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Accuracy of Pulse Oximeter With Profound Hypoxia

Primary Purpose

Hypoxia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ANNE Limb Sensor
Sponsored by
Sibel Health Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypoxia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: The subject is male or female, between the ages of 18 and 55 years. 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: 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 has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation The subject has any other serious systemic illness Th 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 The subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study

Sites / Locations

  • Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Comparison of ANNE Limb Sensor pulse oximetry measurements to blood gas analysis

Arm Description

Outcomes

Primary Outcome Measures

ARMS of SpO2 Measurements with ANNE Limb compared to SaO2
Root mean square error between the function blood oxygen saturation (SpO2) provided by the device under test and the blood gas analysis of oxyhemoglobin saturation (SaO2)

Secondary Outcome Measures

Full Information

First Posted
December 27, 2022
Last Updated
January 12, 2023
Sponsor
Sibel Health Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05693168
Brief Title
Accuracy of Pulse Oximeter With Profound Hypoxia
Official Title
Accuracy of Pulse Oximeter With Profound Hypoxia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
June 24, 2021 (Actual)
Study Completion Date
June 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sibel Health Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Clinical evaluation of the accuracy of SpO2 measurements with the ANNE Limb Sensor compared to blood gas analysis in healthy, adult subjects. Hypoxia is induced in patients to different and stable levels of SaO2 over the range of 70-100%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia

7. Study Design

Primary Purpose
Diagnostic
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
Comparison of ANNE Limb Sensor pulse oximetry measurements to blood gas analysis
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ANNE Limb Sensor
Intervention Description
Pulse Oximeter
Primary Outcome Measure Information:
Title
ARMS of SpO2 Measurements with ANNE Limb compared to SaO2
Description
Root mean square error between the function blood oxygen saturation (SpO2) provided by the device under test and the blood gas analysis of oxyhemoglobin saturation (SaO2)
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The subject is male or female, between the ages of 18 and 55 years. 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: 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 has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation The subject has any other serious systemic illness Th 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 The subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study
Facility Information:
Facility Name
Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California, 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 Oximeter With Profound Hypoxia

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