Weaning-induced pulmonary edema (WIPE) from the ventilator is a frequent cause of extubation failure or delay, which prolongs the duration of invasive mechanical ventilation and the associated morbidity and mortality. WIPE is a very frequent cause of extubation failure in at-risk patients. A spontaneous breathing trial (SBT) is performed before extubating a patient, either by disconnecting the patient from the ventilator (T-piece SBT) or by setting the ventilator to spontaneous breathing mode with pressure support at 7 cm H2O and zero positive end-expiratory pressure (PS-ZEEP SBT). There is currently no recommendation regarding which SBT modality should be used, particularly in patients at risk of WIPE. The hemodynamic changes induced by the SBT can lead to WIPE, which typically develops within minutes of the SBT onset. The hypothesis being tested is that, by altering intrathoracic pressure during the patient's inspiration (negative pressure), the T-piece SBT leads to a greater increase in left ventricular filling pressures compared to the PS-ZEEP SBT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
88
T-piece SBT will be evaluated first and PS-ZEEP SBT in a second time. If the first SBT fails, regardless of the modality used or the cause of failure, the second SBT will not be performed. The patient will then be managed according to the participating centers' standard of care (treatment guided by the main mechanism of WIPE identified by echocardiography). The two SBTs will be separated by at least 6 hours, during which no therapeutic changes will be made (in case of success at the first SBT). This interval corresponds to the usual SBT schedule (typically one SBT in the morning and one in the afternoon).
In this arm, PS-ZEEP SBT will be evaluated first and T-piece SBT ina second time. If the first SBT fails, regardless of the modality used or the cause of failure, the second SBT will not be performed. The patient will then be managed according to the participating centers' standard of care (treatment guided by the main mechanism of WIPE identified by echocardiography). The two SBTs will be separated by at least 6 hours, during which no therapeutic changes will be made (in case of success at the first SBT). This interval corresponds to the usual SBT schedule (typically one SBT in the morning and one in the afternoon).
Ambroise Paré Hospital -APHP
Boulogne-Billancourt, France
Limoges University hospital
Limoges, France
Nice University Hospital - Archet
Nice, France
Nice university hospital - Pasteur
Nice, France
E/e' ratio
Difference in the percentage change in the averaged E/e' ratio (reflecting changes in left ventricular filling pressures) between the baseline period (just before the start of the SBT) and the end of the SBT (30 minutes if successful, or at the onset of WIPE, whichever occurs first)
Time frame: Day 1
Absolute change in the averaged E/e' ratio
Comparison between patients according to the modality of the first SBT (T-piece SBT vs. PS-ZEEP SBT) of the absolute change in the averaged E/e' ratio between the baseline period and the end of the SBT
Time frame: Day1
Absolute change in arterial pressure
The absolute change in arterial pressure between the baseline period and the end of the SBT
Time frame: day 1
Relative change in arterial pressure
The relative change in arterial pressure between the baseline period and the end of the SBT
Time frame: Day 1
Number of WIPE cases
The number of WIPE cases
Time frame: Day 1
Proportion of WIPE cases
The proportion of WIPE cases
Time frame: Day 1
Number of SBT interruptions
The number of SBT interruptions related to WIPE
Time frame: Day 1
Absolute change in peak velocity of the mitral E wave
The absolute change in the peak velocity of the mitral E wave at the lateral and septal mitral annulus
Time frame: Day 1
Relative change in peak velocity of the mitral E wave
The relative change in the peak velocity of the mitral E wave at the lateral and septal mitral annulus
Time frame: Day 1
Relative change in peak velocity of the mitral e' wave
The relative change in the peak velocity of the mitral e' wave at the lateral and septal mitral annulus
Time frame: Day 1
Absolute change in peak velocity of the mitral e' wave
The absolute change in the peak velocity of the mitral e' wave at the lateral and septal mitral annulus
Time frame: Day 1
Absolute change in peak velocity of tricuspid regurgitation
The absolute change in the peak velocity of tricuspid regurgitation
Time frame: Day 1
Relative change in peak velocity of tricuspid regurgitation
The relative change in the peak velocity of tricuspid regurgitation
Time frame: Day 1
Number of clinically relevant mitral regurgitation
The number (regurgitant jet area ratio on color Doppler with a maximal Nyquist limit, relative to left atrial area) of clinically relevant mitral regurgitation (≥ grade 2) between the baseline period and the end of the SBT
Time frame: Day 1
Proportion of clinically relevant mitral regurgitation
The proportion (regurgitant jet area ratio on color Doppler with a maximal Nyquist limit, relative to left atrial area) of clinically relevant mitral regurgitation (≥ grade 2) between the baseline period and the end of the SBT
Time frame: Day 1
Semi-quantitative assessment of clinically relevant mitral regurgitation
The semi-quantitative assessment (regurgitant jet area ratio on color Doppler with a maximal Nyquist limit, relative to left atrial area) of clinically relevant mitral regurgitation (≥ grade 2) between the baseline period and the end of the SBT
Time frame: Day 1
Number of dynamic left ventricular outflow tract obstruction
The number (measurement of the maximal systolic gradient on continuous-wave Doppler) of dynamic left ventricular outflow tract obstruction between the baseline period and the end of the SBT
Time frame: Day 1
Proportion of dynamic left ventricular outflow tract obstruction
The proportion The number (measurement of the maximal systolic gradient on continuous-wave Doppler) of dynamic left ventricular outflow tract obstruction between the baseline period and the end of the SBT
Time frame: Day 1
Semi-quantitative assessment of dynamic left ventricular outflow tract obstruction
The semi-quantitative assessment (measurement of the maximal systolic gradient on continuous-wave Doppler) of dynamic left ventricular outflow tract obstruction between the baseline period and the end of the SBT
Time frame: Day 1
Lung ultrasound aeration score
The lung ultrasound aeration score (0 to 3) across all 12 quadrants between the baseline period and the end of the SBT
Time frame: Day 1
The number of SBTs performed
The number of SBTs performed before extubation
Time frame: Day 1
The type of SBTs performed
The type of SBTs performed before extubation
Time frame: Day 1
Duration of such ventilatory support
The Duration of such ventilatory support
Time frame: Day 1
Number of patients requiring ventilatory support
The number of patients requiring ventilatory support with high-flow oxygen therapy (e.g., Optiflow©) or non-invasive ventilation
Time frame: Day 1
Number of patients requiring reintubation for mechanical ventilation
The number of patients requiring reintubation for mechanical ventilation within the week following extubation (extubation failure); the day of reintubation, where applicable
Time frame: Day 7
The number of hours between the second SBT and extubation
The number of hours between the second SBT and extubation
Time frame: Day 1
Description of the therapeutic changes
A description of the therapeutic changes introduced after the second SBT and before extubation
Time frame: Day 1
Relative change in hematocrit
The relative change in hematocrit, between the baseline period and the end of the SBT
Time frame: Day 1
Absolute change in NT-pro-BNP
The absolute change in NT-pro-BNP, between the baseline period and the end of the SBT
Time frame: Day 1
Absolute change in hematocrit
The absolute change in hematocrit, between the baseline period and the end of the SBT
Time frame: Day 1
Relative change in NT-pro-BNP
The relative change in NT-pro-BNP, between the baseline period and the end of the SBT
Time frame: Day 1
Relative change in total plasma protein levels
The relative change in total plasma protein levels, between the baseline period and the end of the SBT
Time frame: Day 1
Absolute change in total plasma protein levels
The absolute change in total plasma protein levels, between the baseline period and the end of the SBT
Time frame: Day 1
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