MedDataX Logo

Non-invasive Early Oxygen- Reserve-index (ORI) Determination to Prevent Hypoxaemia During Endotracheal Intubation

NCT ID: NCT05867875

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

950 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-06-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether ORI monitoring increases the lowest oxygen saturation level during the interval between the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) and the end of the second minute after successful ETI.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05085119

Intubation Mechanical Ventilation Intensive Care Unit
COMPLETED NA

ORI2 : ORI for hyperOxia Reduction in ICU

NCT02878460

Intensive Care Units
COMPLETED NA

Comparison of Preoxygenation Techniques in Healthy Volunteers With Monitoring of End-tidal Oxygen Fraction (FeO₂) and Oxygen Reserve Index (ORI)

NCT07334041

Healthy
NOT_YET_RECRUITING NA

The Effectiveness of the Use of Oxygen Reserve Index in Preventing Hyperoxia in the Intensive Care Unit.

NCT05807815

Hyperoxia Complication Mechanical Ventilation Complication
COMPLETED NA

A Titration of Fractional Inspired Oxygen Using Oxygen Reserve Index in Child

NCT05912543

Hyperoxemia
COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The trial population will be adults (18 years of age or older) who need endotracheal intubation while hospitalized in ICU

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intensive Care Unit

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Consecutive Intensive Care Unit (ICU) patients requiring ETI will be randomly allocated to ETI with or without ORI monitoring before beginning of preoxygenation, with stratification by centre, expert or nonexpert intubator status (experts: ≥5 years' ICU experience, or ≥1 year ICU experience plus ≥2 years' anaesthesiology training), and Non-Invasive Ventilation (NIV) or others devices for preoxygenation. Randomisation will be via an electronic case-report form, using a balanced scheme with stratification as described above.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators
During intubation procedure, blinded continuous monitoring of SpO2 and ORI (for control group) will be performed by appropriate monitor (Masimo Rad7) with data extraction at regular intervals.

Oxygen saturation will be tracked during ETI by research nurse or assistant nurse dedicated to fill the eCRF. ORI evolution will not be provided to investigators in the standard of care group.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group (ORI)

ORI and SpO2 monitoring values during preoxygenation of patients will be provided to investigator to determine anaesthesia induction initiation. Anesthesic induction is provided after 30 secondes at ORI \> 0.6 and at least 2 min 30 of preoxygenation (so globaly 3 minutes of preoxygenation)

Group Type EXPERIMENTAL

Unblinded ORI values

Intervention Type OTHER

ORI and SpO2 monitoring will be performed using Masimo Rad 7 and both values will be provided to investigator

Standard of care (SoC) group

Only SpO2 values during preoxygenation of patients will be provided to investigator to determine anaesthesia induction initiation. Anesthesic induction is provided at least 3 min of preoxygenation

Group Type OTHER

Blinded ORI values

Intervention Type OTHER

ORI and SpO2 monitoring will be performed using Masimo Rad 7 and only SpO2 values will be provided to investigator

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Unblinded ORI values

ORI and SpO2 monitoring will be performed using Masimo Rad 7 and both values will be provided to investigator

Intervention Type OTHER

Blinded ORI values

ORI and SpO2 monitoring will be performed using Masimo Rad 7 and only SpO2 values will be provided to investigator

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ICU admission and need for ETI to allow mechanical ventilation
* Need for supplemental oxygen (via any device and at any flow rate) to obtain SpO2\>97%
* Patient or next of kin informed about the study and having consented to participation of the patient in the study (patients with coma are unable to consent). If patient is no competent and no next of kin can be contacted during screening for the study, trial inclusion will be completed as an emergency procedure by the ICU physician, in compliance with French law
* Patients affiliated to a social security system

Exclusion Criteria

* Patients participating in intubation research with an oxygenation endpoint will not be eligible for inclusion
* Fiberoptic intubation required according to physician in charge
* Contra-indications to laryngoscopy (e.g., unstable spinal lesion)
* Insufficient time to include and randomise the patient (e.g., because of cardiac arrest)
* Age \<18 years
* Currently pregnant or breastfeeding
* Correctional facility inmate
* Under guardianship, curatorship or under protection of justice
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Angers

Angers, , France

Site Status

CH Argenteuil

Argenteuil, , France

Site Status

CHU Bordeaux

Bordeaux, , France

Site Status

CH du Cotentin

Cherbourg, , France

Site Status

CH Cholet

Cholet, , France

Site Status

APHP - Hôpital Louis Mourier

Colombes, , France

Site Status

CHU de Dijon

Dijon, , France

Site Status

CH d'Haguenau

Haguenau, , France

Site Status

CHD Vendée

La Roche-sur-Yon, , France

Site Status

CH de Versailles

Le Chesnay, , France

Site Status

CHR Lille - Hôpital Roger Salengro

Lille, , France

Site Status

HCL - Hôpital Edouard Herriot

Lyon, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

CHU de Nice

Nice, , France

Site Status

CHR d'Orléans

Orléans, , France

Site Status

Hôpital Saint-Louis

Paris, , France

Site Status

APHP - Hôpital Cochin

Paris, , France

Site Status

CHU de Rennes

Rennes, , France

Site Status

CH de Roanne

Roanne, , France

Site Status

CHRU de Strasbourg

Strasbourg, , France

Site Status

CHRU de Tours

Tours, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Hille H, Le Thuaut A, Asfar P, Quelven Q, Mercier E, Le Meur A, Quenot JP, Lemiale V, Muller G, Cour M, Ferre A, Berge A, Curtiaud A, Touron M, Plantefeve G, Chakarian JC, Ricard JD, Colin G, Orieux A, Girardie P, Jozwiak M, Rouaud M, Juhel C, Reignier J, Lascarrou JB; CRICS-TRIGGERSEP Network. Impact of non-invasive oxygen reserve index versus standard SpO2 monitoring on peripheral oxygen saturation during endotracheal intubation in the intensive care unit: Protocol for the randomized controlled trial NESOI2. PLoS One. 2024 Sep 16;19(9):e0307723. doi: 10.1371/journal.pone.0307723. eCollection 2024.

Reference Type DERIVED
PMID: 39283873 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RC22_0506

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Endotracheal Suctionning During Positive Pressure Extubation in ICU
NCT07130123 RECRUITING NA
The Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia.
NCT05770583 COMPLETED NA
Oxygen Reserve Index in Airway Surgery in Children
NCT05214950 COMPLETED NA
High Flow Oxygen During Spontaneous Breathing Trial in Patients With High Weaning Risk Failure: Impact on the Weaning Course at D7 From the First Spontaneous Breathing Trial.
NCT03689309 COMPLETED NA
PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
NCT01782430 UNKNOWN PHASE2/PHASE3
Preoxygenation Using High Flow Oxygen : Efficacy and Tolerance in Healthy Volunteers
NCT03399695 UNKNOWN NA
PREdicting Failure of Non-inVasIve Ventilatory Support Using Non-invaSIve mONitoring in Non-intubated Patients With Acute Hypoxemic Respiratory Failure or Post-extubation Failure. The PREVISION Study
NCT06716463 RECRUITING
Benefits of Optiflow® Device for Preoxygenation Before Intubation in Acute Hypoxemic Respiratory Failure : The PREOXYFLOW Study
NCT01747109 COMPLETED NA
Impact of Preoxygenation Time on End-tidal Oxygen Concentration and on Hypoxic Events Occurring After Intubation in the Intensive Care Unit.
NCT04148443 WITHDRAWN NA
Lung MORphological Modifications Evaluated by Electrical Impedance Tomography During Preoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation (MORPHEIT Study, an Ancillary Study of PREONIV Trial)
NCT03282331 UNKNOWN NA
Pulmonary Function After Hyperbaric Oxygen Therapy
NCT05088772 COMPLETED
Non Invasive Ventilation Combined to High Flow Nasal Cannula Oxygen for Preoxygenation of Hypoxemic ICU Patients
NCT02530957 COMPLETED NA
Impact of End-tidal Oxygen Monitoring During Preoxygenation Before Intubation for Acute Hypoxemic Respiratory Failure in ICU Setting
NCT06198504 UNKNOWN NA
Electronic Optimization of Inspired Oxygen During Mechanical Ventilation, a Pragmatic Randomized Trial (OPTI-Oxygen)
NCT05923853 SUSPENDED NA
Respiratory Mechanics in Intensive Care Patients
NCT03420417 UNKNOWN NA
Supplemental Oxygen Study
NCT02464917 COMPLETED NA
Comparison of Patient Work of Breathing and Tidal Volumes With High Flow Nasal Cannula Oxygen Therapy and NIV (Non-Invasive Ventilation) After Extubation in the ICU.
NCT04036175 UNKNOWN NA
Optimisation of High Flow Oxygen Therapy Settings During Hypoxaemic Respiratory Distress Based on Non-contact Measurement of Lung Volumes by Depth Camera
NCT06819644 NOT_YET_RECRUITING PHASE3
Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials
NCT06923267 RECRUITING NA
Apneic Oxygenation With High-flow Nasal Oxygenation After Preoxygenation With Noninvasive Ventilation Before Intubation in Hypoxemic Patients in Intensive Care Unit.
NCT07189338 NOT_YET_RECRUITING NA
Respiratory Variability and Dyspnea During Spontaneous Breathing Trial
NCT05762614 COMPLETED
Prediction of PaO2 Values Using the PRoPERLy II Database
NCT06589427 COMPLETED
Evaluation of Oxygen Consumption and Energy Expenditure During Spontaneous Breathing Trial.
NCT01757093 COMPLETED NA
Comparison of Pre-oxygenation of NIV and HFNC Therapy for Intubation of ICU Patients With Acute Respiratory Failure
NCT02668458 COMPLETED NA
Effect of Intermittent Hypoxia on Ventilatory Endurance in Healthy Volunteers
NCT06714435 COMPLETED NA