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N/A Completed N=20 Diagnostic

Vital USA Respiratory Rate Validation In Adults

Respiratory Complication
Source: ClinicalTrials.gov NCT04292639 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Respiratory Rate Accuracy Validation for the Vital USA Vital Detect Monitor. — 1.39 Breaths/Min

Summary

Vital USA is dedicated to developing and applying innovative electronic medical solutions that improve patient care in multiple clinical settings. Vital USA is a manufacturer of a multi-parameter patient monitor that is intended to be used in a variety of medical settings including hospitals, medical offices and patients' homes.

Outcome Measures

OutcomeResultp-value
PRIMARY
Respiratory Rate Accuracy Validation for the Vital USA Vital Detect Monitor.
1.39

Eligibility Criteria

Inclusion Criteria

  • Subject must have the ability to understand and provide written informed consent
  • Subject is adult over 18 years of age
  • Subject must be willing and able to comply with study procedures and duration
  • Subject is a non-smoker
  • Male or female of any race

Exclusion Criteria

Subject is considered as being morbidly obese (defined as BMI >39.5)

  • Compromised circulation, injury, or physical malformation of fingers, toes, 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 particular sites utilized.)
  • Subjects with known respiratory conditions such as:
  • uncontrolled / severe asthma,
  • flu,
  • pneumonia / bronchitis,
  • shortness of breath / respiratory distress,
  • respiratory or lung surgery,
  • emphysema, COPD, lung disease
  • Subjects with self-reported heart or cardiovascular conditions such as:
  • have had cardiovascular surgery
  • Chest pain (angina)
  • heart rhythms other than a normal sinus rhythm or with 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 head injury within the last 2 months,
  • Cancer / chemotherapy
  • Other known health condition, should be considered upon disclosure in health assessment form
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04292639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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