Back to resultsAccuracy of Pulse Oximeters With Profound Hypoxia
Primary Purpose
SpO2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A-line
Sponsored by
About this trial
This is an interventional other trial for SpO2
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- University of California at San Francisco
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single
Arm Description
Subjects undergo an interventional procedure and non-invasive measurements of SpO2.
Outcomes
Primary Outcome Measures
Accuracy of pulse oximeter with profound hypoxia
Perform accurate measurement of a range of arterial HbO2 saturation from 100 to down to 70% during mild, moderate, and severe hypoxia.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05322382
Brief Title
Accuracy of Pulse Oximeters With Profound Hypoxia
Official Title
Accuracy of Pulse Oximeters With Profound Hypoxia - Test Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
June 3, 2021 (Actual)
Study Completion Date
June 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CardiacSense Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project aims to test the accuracy of pulse oximeters during mild, moderate, and severe hypoxia, i.e., a range of arterial HbO2 saturation from 100 down to 70%. A typical study will include at least ten subjects (at least 200 necessary data points to meet the ISO 80601-2-61:2017).
Detailed Description
After local anesthetic injection, a 22-gauge catheter is inserted in one radial artery. Pulse oximeters are attached to fingers, ears, or flat body surfaces. Subjects are in a comfortable semi-recumbent position. Subjects then breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia. Stable, safe, and controlled hypoxia is breath-by-breath by breath respiratory gas analysis and a computer program that permits the inspired gas mixture to be adjusted to achieve a level of lung alveolar gas that will achieve the desired degree of saturation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SpO2
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single
Arm Type
Experimental
Arm Description
Subjects undergo an interventional procedure and non-invasive measurements of SpO2.
Intervention Type
Procedure
Intervention Name(s)
A-line
Other Intervention Name(s)
Hypoxemia
Intervention Description
Subjects breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia.
Primary Outcome Measure Information:
Title
Accuracy of pulse oximeter with profound hypoxia
Description
Perform accurate measurement of a range of arterial HbO2 saturation from 100 to down to 70% during mild, moderate, and severe hypoxia.
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Bickler, MD
Organizational Affiliation
UCSF Hypoxia Lab
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Accuracy of Pulse Oximeters With Profound Hypoxia
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