Accuracy of Pulse Oximeters With Profound Hypoxia

NCT03710980 | Completed FDA Device

• 1 other identifier: BEDD01
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study to assess the oxygen saturation accuracy of the Beddr SleepTuner in profound hypoxia.

Conditions

Oximetry

Outcome Measures

Primary Outcomes (1)

• SpO2 Accuracy

  Collect and analyze data to determine SpO2 accuracy of oximeters under test.

  60 minutes

Study Arms (1)

Healthy Adult Volunteer

Device: Oximeter

Interventions

Oximeter DEVICE

Participants breathe a controlled gas mixture to induce several reduced oxygen states while oximeter measurements are taken for comparison to corresponding arterial blood draw samples to assess oximeter accuracy.

Healthy Adult Volunteer

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.

You may qualify if:

• The subject is male or female, aged ≥18 and \<50.
• The subject is in good general health with no evidence of any medical problems.
• The subject is fluent in both written and spoken English.
• The subject has provided informed consent and is willing to comply with the study procedures.

You may not qualify if:

• The subject is obese (BMI\>30).
• The subject has a known history of heart disease, lung disease, kidney or liver disease.
• Diagnosis of asthma, sleep apnea, or use of CPAP.
• Subject has diabetes.
• Subject has a clotting disorder.
• The subject a hemoglobinopathy or history of anemia, per subject report or the first bloodsample, that in the opinion of the investigator, would make them unsuitable for study participation.
• The subject has any other serious systemic illness.
• The subject is a current smoker.
• Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
• The subject has a history of fainting or vasovagal response.
• The subject has a history of sensitivity to local anesthesia.
• The subject has a diagnosis of Raynaud's disease.
• The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
• The subject is pregnant, lactating or trying to get pregnant.
• The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.

Sponsors & Collaborators

• Hancock Medical, Inc.: lead

Study Sites (1)

UCSF Hypoxia Lab

San Francisco, California, 94143, United States

Location

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: September 18, 2018
• Primary Completion: September 19, 2018
• Study Completion: September 19, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

US (1)