Accuracy Assessment of Beddr Oximeter

NCT03710993 | Completed FDA Device

• 1 other identifier: PR 2018-290
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Accuracy performance of Beddr oximeter

Conditions

Oximetry

Outcome Measures

Primary Outcomes (1)

• SpO2 accuracy

  Collect and analyze data to assess SpO2 calibration and accuracy

  60 minutes

Interventions

oximeter DEVICE

Participants breathe a controlled gas mixture to induce several reduced oxygen states while oximeter measurements are taken for comparison to corresponding transfer standard and reference devices to assess oximeter calibration and accuracy.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy adult volunteers, ranging in pigmentation from light to dark.

You may qualify if:

• Subject must have the ability to understand and provide written informed consent
• Adult subjects 18 up to 50 years of age
• Subject must be willing and able to comply with study procedures and duration
• Subject is a non-smoker or who has not smoked within 2 days prior to the study.
• Male or female of any race
• Subject demographics include a range of skin pigmentations, including at least 1 darkly pigmented subjects or 15% of the subject pool, whichever is larger.

You may not qualify if:

• 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.)
• Females 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 known respiratory conditions such as:
• uncontrolled / severe asthma,
• flu,
• pneumonia / bronchitis,
• shortness of breath / respiratory distress,
• unresolved respiratory or lung surgery with continued indications of health issues,
• emphysema, COPD, lung disease
• Subjects with known heart or cardiovascular conditions such as:
• Hypertension: systolic \>140mmHg, Diastolic \>90mmHg on 3 consecutive readings.
• have had cardiovascular surgery
• Chest pain (angina)
• heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia

Sponsors & Collaborators

• Hancock Medical, Inc.: lead

Study Sites (1)

Clinimark

Louisville, Colorado, 80027, United States

Location

Study Officials

• Arthur Cabrera, MD

  Clinimark, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 18, 2018
• Study Start: July 30, 2018
• Primary Completion: August 3, 2018
• Study Completion: August 3, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)