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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
participants will receive 3 minutes of preoxygenation before intubation
participants will receive 5 minutes of preoxygenation before intubation
CH de DAX
Dax, France
CHR d'Orléans
Orléans, France
CHRU de TOURS
Tours, France
Percentage of patients who reach an EtO2 of 90%
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.
Time frame: 3 minutes
Expired oxygen fraction (FeO2)
FeO2 will be recorded at the end of the preoxygenation period
Time frame: end of the preoxygenation period
Incidence of hypoxemia
Hypoxemia will be defined by SpO2\<90% during the intubation procedure
Time frame: 5 minutes after intubation
Incidence of severe hypoxemia
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
Time frame: End of preoxygenation
Incidence of severe complications
Severs complications occuring within 30 minutes following the intubation procedure will be evaluate and compare between the two groups
Time frame: 30 minutes after intubation
Lowest Pulsed saturation with Oxygen (SpO2)
The lowest SPO2 obtained within 30 minutes after the end of preoxygenation will be compared between the 2 groups
Time frame: 30 minutes after the end of preoxygenation
Expired oxygen fraction (FeO2)
FeO2 during preoxygenation will be recorded every minutes
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Time frame: Through preoxygenantion, i.e., an average of 4 minutes (a minimum of 3 and a maximum of 8 minutes)
Partial Pressure of Oxygen (PaO2)
Measurement of PaO2
Time frame: 0 minute
Partial Pressure of Oxygen
Measurement of PaO2 at the end of the preoxygenation
Time frame: at the 4th minute on average (3rd or 5th minute depending on the randomisation group)