Intensive Care UnitNESOI-2NCT05867875
Non-invasive Early Oxygen- Reserve-index (ORI) Determination to Prevent Hypoxaemia During Endotracheal Intubation
A study testing Unblinded ORI values and Blinded ORI values in people with Intensive Care Unit, run by Nantes University Hospital at 21 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit
- What is being tested?
- Unblinded ORI values and Blinded ORI values
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 950 participants
- Where
- 21 sitesFrance
- Study dates
- 1 Aug 2023to 23 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
CHU Angers
Angers, 49933
CH Argenteuil
Argenteuil, 95100
CHU Bordeaux
Bordeaux, 33076
CH du Cotentin
Cherbourg
CH Cholet
Cholet, 49300
APHP - Hôpital Louis Mourier
Colombes, 92700
CHU de Dijon
Dijon, 21033
CH d'Haguenau
Haguenau, 67500
CHD Vendée
La Roche-sur-Yon, 85025
CH de Versailles
Le Chesnay, 78150
CHR Lille - Hôpital Roger Salengro
Lille, 59037
HCL - Hôpital Edouard Herriot
Lyon, 69437
CHU de Nantes
Nantes, 44093
CHU de Nice
Nice, 06202
CHR d'Orléans
Orléans, 45100
Hôpital Saint-Louis
Paris, 75010
APHP - Hôpital Cochin
Paris, 75014
CHU de Rennes
Rennes, 35033
CH de Roanne
Roanne, 43200
CHRU de Strasbourg
Strasbourg, 67091
CHRU de Tours
Tours, 37044
About this study
Official title: Impact of the Non-invasive Oxygen-reserve-index (ORI) Versus Standard of Care on Peripheral Oxygen Saturation (SpO2) During Endotracheal Intubation (ETI) in Intensive Care Unit: Randomised Superiority Multi-center 2 Arms, Open Trial
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.
Read the detailed description
The trial population will be adults (18 years of age or older) who need endotracheal intubation while hospitalized in ICU
- Conditions
- Intensive Care Unit
- Being tested
- Unblinded ORI values, Blinded ORI values
- Keywords
- ORI, intensive care unit, ETI, Masimo Rad7
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unblinded ORI valuesOther
ORI and SpO2 monitoring will be performed using Masimo Rad 7 and both values will be provided to investigator
Blinded ORI valuesOther
ORI and SpO2 monitoring will be performed using Masimo Rad 7 and only SpO2 values will be provided to investigator
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (ORI) | Experimental | 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) Receives: Other: Unblinded ORI values |
| Standard of care (SoC) group | Other | 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 Receives: Other: Blinded ORI values |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI
Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in Experimental and Control groups
Measured: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
Secondary outcomes (2)
Determine whether ORI monitoring increases the lowest oxygen saturation level according to local oximeter.
Lowest oxygen saturation monitored by local oximeter during ETI in Experimental and Control groups are compared to values monitored by Masimo Rad7 in same conditions
Measured: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Body Mass Index (<30 or ≥30)" subgroup
Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in "Body Mass Index" subgroup
Measured: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Aug 2023
- Primary completion26 May 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 950 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867875
- Sponsor's protocol ID
- RC22_0506
- Acronym
- NESOI-2
- Status last verified
- Jul 2025
- First submitted
- 27 Apr 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39283873
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Non-invasive Oxygen-reserve-index (ORI) Versus Standard of Care on Peripheral Oxygen Saturation (SpO2) During Endotracheal Intubation (ETI) in Intensive Care Unit: Randomised Superiority Multi-center 2 Arms, Open Trial
- ClinicalTrials.gov ID
- NCT05867875
- Acronym / sponsor ID
- NESOI-2 / RC22_0506
- Conditions
- Intensive Care Unit
- Keywords
- ORI, intensive care unit, ETI, Masimo Rad7
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 950 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial population will be adults (18 years of age or older) who need endotracheal intubation while hospitalized in ICU
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group (ORI) | Experimental | Other: Unblinded ORI valuesORI 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) |
| Standard of care (SoC) group | Other | Other: Blinded ORI valuesOnly 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unblinded ORI valuesORI and SpO2 monitoring will be performed using Masimo Rad 7 and both values will be provided to investigator | Other | Experimental group (ORI) |
| Blinded ORI valuesORI and SpO2 monitoring will be performed using Masimo Rad 7 and only SpO2 values will be provided to investigator | Other | Standard of care (SoC) group |
Primary outcome
Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI
Time frame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in Experimental and Control groups
2 secondary outcomes
Determine whether ORI monitoring increases the lowest oxygen saturation level according to local oximeter.
Time frame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Body Mass Index (<30 or ≥30)" subgroup
Time frame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Derived from this study: PubMed 39283873Hille 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unblinded ORI values and Blinded ORI values in people with Intensive Care Unit, run by Nantes University Hospital at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI (time frame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05867875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.