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Validate a New OXYGEN RESERVE INDEX (ORI)


- candidate number21594
- NTR NumberNTR5047
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jan-2015
- Secondary IDsORI-001 
- Public TitleValidate a New OXYGEN RESERVE INDEX (ORI)
- Scientific TitleA Single-Center, Prospective Study in Healthy Subjects to Validate a New OXYGEN RESERVE INDEX (ORI)
- ACRONYM
- hypothesisMonitoring 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.
- Healt Condition(s) or Problem(s) studiedOxygen Reserve Index
- 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
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 15-mrt-2015
- planned closingdate30-jun-2015
- Target number of participants20
- 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 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%)
- Primary outcomeValidation 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).
- Timepointsduring 4 hours
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES R. Spanjersberg
- CONTACT for SCIENTIFIC QUERIES R. Spanjersberg
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD20-jan-2015 - 18-apr-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl