Hemodynamic Impact of the Spontaneous Ventilation Test in Patients at Risk of Weaning Pulmonary Oedema

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Limoges

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient who has already participated in the study

No transthoracic echocardiographic images suitable for analysis

Non-sinus rhythm (including pacemaker)

Tracheostomy

Trial design

Design model

Crossover

Treatments tested in this trial

  • T-piece SBT

    Procedure/Surgery

    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).

  • PS-ZEEP SBT

    Procedure/Surgery

    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).

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: T-piece SBT then PS-ZEEP SBTExperimental treatment 1 intervention
Group B: PS-ZEEP SBT then T-piece SBTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

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
2

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
3

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
4

Number of WIPE cases

The number of WIPE cases

Time frame
Day 1

Other outcomes

Sponsors and contacts

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