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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41998

Enrollment

Registered

2015-05-27

Start date

2015-09-14

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

zuurstofspanning en zuurstof saturatie bij gezonde vrijwilligers Oxygen Reserve Index pressure of O2

Interventions

Each subject will undergo the following interventions • Change in inspiratory oxygen fraction (FiO2): • Normoxia: room air (FiO2 0.21) (baseline) • Hyperoxia: 100% oxygen (FiO2 1.0) • Hypoxia: breat

hyperoxic

normoxic

oxygen

oxygen reserve index

Eligibility

Age

18 Years to 64 Years

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 o cerebral tissue oxygenation (as obtained by near infrared spectroscopy, NIRS). o peripheral tissue oxygenation (as obtained by NIRS).	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)