Oxygen Reserve Index for Kids

Hypoxia Clinical Trial

— ORIkids  

Official title:

Application and Validation of the New Oxygen Reserve Index in Infants < 2 Years Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845192
• Other study ID #: ORIkids
• Status: Completed
• Phase: N/A
• Start date: February 19, 2019
• Est. completion date: May 20, 2020

Study information

• Verified date: September 2021
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 20, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

Inclusion Criteria:

• small infants < 2 years scheduled for elective surgery with general anaesthesia.

Exclusion Criteria:

• emergency procedures, lack of informed consent of legal guardian

Related Conditions & MeSH terms

• Hypoxia

Intervention

Device:
• ORI measurement by Radical 97
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®.

Locations

Country	Name	City	State
Germany	Johannes Gutenbert University Centre	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	during general anaesthesia of the infant
Secondary	correlation of ORI and PO2		during general anaesthesia of the infant
Secondary	influence of patient or measurement characteristics on the correlation of ORI and PO2		during general anaesthesia of the infant
Secondary	influence of measurement site on the correlation or ORI with PO2 and the influence of the measurement site on ORI measurement		during general anaesthesia of the infant