Weaning-induced Pulmonary Edema
Conditions
Keywords
Weaning-induced pulmonary edema
Brief summary
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.
Interventions
PROCEDURET-piece SBT
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).
PROCEDUREPS-ZEEP SBT
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).
Sponsors
University Hospital, Limoges
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient (\> 18 years) on invasive mechanical ventilation in the ICU for more than 48 hours * In the ventilator weaning phase with a first SBT planned * At risk of WIPE: age over 65 years and/or any type of heart disease and/or chronic respiratory failure and/or obesity
Exclusion criteria
* Patient who has already participated in the study * No transthoracic echocardiographic images suitable for analysis * Non-sinus rhythm (including pacemaker) * Tracheostomy * Chronic neuromuscular or neurodegenerative disease * Persons deprived of liberty or under legal protection * Pregnant or breastfeeding woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| E/e' ratio | Day 1 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in the averaged E/e' ratio | Day1 | 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 |
| Absolute change in arterial pressure | day 1 | The absolute change in arterial pressure between the baseline period and the end of the SBT |
| Relative change in arterial pressure | Day 1 | The relative change in arterial pressure between the baseline period and the end of the SBT |
| Number of WIPE cases | Day 1 | The number of WIPE cases |
| Proportion of WIPE cases | Day 1 | The proportion of WIPE cases |
| Number of SBT interruptions | Day 1 | The number of SBT interruptions related to WIPE |
| Absolute change in peak velocity of the mitral E wave | Day 1 | The absolute change in the peak velocity of the mitral E wave at the lateral and septal mitral annulus |
| Relative change in peak velocity of the mitral E wave | Day 1 | The relative change in the peak velocity of the mitral E wave at the lateral and septal mitral annulus |
| Relative change in peak velocity of the mitral e' wave | Day 1 | The relative change in the peak velocity of the mitral e' wave at the lateral and septal mitral annulus |
| Absolute change in peak velocity of the mitral e' wave | Day 1 | The absolute change in the peak velocity of the mitral e' wave at the lateral and septal mitral annulus |
| Absolute change in peak velocity of tricuspid regurgitation | Day 1 | The absolute change in the peak velocity of tricuspid regurgitation |
| Relative change in peak velocity of tricuspid regurgitation | Day 1 | The relative change in the peak velocity of tricuspid regurgitation |
| Number of clinically relevant mitral regurgitation | Day 1 | 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 |
| Proportion of clinically relevant mitral regurgitation | Day 1 | 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 |
| Semi-quantitative assessment of clinically relevant mitral regurgitation | Day 1 | 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 |
| Number of dynamic left ventricular outflow tract obstruction | Day 1 | 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 |
| Proportion of dynamic left ventricular outflow tract obstruction | Day 1 | 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 |
| Semi-quantitative assessment of dynamic left ventricular outflow tract obstruction | Day 1 | 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 |
| Lung ultrasound aeration score | Day 1 | The lung ultrasound aeration score (0 to 3) across all 12 quadrants between the baseline period and the end of the SBT |
| The number of SBTs performed | Day 1 | The number of SBTs performed before extubation |
| The type of SBTs performed | Day 1 | The type of SBTs performed before extubation |
| Duration of such ventilatory support | Day 1 | The Duration of such ventilatory support |
| Number of patients requiring ventilatory support | Day 1 | The number of patients requiring ventilatory support with high-flow oxygen therapy (e.g., Optiflow©) or non-invasive ventilation |
| Number of patients requiring reintubation for mechanical ventilation | Day 7 | The number of patients requiring reintubation for mechanical ventilation within the week following extubation (extubation failure); the day of reintubation, where applicable |
| The number of hours between the second SBT and extubation | Day 1 | The number of hours between the second SBT and extubation |
| Description of the therapeutic changes | Day 1 | A description of the therapeutic changes introduced after the second SBT and before extubation |
| Relative change in hematocrit | Day 1 | The relative change in hematocrit, between the baseline period and the end of the SBT |
| Absolute change in NT-pro-BNP | Day 1 | The absolute change in NT-pro-BNP, between the baseline period and the end of the SBT |
| Absolute change in hematocrit | Day 1 | The absolute change in hematocrit, between the baseline period and the end of the SBT |
| Relative change in NT-pro-BNP | Day 1 | The relative change in NT-pro-BNP, between the baseline period and the end of the SBT |
| Relative change in total plasma protein levels | Day 1 | The relative change in total plasma protein levels, between the baseline period and the end of the SBT |
| Absolute change in total plasma protein levels | Day 1 | The absolute change in total plasma protein levels, between the baseline period and the end of the SBT |
Countries
France
Outcome results
None listed