Hypoxia Clinical Trial
Official title:
Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia
Validate Non-Motion SpO2 Accuracy from 70%-100% of various pulse oximeter/ sensor combinations and various OEM pulse oximeter modules and sensor combinations during induced hypoxia (desaturation).
The testing is conducted on 12 healthy, consenting, non-smoking subjects in accordance with
the IRB approved Protocol. The subjects shall be distributed across both genders and a range
of skin tones as equally as practical.
An arterial line will be placed in the radial artery of each subject's right arm, and
sensors will be attached to each subject. The subjects will be placed in a semi-supine
position and allowed to breathe through a mouthpiece while the nose is blocked with a
nose-clip.
Hypoxia will be induced by on each subject, as levels of oxyhemoglobin saturation (between
70% and 100%) are achieved by breathing mixtures of nitrogen, room air and carbon dioxide.
Inspired O2 concentration will be adjusted breath-by-breath using a computed saturation,
based on end-tidal PO2 and PCO2, as sampled by a mass spectrometer. Predicted levels of
oxyhemoglobin saturations will be attained and held stable. At a minimum of sixty seconds
into each plateau, a 0.5cc waste blood draw through the arterial line, followed by the first
1.0cc sample blood draw. After approximately thirty additional seconds, the second 1.0cc
sample blood draw will be taken. The samples will immediately be analyzed by a Radiometer
OSM-3 multi-wavelength co-oximeter and recorded. The SpO2 data from the oximeters will be
collected via a laptop computer. Concurrent with the end of each blood draw, a marker will
be generated on the laptop computers to identify the event.
;
Time Perspective: Prospective
| 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 |