Clinical Trials Logo
  1. Home
  2. Hypoxia
  3. NCT00881829
  4. Details
NCT00881829 Clinical Trial

Hypoxia Blood Validation in Multiple Pulse Oximeters

Hypoxia Clinical Trial

Official title:
Accuracy Validation in Multiple SpO2 Systems

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00881829
Other study ID # PR 2016-192 Rev 1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 9, 2016
Est. completion date December 21, 2021

Study information
Verified date February 2021
Source Clinimark, LLC
Contact Dena M Raley, BSBE
Phone 303-249-6010
Email DMRaley@Clinimark.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the SpO2 accuracy and performance of multiple pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. This study is observational in nature which quantifies device performance and accuracy in comparison to a Reference Standard.

Description:

The purpose of this study is to evaluate the SpO2 accuracy and performance of pulse oximeters 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 pulse oximeters. It is expected that the Accuracy Root Mean Square (Arms) performance of pulse oximeters 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

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 21, 2021
Est. primary completion date December 21, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - healthy individuals between the age of 18-50 years. Exclusion Criteria: - Clotting disorders, diabetes, currently taking psychotropic medications.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature
Measurement of physiological parameters.

Locations
Country Name City State
United States Clinimark Laboratories Louisville Colorado

Sponsors (1)
Lead Sponsor Collaborator
Clinimark, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Completion of study by all subjects 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT04498598 - Structural Modification In Supraglottic Airway Device N/A
Completed NCT05532670 - N600X Low Saturation Accuracy Validation
Enrolling by invitation NCT04106401 - Intravascular Volumes in Hypoxia During Antarctic Confinement N/A
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Not yet recruiting NCT05817448 - Hypoxia-induced Autophagy in the Pathogenesis of MAP
Recruiting NCT02661152 - DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC. Phase 3
Terminated NCT02801162 - Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard N/A
Not yet recruiting NCT02201875 - Intrinsic Periodic Pattern of Breathing N/A
Completed NCT02943863 - Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia N/A
Completed NCT02105298 - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study) N/A
Completed NCT01922401 - Inverse Ratio Ventilation on Bariatric Operation N/A
Active, not recruiting NCT01681238 - Goal-directed Therapy in High-risk Surgery N/A
Completed NCT01463527 - Using Capnography to Reduce Hypoxia During Pediatric Sedation N/A
Completed NCT01507623 - Value of Capnography During Nurse Administered Propofol Sedation (NAPS) N/A
Withdrawn NCT00638040 - The Gene Expression Studies of the Role of Tumor Microenvironments in Tumor Progression N/A
Active, not recruiting NCT06097754 - Intermittent Exogenous Ketosis (IEK) at High Altitude N/A
Completed NCT04589923 - The VISION-Acute Study
Completed NCT05044585 - Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers N/A
Completed NCT03659513 - The Effect of ECMO on the Pharmacokinetics of the Drugs and Their Clinical Efficacy
Completed NCT03221387 - Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients N/A