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HypoxiaNCT05532670

N600X Low Saturation Accuracy Validation

An observational study of Hypoxia, 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.

Official record
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Trial summary

To compare pulse oximetry saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from healthy human subjects. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Hypoxia
Type of treatment
Medical device
How many people
15 participants
Where
1 siteUnited States
Study dates
29 Sep 2022to 1 Nov 2022
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: Study Population The study population includes a 15 healthy non-smoking competent adults 18-50 years of age. With an aim of diversity across ethnicity, race and sex of varying skin tones.

Who may be able to join

  • 1. Subject must have the ability to understand and provide written informed consent
  • 2 Adult subjects 18 to 50 years of age.
  • 3. Subject must be willing and able to comply with study procedures and duration.
  • 4. Subject is a non-smoker or who has not smoked within 2 days prior to the study.
  • 5. Any gender of any race.
  • 6. Cleared same day Health Assessment form and health screening.
  • 7. Cleared physical exam by a licensed physician, physician assistant, or advanced practice nurse (medical exam includes 12-lead ECG, medical history and blood test to show no sickle cell disease present)
  • 8. Successful Perfusion Index Ulnar/Ulnar+Radial Ratio test showing adequate collateral blood flow.

Who cannot join

  • Subject with sickle cell disease.
  • 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
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  • MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
  • Subjects with known respiratory conditions such as:
  • uncontrolled / severe asthma,
  • flu or influenza type infection
  • 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 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.

United States1 site

  • Clinimark

    Louisville, Colorado, 80027

Other trials in United States

About this study

Official title: SpO2 Accuracy Validation of N600x Sensors Via Reference CO-Oximetry in Healthy, Well-Perfused Subjects

To compare pulse oximetry saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from healthy human subjects.

Read the detailed description

The study utilizes a single-site, physiology laboratory (Clinimark) to conduct this Post Market, non-randomized, prospective studies. The goal is to enroll a minimum of fifteen subjects. Subject pool goal of diversity across ethnicity, race and sex of varying skin tones to meet the study design requirements.

The general purpose of Invasive Controlled Desaturation Studies is to support the SpO2 accuracy of the post market pulse oximetry sensors and paired monitor in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter during low saturation conditions. This is achieved through paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of 60% to 100% SaO2 of the 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.

Conditions
Hypoxia
Being tested
Non-Invasive Controlled Hypoxia
Keywords
Oxygen Saturation, Invasive Controlled Desaturation, Pulse Oximetry, Desaturation of Blood
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.

What is being measured

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

  1. Comparison of pulse rate (BPM) by a pulse oximeter monitor and sensor, compared to ECG pulse rate measurement

    To validate the proposed claims for pulse rate (BPM) accuracy in diverse subject population during Low Saturation over a specified saturation ranges.

    Measured: October 2022

  2. Comparison of SPO2 saturation levels by a pulse oximeter to saturation measurements made by a multi-wavelength CO-oximeter.

    To validate the proposed claims for SPO2 saturation accuracy in diverse subject population during Low Saturation over a specified saturation ranges.

    Measured: October 2022

Timeline

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

  1. First posted8 Sep 2022
  2. Study start29 Sep 2022
  3. Primary completion7 Oct 2022
  4. Study completion1 Nov 2022

Resources

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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05532670
Sponsor's protocol ID
MDT22013LSOXMN
Status last verified
Nov 2022
First submitted
31 Aug 2022
Last updated
23 Nov 2022
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypoxia, 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 50 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 23 Nov 2022. 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?

Comparison of pulse rate (BPM) by a pulse oximeter monitor and sensor, compared to ECG pulse rate measurement (time frame: October 2022). 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?

On the ClinicalTrials.gov record for NCT05532670.

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 23 Nov 2022.

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