Intensive Care Unit
Conditions
Keywords
ORI, intensive care unit, ETI, Masimo Rad7
Brief 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.
Detailed description
The trial population will be adults (18 years of age or older) who need endotracheal intubation while hospitalized in ICU
Interventions
OTHERUnblinded ORI values
ORI and SpO2 monitoring will be performed using Masimo Rad 7 and both values will be provided to investigator
OTHERBlinded ORI values
ORI and SpO2 monitoring will be performed using Masimo Rad 7 and only SpO2 values will be provided to investigator
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine whether ORI monitoring increases the lowest oxygen saturation level according to local oximeter. | 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 monitored by local oximeter during ETI in Experimental and Control groups are compared to values monitored by Masimo Rad7 in same conditions |
| Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in Body Mass Index (<30 or ≥30) subgroup | 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 Body Mass Index subgroup |
Other
| Measure | Time frame | Description |
|---|---|---|
| Determine whether ORI monitoring increases the lowest oxygen saturation level 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 | Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in ORI threshold (\<0.6 or ≥0.6) subgroup |
| Assess safety of ORI monitoring | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI | 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 |
| Assess efficacy of ORI monitoring on ICU mortality | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from intensive care unit or up to 28 days | ICU mortality is assessed in Experimental and Control groups |
| Determine whether ORI monitoring increases the lowest oxygen saturation level 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 | Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in Reason for ETI (hypoxaemia/other) subgroup |
| Assess efficacy of ORI monitoring on ICU stay length | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from intensive care unit or up to 28 days | ICU stay length is assessed in Experimental and Control groups |
| Assess efficacy of ORI monitoring on hospital stay length | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from hospital or up to 28 days | Hospital stay length is assessed in Experimental and Control groups |
| Assess efficacy of ORI monitoring on Mean Cognitive Core at day 28 (modified Telephone Interview for Cognitive Status) | Day 28 | 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 |
| Assess efficacy of ORI monitoring on 28-day mortality | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until day 28 | 28-day mortality is assessed in Experimental and Control groups |
| Determine whether ORI monitoring increases the lowest oxygen saturation level 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 | Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in Shock/No shock (at inclusion) subgroup |
| Determine whether ORI monitoring increases the lowest oxygen saturation level 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 | Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in Difficult Intubation (yes or no) subgroup |
Countries
France
Outcome results
None listed