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Pulse Oximetry Calibration for Hypoxia
N/A
Waitlist Available
Research Sponsored by Rhythm Diagnostic Systems
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is 18 to 50 years of age
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from device placement to device removal, assessed up to 3 hours
Awards & highlights
Study Summary
This trial will test a device to measure blood oxygen levels in healthy adults of all skin tones, from light to dark. Data from the device will be compared to a gold-standard reference, to meet FDA guidelines.
Who is the study for?
Healthy adults aged 18-50, non-smokers or those who haven't smoked in the last 2 days. Participants must have a range of skin tones, including at least three with dark pigmentation. They should be able to follow study procedures and give written consent. Excluded are morbidly obese individuals, pregnant women, people with certain health conditions like heart issues or severe allergies to sensor materials.Check my eligibility
What is being tested?
The trial is testing the MultiSense® pulse oximetry system's accuracy in measuring oxygen saturation (SpO2) during non-motion conditions against a reference system. It involves subjects with varying skin pigmentations and uses induced hypoxic levels to evaluate performance.See study design
What are the potential side effects?
There may not be direct side effects from participating as this is a device calibration study; however, discomfort from wearing the device on the thorax or potential skin irritation from adhesives used for attaching sensors could occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from device placement to device removal, assessed up to 3 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from device placement to device removal, assessed up to 3 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determination of the quality of measurements of arterial blood saturation (SpO2) provided by the MultiSense® system in comparison to measurements made with a reference Pulse Oximetry System, in terms of accuracy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Controled Hypoxia - Healthy volunteerExperimental Treatment1 Intervention
Male and female subjects, ranging in pigmentation from light to dark
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Who is running the clinical trial?
Rhythm Diagnostic SystemsLead Sponsor
5 Previous Clinical Trials
171 Total Patients Enrolled
2 Trials studying Hypoxia
28 Patients Enrolled for Hypoxia
Clinimark, LLCOTHER
21 Previous Clinical Trials
973 Total Patients Enrolled
8 Trials studying Hypoxia
577 Patients Enrolled for Hypoxia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The study needs to include people with different skin colors, including at least 3 people with dark skin or 15% of the total participants, whichever is more.I am a person of any gender or race.You have health conditions that you have reported on the health assessment form.I do not want to have my chest or any area shaved for tests.I have a known respiratory condition.I have a heart condition or a device like a pacemaker.My BMI is over 39.5, indicating morbid obesity.You have physical conditions or injuries on your fingers, toes, hands, ears, or forehead/skull that could affect the study tests.I am unable or unwilling to remove nail polish for tests.You have smoked in the past 2 days and have high levels of carbon monoxide in your blood.I am not pregnant nor trying to become pregnant.I am between 18 and 50 years old.You have other health conditions that should be discussed in the health assessment form.I have not smoked in the last 2 days.You have severe allergies to common medical adhesives, latex, or other materials found in medical sensors.
Research Study Groups:
This trial has the following groups:- Group 1: Controled Hypoxia - Healthy volunteer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the current research encompass participants aged over twenty?
"Those hoping to enroll in this clinical trial must meet the criteria of being between 18 and 50 years old. There are alternative trials offered for those younger than eighteen, as well as 86 trials available specifically for seniors over 65."
Answered by AI
Who can be accepted into this trial as a participant?
"To qualify for this clinical trial, applicants should have hypoxia and lie between the ages 18-50. The total participant count is limited to 16 individuals."
Answered by AI
Are individuals being recruited for this clinical experiment at present?
"The data hosted on clinicaltrials.gov indicates that this medical trial is no longer actively seeking participants, with the initial posting being made in March 15th 2022 and its last edit occurring a year later. However, 142 other studies are currently recruiting patients to participate.."
Answered by AI
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