Accuracy Validation of the Cadwell Pulse Oximetry System

NCT02842476 | Completed

• 1 other identifier: PR 2016-177
• Study Type: observational
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the SpO2 accuracy and performance of the Cadwell Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the Cadwell Pulse Oximetry System. It is expected that the Accuracy Root Mean Square (Arms) performance of the Cadwell Pulse Oximetry System will meet a specification of 3 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.

Conditions

Anoxia

Keywords

pulse oximetry

Outcome Measures

Primary Outcomes (1)

• SpO2 Sensor Values

  SpO2 values (%) from the Cadwell pulse oximetry device using disposable and reusable sensors were collected electronically at one second intervals.

  Through study completion, an average of 1 day

Secondary Outcomes (1)

• Arterial Oxygen Saturation

  Through study completion, an average of 1 day

Study Arms (3)

Disposable Sensor

Adhesive based Pulse Oximeter Probes, Model S0136J

Device: Disposable Sensor

Reusable Sensor

Reusable Pulse Oximeter Probes, Model S0080D

Device: Reusable Sensor

Control Pulse Oximetry

Reference CO-Oximeters ABL80 Flex OSM (Radiometer), # 302125, 307205 IL682 (Instrumentation Laboratories), # 012511B (ILH), #012511A (ILG)

Device: Control Pulse Oximetry

Interventions

Disposable Sensor DEVICE

Two adhesive based Pulse Oximeter Probes, S0136J-L were connected to the Cadwell Pulse Oximetry and then placed on each subject to evaluate the SpO2 accuracy performance during steady state non-motion conditions.

Also known as: Model S0136J-L

Disposable Sensor

Reusable Sensor DEVICE

Two soft reusable Pulse Oximeter Probes, Model S0080D-S were connected to the Cadwell Pulse Oximetry and then placed on each subject to evaluate the SpO2 accuracy performance during steady state non-motion conditions.

Also known as: Model S0080D-S

Reusable Sensor

Control Pulse Oximetry DEVICE

A Clinimark Control Pulse Oximetry system was also placed on the subject to evaluate the stability of the draws.

Also known as: Reference Co-Oximeters, ABL80 Flex OSM (Radiometer): # 302125, 307205 IL682 (Instrumentation Laboratories): # 012511B (ILH), #012511A (ILG)

Control Pulse Oximetry

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Following Salus Independent Review Board (IRB) approval for the Study Procedure Title: "Accuracy Validation of the Cadwell Pulse Oximetry System", Clinimark Study ID# PR 2016-177, eleven healthy adult volunteer subjects were enrolled into the study. The demographics for the study included five males and six females (age: 21-46yrs, weight: 118-220lbs, height: 60-74", BMI: 20.9-30.7). For the demographics based on race, the subject pool included one Black / African-American, three Asians (one of Indian descent), and seven White. The ethnicity for the group is four Hispanic, and seven Non-Hispanic / Non-Latino. The skin pigmentation / tones ranged from light to dark meeting the requirement of at least 2 darkly pigmented or 15 % of the subject pool whichever is larger.

You may qualify if:

• Ability to understand and provide written informed consent
• to 50 years of age
• Non-smoker or who has not smoked within 2 days prior to the study.
• Male or female
• Any race

You may not qualify if:

• Morbidly obese (defined as BMI \>39.5)
• Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull
• Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
• COHb levels \>3% as assessed with a Masimo Radical 7 (Rainbow)
• Respiratory conditions
• Heart or cardiovascular conditions
• Self reported health conditions
• Blood clotting disorders
• Severe contact allergies to standard adhesives, latex or other materials
• Unwillingness or inability to remove colored nail polish from test digits
• Other known health condition, should be considered upon disclosure in health

Sponsors & Collaborators

• Cadwell Industries, Inc.: lead
• Clinimark, LLC: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed by Reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison.

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 25, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 25, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share