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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
Johannes Gutenberg University Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypoxia

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
February 15, 2019
Last Updated
September 2, 2021
Sponsor
Johannes Gutenberg University Mainz
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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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