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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.
The trial population will be adults (18 years of age or older) who need endotracheal intubation while hospitalized in ICU
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unblinded ORI values | Other | ORI and SpO2 monitoring will be performed using Masimo Rad 7 and both values will be provided to investigator |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI |
| Measure | Description | Time Frame |
|---|---|---|
| Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Reason for ETI (hypoxaemia/other)" subgroup | Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in "Reason for ETI (hypoxaemia/other)" subgroup | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | 49933 | France | |||
| CH Argenteuil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39283873 | Derived | 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. |
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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.
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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.
| Blinded ORI values | Other | ORI and SpO2 monitoring will be performed using Masimo Rad 7 and only SpO2 values will be provided to investigator |
|
| 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 | 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 "Shock/No shock (at inclusion)" subgroup | Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in "Shock/No shock (at inclusion)" subgroup | 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 "Difficult Intubation (yes or no)" subgroup | Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in "Difficult Intubation (yes or no)" subgroup | 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 "ORI threshold (<0.6 or ≥0.6)" subgroup | Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in "ORI threshold (<0.6 or ≥0.6)" subgroup | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI |
| Assess safety of ORI monitoring | Occurrence of at least one severe life-threatening complication (death, cardiac arrest, arterial systolic pressure <90 mmHg, and/or SpO2<80%) and occurrence of each are assessed in Experimental and Control group | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI |
| Assess efficacy of ORI monitoring on ICU mortality | ICU mortality is assessed in Experimental and Control groups | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from intensive care unit or up to 28 days |
| Assess efficacy of ORI monitoring on 28-day mortality | 28-day mortality is assessed in Experimental and Control groups | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until day 28 |
| Assess efficacy of ORI monitoring on ICU stay length | ICU stay length is assessed in Experimental and Control groups | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from intensive care unit or up to 28 days |
| Assess efficacy of ORI monitoring on hospital stay length | Hospital stay length is assessed in Experimental and Control groups | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from hospital or up to 28 days |
| Assess efficacy of ORI monitoring on Mean Cognitive Core at day 28 (modified Telephone Interview for Cognitive Status) | Mean Cognitive Score at day 28 using modified Telephone Interview for Cognitive Status is assessed in Experimental and Control groups Values range from 0 to 43, with higher scores indicating better cognition | Day 28 |
| Argenteuil |
| 95100 |
| France |
| CHU Bordeaux | Bordeaux | 33076 | France |
| CH du Cotentin | Cherbourg | France |
| CH Cholet | Cholet | 49300 | France |
| APHP - Hôpital Louis Mourier | Colombes | 92700 | France |
| CHU de Dijon | Dijon | 21033 | France |
| CH d'Haguenau | Haguenau | 67500 | France |
| CHD Vendée | La Roche-sur-Yon | 85025 | France |
| CH de Versailles | Le Chesnay | 78150 | France |
| CHR Lille - Hôpital Roger Salengro | Lille | 59037 | France |
| HCL - Hôpital Edouard Herriot | Lyon | 69437 | France |
| CHU de Nantes | Nantes | 44093 | France |
| CHU de Nice | Nice | 06202 | France |
| CHR d'Orléans | Orléans | 45100 | France |
| Hôpital Saint-Louis | Paris | 75010 | France |
| APHP - Hôpital Cochin | Paris | 75014 | France |
| CHU de Rennes | Rennes | 35033 | France |
| CH de Roanne | Roanne | 43200 | France |
| CHRU de Strasbourg | Strasbourg | 67091 | France |
| CHRU de Tours | Tours | 37044 | France |