Clinical Trials Logo

Clinical Trial Summary

This study will determine if the replacement of the measured arterial blood oxygen saturation with expired (end-tidal) oxygen value is an acceptable method to calculate the accuracy of pulse oximeters.


Clinical Trial Description

Pulse oximeters are non-invasive devices that use light to display an estimate (denoted by SpO2) of the true arterial blood oxygen saturation (SaO2). The accuracy of the pulse oximeter is determined from desaturation sequences (reduction in SpO2 from 100 to 70%) performed in healthy volunteers. The current standard desaturation sequence is a step-wise reduction in 5% SpO2 increments, achieved by reduction in inspired oxygen delivered by a gas blender such as the ROBD (Reduced Oxygen Breathing Device). This mixes oxygen and nitrogen (components of air) to produce the desired gas mixture. Throughout the desaturation sequence arterial blood gas samples are drawn at each step. The blood gas samples are processed through a co-oximeter to measure the SaO2. For each SaO2 measurement there will be a corresponding SpO2 recorded. All data points from all subjects are amalgamated together to allow calculation of how well SpO2 corresponds to the SaO2 throughout the range of 70 - 100% oxygen saturation. Accuracy, A[RMS], is the unit of measure and this incorporates both bias and precision. When the ROBD is used in a desaturation sequence, the subjects' arterial blood carbon dioxide (CO2) level will initially be normal (normocapnia). With the reduction in SpO2 during the desaturation sequence, the subjects' breathing rate will increase and this will cause the a physiological reduction in the blood CO2 value (hypocapnia). The extent of hypocapnia will vary from one subject to another. It is not known whether the presence of hypocapnia may have an effect upon the accuracy measurement. The RespirAct is a gas blender which, in contrast to the ROBD, can control both the oxygen level as well as the carbon dioxide level. The end-tidal oxygen level (PAO2) is continuously displayed by the RespirAct during the desaturation sequence. The PAO2 closely approximates to arterial blood oxygen (PaO2) - the degree of closeness will be measured in the study. Through an accepted formula, the SaO2 can be derived from the measured PAO2. The derived SaO2 values can subsequently be used to measure the accuracy of the pulse oximeter. This A[RMS] can then be compared with the A[RMS] calculated from the blood gas co-oximeter PaO2 / SaO2 values. If the accuracies are comparable then this would remove the need for arterial line placement during pulse oximeter validation studies. Eligible healthy volunteers will complete five (5) oxygen desaturation sequences with adjustment of sequence type and/or CO2 level. Two sequences will be delivered by step-wise reduction and two will be delivered by gradual slope. Two sequences will be delivered at normocapnia and two will be delivered at hypocapnia values. The ROBD sequence will be a step-wise reduction with CO2 value set by the subjects' own breathing control. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03628560
Study type Interventional
Source Duke University
Contact
Status Suspended
Phase N/A
Start date September 26, 2018
Completion date January 30, 2023

See also
  Status Clinical Trial Phase
Completed NCT02866578 - Open Lung Protective Ventilation in Cardiac Surgery N/A
Recruiting NCT06139081 - Oxygen Delivery Methods of Nasal Catheter on the Incidence of Hypoxemia in Patients With Painless Gastroscopy N/A
Not yet recruiting NCT05964309 - Pre-oxygenation in Sitting Position and Oxygen Reserve Index N/A
Completed NCT00740220 - Reproducibility of 6 Minute Walk Tests for Oxygen Desaturation N/A
Completed NCT00675415 - Does Capnography Prevent Hypoxemia During Endoscopic Retrograde Cholangiopancreatography and Endoscopic Ultrasound? N/A
Completed NCT04557605 - Effects of a Face Mask on Oxygenation During Exercise N/A
Active, not recruiting NCT05479929 - Work of Breathing Assessment in Triage Scale
Recruiting NCT05422430 - Rebreathing-induced Hypoxia and Glucose Levels N/A
Not yet recruiting NCT06102499 - Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Recruiting NCT03009643 - Salvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic Surgery N/A
Completed NCT01949012 - Capnography Monitoring During Intravenous Conscious Sedation Sedation With Midazolam for Oral Surgery N/A
Completed NCT01477450 - Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects N/A
Completed NCT01470170 - Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy Phase 4
Recruiting NCT06085859 - Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment N/A
Recruiting NCT03969615 - SuperNO2VA™ and General Anesthesia Postoperative Care N/A
Completed NCT02554110 - Peripheral Nerve Stimulation to Reduce Hypoxic Events N/A
Completed NCT04998253 - Effects in Oxygenation and Hypoxic Pulmonary Vasoconstriction in ARDS Secondary to SARS-CoV2 Early Phase 1
Completed NCT04566419 - poStoperative Anesthesia Care: Facial Mask vs Hfnc and Thoracic Ultrasound for Reduction of Atelectasis Incidence N/A
Recruiting NCT04079465 - Automated Oxygen Control by O2matic to Patients Admitted With Acute Hypoxemia N/A
Recruiting NCT06022523 - Accuracy of Pulse Oximeters With Profound Hypoxia N/A