COMPLETED

OM2 Low Saturation Verification

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations.

Official Title

Low Saturation Verification of Investigational Pulse Oximetry Devices in Adult Volunteers

Quick Facts

Study Start:2024-11-18

Study Completion:2025-05-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06661889

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 39 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Healthy volunteers 18 to ≤39 years 2. Subject is willing and able to comply with study procedures and duration 3. Subject is willing to sign an informed consent 4. Subject weighs \>40kg 5. Subject is a non-smoker or has not smoked within 2 days prior to the study 6. Cleared same day health assessment form and health screening	1. Subject is considered as being morbidly obese (defined as BMI \>39.5) 2. 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) 3. Subjects 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 4. Subjects with known concurrent, active respiratory conditions such as: 1. uncontrolled / severe asthma 2. flu or influenza type infection 3. pneumonia / bronchitis 4. shortness of breath / respiratory distress 5. unresolved respiratory or lung surgery 6. emphysema, COPD, lung disease 7. recent COVID (last 2 months) 5. Subjects with known heart or cardiovascular conditions such as: 1. hypertension: systolic \>140mmHg, or Diastolic \>90mmHg on 3 consecutive readings 2. have had cardiovascular surgery 3. chest pain (angina) 4. heart rhythms other than a normal sinus rhythm and/or with respiratory sinus arrhythmia, at the discretion of the Principal Investigator or designee 5. previous heart attack 6. blocked artery 7. unexplained shortness of breath 8. congestive heart failure (CHF) 9. history of stroke 10. transient ischemic attack 11. carotid artery disease 12. myocardial ischemia 13. myocardial infarction 14. cardiomyopathy 15. implantable active medical device such as pacemaker or automatic defibrillator 6. Self-reported health conditions as identified in the Health Assessment Form 1. diabetes 2. uncontrolled thyroid disease 3. kidney disease / chronic renal impairment 4. history of seizures (except childhood febrile seizures) 5. epilepsy 6. history of unexplained syncope 7. recent history of frequent migraine headaches 8. recent symptomatic head injury, within the last 2 months 9. cancer requiring chemotherapy, radiation, or current treatment 10. subjects with known clotting disorders 11. history of bleeding disorders or personal history of prolonged bleeding from injury 12. history of blood clots 13. hemophilia 14. sickle cell trait or disease 15. current use of blood thinner: prescription or daily use such as aspirin 16. 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 17. participants with severe allergy to iodine (only applicable if iodine is used) 18. subjects with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin 19. arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right) 20. history of clinically significant complications from previous arterial cannulation 21. unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits 22. other known health condition, upon disclosure in Health Assessment form

Inclusion Criteria

Exclusion Criteria

1. Healthy volunteers 18 to ≤39 years
2. Subject is willing and able to comply with study procedures and duration
3. Subject is willing to sign an informed consent
4. Subject weighs \>40kg
5. Subject is a non-smoker or has not smoked within 2 days prior to the study
6. Cleared same day health assessment form and health screening

1. Subject is considered as being morbidly obese (defined as BMI \>39.5)
2. 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)
3. Subjects 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
4. Subjects with known concurrent, active respiratory conditions such as:
1. uncontrolled / severe asthma
2. flu or influenza type infection
3. pneumonia / bronchitis
4. shortness of breath / respiratory distress
5. unresolved respiratory or lung surgery
6. emphysema, COPD, lung disease
7. recent COVID (last 2 months)
5. Subjects with known heart or cardiovascular conditions such as:
1. hypertension: systolic \>140mmHg, or Diastolic \>90mmHg on 3 consecutive readings
2. have had cardiovascular surgery
3. chest pain (angina)
4. heart rhythms other than a normal sinus rhythm and/or with respiratory sinus arrhythmia, at the discretion of the Principal Investigator or designee
5. previous heart attack
6. blocked artery
7. unexplained shortness of breath
8. congestive heart failure (CHF)
9. history of stroke
10. transient ischemic attack
11. carotid artery disease
12. myocardial ischemia
13. myocardial infarction
14. cardiomyopathy
15. implantable active medical device such as pacemaker or automatic defibrillator
6. Self-reported health conditions as identified in the Health Assessment Form
1. diabetes
2. uncontrolled thyroid disease
3. kidney disease / chronic renal impairment
4. history of seizures (except childhood febrile seizures)
5. epilepsy
6. history of unexplained syncope
7. recent history of frequent migraine headaches
8. recent symptomatic head injury, within the last 2 months
9. cancer requiring chemotherapy, radiation, or current treatment
10. subjects with known clotting disorders
11. history of bleeding disorders or personal history of prolonged bleeding from injury
12. history of blood clots
13. hemophilia
14. sickle cell trait or disease
15. current use of blood thinner: prescription or daily use such as aspirin
16. 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
17. participants with severe allergy to iodine (only applicable if iodine is used)
18. subjects with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin
19. arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right)
20. history of clinically significant complications from previous arterial cannulation
21. unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits
22. other known health condition, upon disclosure in Health Assessment form

Contacts and Locations

Principal Investigator

Randall M Clark

PRINCIPAL_INVESTIGATOR

Medtronic Clinical Physiology Laboratory

David Macleod

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Medtronic Clinical Physiology Lab

Denver, Colorado, 80218

United States

Collaborators and Investigators

Sponsor: Medtronic - MITG

Randall M Clark, PRINCIPAL_INVESTIGATOR, Medtronic Clinical Physiology Laboratory
David Macleod, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-18

Study Completion Date2025-05-27

Study Record Updates

Study Start Date2024-11-18

Study Completion Date2025-05-27

Terms related to this study

Keywords Provided by Researchers

Low Saturation
Pulse Oximetry

Additional Relevant MeSH Terms

Hypoxia