No registrations found.
ID
Source
Health condition
Oxygen Reserve Index
Sponsors and support
Intervention
Outcome measures
Primary outcome
Validation of the new Oxygen Reserve Index (ORI) by collecting optical data using the Rainbow SET Pulse CO-Oximeter (Masimo Corp.) and comparing them to whole blood references of arterial and venous blood drawn in healthy volunteers
Secondary outcome
•Determination and quantification of the capability of the new Oxygen Reserve Index (ORI) to serve as an early alarm of changes in patient’s oxygen status
•Quantification of the effects of changes in inspired oxygen concentration on
-cerebral tissue oxygenation (as obtained by near infrared spectroscopy, NIRS).
-peripheral tissue oxygenation (as obtained by NIRS).
Study objective
Monitoring a patient’s oxygen status during anesthesia using pulse oximetry is essential. The new Oxygen Reserve Index (ORI) may help provide clinicians real-time visibility to oxygenation in a moderate hypoxic range and serve as a warning of an impending hypoxic state. In this way, ORI may enable proactive interventions to avoid hypoxia.
Study design
during 4 hours
Intervention
•Change in inspiratory oxygen fraction (FiO2):
•Normoxia: room air (FiO2 0.21) (baseline)
•Hyperoxia: 21% to 100% oxygen (FiO2 0.21 to 1.0)
•Hypoxia: breathing mixtures of N2 in air via a tight fitting facemask to reach arterial oxygen saturation levels of 90%, 80%, and eventually 70% as measured by pulse oximetry (Radical 7, Masimo Corp.)
•Change in expiratory carbon dioxide concentration (etCO2) (during normoxia, awake state):
•Normoventilation (etCO2 4.5 – 5 Vol%)
•Partial rebreathing or adding external medical CO2 (target etCO2 7 – 7.5 Vol%)
•Hyperventilation (target etCO2 2.5 – 3 Vol%)
Inclusion criteria
• Age between 18 and 45 years
• Written informed consent
• Healthy subjects
Exclusion criteria
• Pregnant women (female subjects will have a pregnancy test prior to being admitted to the study).
• Presence of any cardiovascular or pulmonary disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4943 |
| NTR-old | NTR5047 |
| Other | : ORI-001 |