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N/A N=20 Diagnostic

Vital USA Respiratory Rate Validation In Adults

Respiratory Complication

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Respiratory Rate Accuracy Validation for the Vital USA Vital Detect Monitor. — 1.39 Breaths/Min

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
The Vital Detect Pulse Oximeter (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Vital USA, Inc.
Primary completion
Dec 2019

Outcome Measures

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

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.

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.

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