subjects with COHb levels >3% as assessed by CO-Oximetry during the procedure
- tHb < 10 g/dl as assessed by CO-Oximetry during the procedure
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 |
|---|---|---|
| Non-Invasive Controlled HypoxiaAlso: Desaturation, Blood SamplingFollowing arterial cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject breathes while simultaneous measurements are recorded from the test pulse oximeters and arterial blood samples are collected at targeted levels of saturation. | Device | Healthy Adult Volunteers |
| Introduction of Motion conditions: tapping or rubbingStandard motions include tapping or rubbing at periodic intervals with amplitudes of 1-2 cm and 1-4 Hz with a random variation in frequency will occur at each plateau. Each plateau will have both an interval of tapping and rubbing. Signals are recorded by a validated, computerized data acquisition system (CAS). The device values are sampled once per second and averaged over the time taken to draw the blood sample, taking into account circulation time delays and differences in device response times | Other | Healthy Adult Volunteers |
Primary outcome
To investigate performance of the OxySoft device by measuring oxygen saturation accuracy during motion and non-motion conditions
Time frame: October 2020
The primary objective of the study is to investigate the efficacy and performance of the OxySoft device by measuring oxygen saturation accuracy in a diverse subject population during motion and non-motion conditions and over a specified saturation range. The acceptance criteria for SpO2, on the non-motion hand, across the saturation range of 70-100% when paired with the N-395: SpO2 OxySoft Sensor/N-395 ± 3% (Arms) The acceptance criteria for SpO2 during motion conditions, on the motion hand, across the saturation range of 70-100% when paired with the N-600x: SpO2 OxySoft Sensor/N-600x ± 3% (Arms)
To investigate efficacy and performance of OxySoft device by measuring pulse rate accuracy during motion and non-motion conditions
Time frame: October 2020
The secondary objective of the study is to investigate the efficacy and performance of the OxySoft device by measuring pulse rate accuracy in a diverse subject population during motion and non-motion conditions and over a specified saturation range. The acceptance criteria for pulse rate during motion conditions, on the motion hand, across the saturation range of 70-100% when paired with the N-600x: PR OxySoft Sensor/N-600x ≤ 5 BPM
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 22 Oct 2020.
- Individual participant dataSharing planned: No. All participant data will be analyzed and outlined in final study report. Individual participant data will only be made available to the participant and or participant primary care physician as applicable.
Related trials for Hypoxia
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
RecruitingObservational study
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Sleep Apnea, Obstructive Sleep Apnea
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Recruiting
Methodological Study of Exercise and Hypoxic Conditions in Healthy Subjects
Healthy Subjects (HS), Exercise
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.
Arthur Cabrera, MD principal investigator
Clinimark, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia and Desaturation of Blood, 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 8 inclusion and 51 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 22 Oct 2020. 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?
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?
To investigate performance of the OxySoft device by measuring oxygen saturation accuracy during motion and non-motion conditions (time frame: October 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2020.