Intensive Care Unit, Intubation, Preoxygenation
Conditions
Keywords
preoxygenation, intubation, end-tidal of oxygen concentration, intensive care unit, critically ill patients
Brief summary
Preoxygenation is recommended before performing tracheal intubation. In intensive care units (ICU) patients, there is no specific recommendation regarding the duration of preoxygenation, which usually is applied for 3 to 5 minutes. Monitoring the effectiveness of preoxygenation with end-tidal oxygen concentration (EtO2) is strongly recommended in the operating room but it is never used in ICUs. The first aim of this pilot study is to assess the effect of the preoxygenation duration on EtO2, and secondarily, as an exploratory objective, to determine whether targeting a given value of EtO2 during preoxygenation might insure a safer intubation than when targeting pulse oximetry (SpO2).
Detailed description
This is a multicenter randomized controlled pilot study. 110 patients who require intubation in the ICU will be randomly assigned, with a 1:1 ratio, to 3 or 5 minutes of preoxygenation duration. EtO2 will be continuously measured but hidden to the clinician. The primary outcome measure will be the obtention of an optimal preoxygenation defined by an EtO2 \>90%. Secondary outcomes include the occurrence of hypoxia and complications during the procedure. A pulse oximetry (SpO2) greater than or equal to 96% (SpO2 ≥ 96%) at the end of preoxygenation will be the target in each group. If at the end of the preoxygenation, SpO2 is still lower than 96%, clinician will be allowed to extend the duration of preoxygenation (up to 5 minutes in the 3 minutes period of preoxygenation group and up to 8 minutes in the 5 minutes period of preoxygenation group). End-tidal oxygen concentration (EtO2) will be measured during preoxygenation and will be hidden to the clinician in order to not influence the duration of preoxygenation.
Interventions
OTHERPreoxygenation
participants will receive 3 minutes of preoxygenation before intubation
OTHERPreoxygenation (longer)
participants will receive 5 minutes of preoxygenation before intubation
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pilot study Randomized controlled multicenter trial Ratio 1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years * Requiring intubation in ICU * Free express oral and informed consent of the patient or a proxy in case of impossibility for the patient to consent; emergency inclusion possible when legal representatives and patient's family are not present
Exclusion criteria
* Intubation for cardiac arrest * End-tidal oxygen concentration monitoring not available * Preoxygenation with high-flow nasal oxygenation * Previous participation to the study * Patient known, at time of inclusion, as being under guardianship, tutorship or curator * Pregnancy or breastfeeding * Lack of social security number
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who reach an EtO2 of 90% | 3 minutes | To compare the percentage of patients who reach an EtO2 of 90% or higher (optimal preoxygenation) at the end of the preoxygenation period between patients randomized in the 3-min and those randomized in the 5-min preoxygenation duration group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypoxemia | 5 minutes after intubation | Hypoxemia will be defined by SpO2\<90% during the intubation procedure |
| Incidence of severe hypoxemia | End of preoxygenation | Severe hypoxemia will be defined by SpO2\<80% for more than 5 seconds during the intubation procedure from the end of preoxygenation to 5 minutes after invasive mechanical ventilation |
| Incidence of severe complications | 30 minutes after intubation | Severs complications occuring within 30 minutes following the intubation procedure will be evaluate and compare between the two groups |
| Expired oxygen fraction (FeO2) | end of the preoxygenation period | FeO2 will be recorded at the end of the preoxygenation period |
| Partial Pressure of Oxygen (PaO2) | 0 minute | Measurement of PaO2 |
| Partial Pressure of Oxygen | at the 4th minute on average (3rd or 5th minute depending on the randomisation group) | Measurement of PaO2 at the end of the preoxygenation |
| Lowest Pulsed saturation with Oxygen (SpO2) | 30 minutes after the end of preoxygenation | The lowest SPO2 obtained within 30 minutes after the end of preoxygenation will be compared between the 2 groups |
Countries
France
Outcome results
None listed