Clinical Trials Logo

Clinical Trial Summary

SpO2 (oxygen saturation) and pulse rate accuracy of pulse oximetry equipment, OxySoft Sensor/N-600x and OxySoft Sensor/N-395, continuous measure of arterial oxygen saturation during hypoxic state throughout motion and non-motion conditions under one system configuration. The purpose of this Non-Randomized, Prospective,Observational study is to conduct a hypoxia study to directly compare a prototype OxySoft pulse oximeter system to arterial oxygen saturation.


Clinical Trial Description

The study utilizes a single-site, physiology laboratory for non-randomized, prospective, interventional studies. The goal is to enroll a range of twelve (12) to sixteen (16) healthy adult volunteers. Subjects may be of any race,ranging in pigmentation from light to dark to meet the study design requirements. The general purpose of Invasive Controlled Desaturation Studies during motion is to validate the SpO2and pulse rate accuracy in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter during motion conditions. This is achieved through paired observations of SpO2 and SaO2values over the specified SpO2 accuracy range of 70 % to 100 % SaO2 of the prototype pulse oximeter on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted steady-state saturation periods. Arterial blood samples are periodically taken from an indwelling arterial catheter for use in the comparison. Pulse rate accuracy will be evaluated during the same data collection period as SpO2. Pulse rate will be compared to reference ECG heart rate.In the unlikely event that the ECG monitor malfunctions, the Pulse rate reference may be taken using the average pulse rate value from the transfer standard pulse oximeters. This study is designed to support an FDA submission for pulse rate and saturation accuracy in a diverse subject population during motion conditions over a specified saturation range for the Oxysoft pulse oximetry system. The FDA Guidance Document for Pulse Oximeters and ISO 80601-2-61 define the accepted guideline for evaluation and documenting the SpO2 accuracy in humans. The OxySoft sensor is not FDA approved for the intended study population, healthy adults. To support the development of Nellcor pulse oximeter systems, data is required to test the performance of the sensors with pulse oximetry systems in the adult patient population. In order to accurately validate sensors, manipulation of oxygen and nitrogen levels through the administration of oxygen and nitrogen gas will occur. Measurements of SpO2and pulse rate accuracy in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter during motion and non-motion conditions will be taken and analyzed to support development of Nellcor technology and support FDA submission. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04559763
Study type Observational
Source Medtronic - MITG
Contact
Status Completed
Phase
Start date August 18, 2020
Completion date August 21, 2020

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 NCT01922401 - Inverse Ratio Ventilation on Bariatric Operation N/A
Completed NCT02105298 - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study) 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