Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT03593603
Eligibility Criteria:
Inclusion Criteria:
1. 18 years or older.
2. A patient who meets the weight requirement for the sensor (e.g. \>30kg).
3. A patient at the study site on a General Care Floor (surgical or medical/non-surgical to be distributed equally) and prescribed standard vital sign checks.
4. Patient is willing and able to provide written informed consent.
Exclusion Criteria:
1. Expected length of stay is \< 4 hours.
2. Patient is pregnant or lactating.
3. Patient has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors.
4. Patient has an abnormality that may prevent proper application of the device.
5. Patient is in atrial fibrillation.
6. Patient has a documented history of frequent premature atrial contractions (PACs) or premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds within the past 3 months.
7. Patient has an implanted pacemaker.
8. Patient has excessive nail polish that cannot be removed or other dye or discoloration of the finger.
9. Patient has diagnosed central apnea or diagnosed significant obstructive sleep apnea.
10. Patient is currently using continuous positive airway pressure (CPAP).
11. Patient is unwilling or unable to sign informed consent.
12. Evidence that the patient cannot understand the purpose and risks of the study and would require a legally authorized representative to sign informed consent.
13. Patient is participating in another potentially confounding clinical study.
14. Extreme motion conditions such as patient is prescribed to walk more than once per hour or is prescribed a medical device resulting in constant movement.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03593603
Study Brief:
Protocol Section:
NCT03593603