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Completed

NCT Number: NCT03845192

Oxygen Reserve Index for Kids

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.

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Key information

Conditions

Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johannes Gutenbert University Centre

Mainz, 55131, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • emergency procedures, lack of informed consent of legal guardian

Treatment and study plan

ORI measurement by Radical 97

Device

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 outcomes

  1. time in seconds between ORI-dropping and dropping of SpO2

    Time frame: during general anaesthesia of the infant

    Additionally a potential better definition of ORI-alarm than the preset or previously reported ORI-alarm will be defined

Secondary outcomes

  1. correlation of ORI and PO2

    Time frame: during general anaesthesia of the infant

  2. influence of patient or measurement characteristics on the correlation of ORI and PO2

    Time frame: during general anaesthesia of the infant

  3. 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

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

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

Acronym: ORIkids

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2019
Registry last updated
Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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