Hypoxia Clinical Trial
Official title:
SpO2 Accuracy Validation of the OxySoftN Sensor Via Reference CO-Oximetry in Healthy, Well-Perfused Subjects
To compare prototype pulse oximeter saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from healthy human subjects.
The study utilizes a single-site, physiology laboratory (Clinimark) for non-randomized, prospective, observational studies. The goal is to enroll a minimum of ten subjects. 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 is to validate the SpO2 and pulse rate accuracy in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter during low saturation conditions. This is achieved through paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of 60 % to 100 % SaO22 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 low saturation conditions over a specified saturation range for the OxySoftN pulse oximetry system. ;
| 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 |