Validate a New OXYGEN RESERVE INDEX (ORI)

A Single-Center, Prospective Study in Healthy Subjects to Validate a New OXYGEN RESERVE INDEX (ORI)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20848

Enrollment

Registered

2015-01-20

Start date

2015-03-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxygen Reserve Index

Interventions

•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 f

Eligibility

Inclusion criteria

Inclusion criteria: • Age between 18 and 45 years • Written informed consent • Healthy subjects

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
•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).	—

Contacts

Public ContactR. Spanjersberg

Hanzeplein 1

r.spanjersberg@umcg.nl+31 (0)50 3611158

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)