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Trial record 13 of 629 for:    oximeter

Accuracy of Pulse Oximeters With Profound Hypoxia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03710980
Recruitment Status : Completed
First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Hancock Medical, Inc.

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

Condition or disease Intervention/treatment
Oximetry Device: Oximeter

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Accuracy of Pulse Oximeters With Profound Hypoxia
Actual Study Start Date : September 18, 2018
Actual Primary Completion Date : September 19, 2018
Actual Study Completion Date : September 19, 2018

Group/Cohort Intervention/treatment
Healthy Adult Volunteer Device: Oximeter
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.




Primary Outcome Measures :
  1. SpO2 Accuracy [ Time Frame: 60 minutes ]
    Collect and analyze data to determine SpO2 accuracy of oximeters under test.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy adult volunteers.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. The subject is obese (BMI>30).
  2. The subject has a known history of heart disease, lung disease, kidney or liver disease.
  3. Diagnosis of asthma, sleep apnea, or use of CPAP.
  4. Subject has diabetes.
  5. Subject has a clotting disorder.
  6. 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.
  7. The subject has any other serious systemic illness.
  8. The subject is a current smoker.
  9. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
  10. The subject has a history of fainting or vasovagal response.
  11. The subject has a history of sensitivity to local anesthesia.
  12. The subject has a diagnosis of Raynaud's disease.
  13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
  14. The subject is pregnant, lactating or trying to get pregnant.
  15. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
  16. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03710980


Locations
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United States, California
UCSF Hypoxia Lab
San Francisco, California, United States, 94143
Sponsors and Collaborators
Hancock Medical, Inc.

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Responsible Party: Hancock Medical, Inc.
ClinicalTrials.gov Identifier: NCT03710980     History of Changes
Other Study ID Numbers: BEDD01
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms