NCT03845192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

February 19, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

February 15, 2019

Last Update Submit

September 2, 2021

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • correlation of ORI and PO2

    during general anaesthesia of the infant

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

    during general anaesthesia of the infant

  • 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

Study Arms (1)

ORI measurement by Radical-97

OTHER

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®

Device: ORI measurement by Radical 97

Interventions

ORI measurement by Radical 97DEVICE

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®.

ORI measurement by Radical-97

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • emergency procedures, lack of informed consent of legal guardian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johannes Gutenbert University Centre

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 15, 2019

First Posted

February 19, 2019

Study Start

February 19, 2019

Primary Completion

May 20, 2020

Study Completion

May 20, 2020

Last Updated

September 10, 2021

Record last verified: 2021-09

Locations

DE(1)