Oxygen Reserve Index for Kids (ORIkids)
Primary Purpose
Hypoxia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ORI measurement by Radical 97
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypoxia
Eligibility Criteria
Inclusion Criteria:
- small infants < 2 years scheduled for elective surgery with general anaesthesia.
Exclusion Criteria:
- emergency procedures, lack of informed consent of legal guardian
Sites / Locations
- Johannes Gutenbert University Centre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ORI measurement by Radical-97
Arm Description
In this arm ORI measurement is done from the beginning of the induction of anaesthesia until the end of the induction of anaesthesia or until the end of the stay in the operating theatre. The measurement to ORI is done by the "Radical-97" device by Masimo®
Outcomes
Primary Outcome Measures
time in seconds between ORI-dropping and dropping of SpO2
Additionally a potential better definition of ORI-alarm than the preset or previously reported ORI-alarm will be defined
Secondary Outcome Measures
correlation of ORI and PO2
influence of patient or measurement characteristics on the correlation of ORI and PO2
influence of measurement site on the correlation or ORI with PO2 and the influence of the measurement site on ORI measurement
Full Information
NCT ID
NCT03845192
First Posted
February 15, 2019
Last Updated
September 2, 2021
Sponsor
Johannes Gutenberg University Mainz
1. Study Identification
Unique Protocol Identification Number
NCT03845192
Brief Title
Oxygen Reserve Index for Kids
Acronym
ORIkids
Official Title
Application and Validation of the New Oxygen Reserve Index in Infants < 2 Years Old
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
May 20, 2020 (Actual)
Study Completion Date
May 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
In infants less than two years old the new Oxygen Reserve Index (ORI) will be measured during general anaesthesia. It will evaluated if and how ORI-monitoring gives earlier warning of hypoxaemia than conventional oxygen saturation measurement.
Detailed Description
The Oxygen Reserve Index (ORI) is a new development in multiple wavelength pulse oximetry, reflecting the arterial partial oxygen pressure (PaO2) continuously and non-invasively by an index. In contrast to established standard oxygen saturation (SpO2) measurements, ORI detects a drop of PaO2 until the threshold of 100 mmHg. During anaesthesia induction-associated apnoeic periods ORI may detect a drop of PaO2 early enough for the anaesthesiologist to interrupt the intubation procedure and re-start oxygenation. In contrast, due to the flat upper part of the oxyhaemoglobin dissociation curve, SpO2 stays at values above 90% until PaO2 falls below 60mmHg. At this point, SpO2 drops rapidly and a pro- longed hypoxic dip is the consequence. To avoid this potentially harmful hypoxic dip, continuous monitoring of PaO2 using ORI would be advantageous during anaesthesia induction phase.
This clinical study aims to evaluate the time benefit between alarm of hypoxaemia by the ORI-monitoring and the start of the dropping of oxygen saturation. Pre-set and pre-described ORI-alarms will be checked for their utility and a new ORI-alarm will be defined that is potentially more useful. As secondary endpoints the study examines the correlation of ORI with PO2, the influence of patient or measurement characteristics on the correlation of ORI with PO2 and the influence of the measurement site on ORI-measurement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ORI measurement by Radical-97
Arm Type
Other
Arm Description
In this arm ORI measurement is done from the beginning of the induction of anaesthesia until the end of the induction of anaesthesia or until the end of the stay in the operating theatre. The measurement to ORI is done by the "Radical-97" device by Masimo®
Intervention Type
Device
Intervention Name(s)
ORI measurement by Radical 97
Intervention Description
ORI measurement is done from the beginning of the induction of anaesthesia until the end of the induction of anaesthesia or until the end of the stay in the operating theatre. The measurement to ORI is done by the "Radical-97" device by Masimo®.
Primary Outcome Measure Information:
Title
time in seconds between ORI-dropping and dropping of SpO2
Description
Additionally a potential better definition of ORI-alarm than the preset or previously reported ORI-alarm will be defined
Time Frame
during general anaesthesia of the infant
Secondary Outcome Measure Information:
Title
correlation of ORI and PO2
Time Frame
during general anaesthesia of the infant
Title
influence of patient or measurement characteristics on the correlation of ORI and PO2
Time Frame
during general anaesthesia of the infant
Title
influence of measurement site on the correlation or ORI with PO2 and the influence of the measurement site on ORI measurement
Time Frame
during general anaesthesia of the infant
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
small infants < 2 years scheduled for elective surgery with general anaesthesia.
Exclusion Criteria:
emergency procedures, lack of informed consent of legal guardian
Facility Information:
Facility Name
Johannes Gutenbert University Centre
City
Mainz
ZIP/Postal Code
55131
Country
Germany
12. IPD Sharing Statement
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Oxygen Reserve Index for Kids
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