Status:
ACTIVE_NOT_RECRUITING
Nellcor™ Abbreviated Sensor Additional Data Collection
Lead Sponsor:
Medtronic - MITG
Conditions:
Oxygen Saturation Measurement
Eligibility:
All Genders
18-51 years
Brief Summary
To collect data on a variety of market approved Nellcor™ pulse oximetry sensors with the Nellcor™ Pulse Oximetry device to support the market approval.
Detailed Description
The purpose of this study is to collect data on the Nellcor™ Pulse Oximetry device when paired with a variety of Nellcor™ Market Released sensors under invasive, controlled desaturation conditions, to...
Eligibility Criteria
Inclusion
- Male or female participants ≥ 18 years of age, and \< 51 years of age.
- Participant is willing and able to comply with study procedures and duration.
- Participant is willing to sign an ICF.
- Participant weighs \> 40kg (88.2 lb).
- Participant is a non-smoker or has not smoked within 36 hours prior to the study.
- Cleared same day health assessment form and health screening
- Successful perfusion index ulnar/ulnar+radial ratio test (Assessed via the Allen's Test) showing adequate collateral blood flow.
Exclusion
- Participant 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 participants to participate if the condition is noted and would not affect the sites utilized)
- Participants 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
- MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
- Participants 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
- recent COVID (last 2 months)
- Participants with known heart or cardiovascular conditions such as:
- Uncontrolled hypertension (systolic pressure \>140mmHg, or diastolic pressure \>90mmHg on 3 consecutive readings day of screening)
- previous cardiovascular surgery
- chest pain (angina)
- heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
- previous heart attack
- blocked artery
- unexplained shortness of breath
- congestive heart failure (CHF)
- history of stroke and/or transient ischemic attack
- carotid artery disease
- myocardial ischemia
- myocardial infarction
- cardiomyopathy
- implantable active medical device such as pacemaker or automatic defibrillator
- 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 (within the last 2 months)
- recent symptomatic head injury (within the last 2 months)
- cancer requiring chemotherapy, radiation, or current treatment
- participants with known clotting disorders
- history of bleeding disorders or personal history of prolonged bleeding from injury
- history of blood clots
- hemophilia
- sickle cell trait or disease
- current use of blood thinner: prescription or daily use of aspirin
- participants 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
- participants with severe allergy to iodine (only applicable if iodine is used)
- participants 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
- unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits
- other known health condition, upon disclosure in Health Assessment form
- Failure of the Allen's Test.
Key Trial Info
Start Date :
July 24 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT07201961
Start Date
July 24 2025
End Date
January 1 2026
Last Update
October 1 2025
Active Locations (1)
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1
Medtronic Clinical Physiology Lab
Denver, Colorado, United States, 80218