Validation of the Relationship Between Oxygenation Parameters and ORI™, in Mechanically Ventilated ICU Patients

NCT05085119 | Completed

• 1 other identifier: RBHP 2019 GODET 3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The ORI™ or Oxygen Reserve Index (Masimo, Irvine, CA, USA) is a non-invasive monitoring system for measuring oxygen reserve. It is a digital sensor (almost identical to the SpO2 sensor) which allows an analysis of the absorption of arterial, venous and capillary components. The measured index, unitless, ranges from 0.00 to 1.00 for moderate hyperoxia levels: from 100 to 200 mmHg. It can alert the clinician to a drop in oxygen stores via the drop in SvO2 before a drop in SpO2 is observed. We propose to carry out a study to elucidate correlation between ORI™ and PaO2.

Conditions

Intubation; Mechanical Ventilation; Intensive Care Unit

Keywords

Oxygen administration; Oxygen blood content; ORI; Intensive care unit; ICU; Mechanical ventilation; Intubation

Outcome Measures

Primary Outcomes (1)

• Correlation between ORI™ and PaO2

  Correlations will be investigated during the last minute of each 10 minutes FiO2 steps

  There will be nine 10 minutes steps. Measurement will be done during the last minute of each 10 minutes step

Secondary Outcomes (4)

• Correlation between ORI™ and PcvO2

  There will be nine 10 minutes steps. Measurement will be done during the last minute of each 10 minutes step

• Correlation between ORI™ and ScvO2

  There will be nine 10 minutes steps. Measurement will be done during the last minute of each 10 minutes step

• Correlation between ORI™ and SaO2

  There will be nine 10 minutes steps. Measurement will be done during the last minute of each 10 minutes step

• Correlation between ORI™ and SpO2

  There will be nine 10 minutes steps. Measurement will be done during the last minute of each 10 minutes step

Study Arms (1)

FiO2 stepwise modifications

EXPERIMENTAL

Intubation ICU patients will be challenged with stepwise modifications of FiO2. The following steps will be done: 30, 40, 60, 80, 100, 80, 60, 40 and 30%.

Procedure: Stepwise modifications of FiO2

Interventions

Stepwise modifications of FiO2 PROCEDURE

FiO2 will be increased stepwise from 30 to 100% (40, 60 and 80%), and then decreased with the same FiO2 reverse steps.

FiO2 stepwise modifications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged over 18 years, admitted in an intensive care unit of the Peri-Operative Medicine Pole of the Clermont-Ferrand University Hospital, under invasive mechanical ventilation (intubation or tracheotomy), whose FiO2 required to obtain an SpO2 \> 95% is ≤ 30%, equipped as part of routine care with an arterial catheter and a central venous catheter in the superior vena cava territory
• BMI \< 30 kg.m-2
• Written consent to participate in the study by the patient or by the trusted person, or the relative if he or she is present.

You may not qualify if:

• Existence of an underlying pulmonary pathology that may alter oxygen diffusion or generate an intra-pulmonary shunt (COPD, emphysema, pneumopathy, ARDS, chronic respiratory failure...)
• Uncontrolled haemodynamic instability defined by an increase of more than 20% in catecholamine dosages during the last hour, despite optimisation of the blood volume according to a pre-established protocol (mini-fluid challenge)
• Patient already included in the study
• Patient's or relative's refusal to participate
• Guardianship or trusteeship patient
• No affiliation to the Social Security system

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (2)

Clermont-Ferrand University Hospital

Clermont-Ferrand, 63000, France

Location

CHU

Clermont-Ferrand, France

Location

Study Officials

• Thomas Godet, MD, PhD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: FiO2 steps will be conducted by study investigator. Participants, care providers and outcomes assessor will remain blinded of FiO2 steps.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Validation study of a non-invasive sensor-type medical device, with comparison to standard paraclinical parameters, with a stepwise modification test of FIO2, in normo- to moderate hyperoxic conditions.

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 20, 2021
• Study Start: February 9, 2021
• Primary Completion: August 10, 2022
• Study Completion: August 10, 2022
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

FR (2)