Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry

NCT04285411 | Completed Results DMC FDA Device

• 1 other identifier: PR 2019-353
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Investigation Plan: Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry Study ID# PR 2019-353, Version: Rev 1, Date: 15 Oct 2019 Study Dates: November 4-5, 2019

Conditions

Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Evaluate SpO2 Accuracy Per Standards for Pulse Oximetry.

  This study was a comparative, single-center, non-randomized study conducted to evaluate the SpO2 accuracy per standards and guidelines identified above for SpO2 accuracy for pulse oximetry equipment over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison. As a secondary goal, the pulse rate accuracy was compared to ECG Heart Rate realized over the range throughout the hypoxia procedure. Testing was conducted under normal office environment conditions.

  90 Seconds

Secondary Outcomes (1)

• The Pulse Rate Accuracy Compared to ECG Heart Rate.

  90 Seconds

Study Arms (1)

ARMS SpO2 70-100%

EXPERIMENTAL

Comparison to Reference CO-Oximetry

Device: Accuracy of the VitalDetect™ pulse oximetry system

Interventions

Accuracy of the VitalDetect™ pulse oximetry system DEVICE

The purpose of this study was to validate the SpO2 accuracy of the VitalDetect™ pulse oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less.

ARMS SpO2 70-100%

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults with a minimum of 3 males and a minimum of 3 females, with the balance made up of either
• Subject must have the ability to understand and provide written informed consent
• Subject is 18 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

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, wrist, 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.)
• Female subjects that are actively trying to get pregnant or are pregnant (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential).
• Smoker Subjects who have refrained will be screened for COPD levels \>3% as assessed with a Radical 7 (Rainbow)
• Subjects with known respiratory conditions such as: (self-reported):
• 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: (self-reported, except for blood pressure and ECG review)
• hypertension: systolic \>140mmHg, Diastolic \>90mmHg on 3 consecutive readings (reviewed during health screen).
• have had cardiovascular surgery
• Chest pain (angina)

Sponsors & Collaborators

• Vital USA, Inc.: lead
• Clinimark, LLC: collaborator

Study Sites (1)

Clinimark Laboratory Services

Louisville, Colorado, 80027, United States

Location

Results Point of Contact

• Title: Mark H Khachaturian, PhD
• Organization: Vital USA Inc.

mark.khachaturian@vvvital.com

+1(561)282-6074

Study Officials

• Arthur Ruiz, MD

  Avista Adventist Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Testing was conducted under normal office environment conditions. The VitalDetect™ pulse oximetry was placed on the right index finger of all subjects to evaluate the SpO2 and pulse rate accuracy performance during steady state non-motion conditions. A Control Pulse Oximetry system was also placed on the subject to evaluate the stability of the draws and the real time oxygen saturation status. The subject was in a reclined position and connected to a breathing circuit, for administering medical grade oxygen and nitrogen. The gas flow delivery was adjusted for subject comfort. Arterial blood samples were drawn during simultaneous data collection from the control pulse oximeter and the test oximeters. The blood was immediately analyzed by Reference CO-Oximetry providing functional SpO2 for the basis of the SpO2 accuracy comparison. The pulse rate for the VitalDetect™ was compared to Reference ECG Heart Rate collected during the study.

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: February 26, 2020
• Study Start: November 4, 2019
• Primary Completion: November 5, 2019
• Study Completion: November 20, 2019
• Last Updated: June 2, 2020
• Results First Posted: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)