Clinical trial NCT04304521: Fluid Responsiveness Predicted by a Stepwise PEEP Elevation Recruitment Maneuver in Mechanically Ventilated Patients
Official title: Fluid Responsiveness Predicted by a Stepwise PEEP Elevation Recruitment Maneuver in Mechanically Ventilated Patients, a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation
Respiration, Artificial
Keywords: Mechanical Ventilation
Lung recruitment maneuver
central venous pressure
pulse pressure
stroke volume
fluid responsiveness
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admited in the intensive care unit of the University Hospital of Saint-Etienne

Brief summary: Hemodynamic and fluid optimization during perioperative period can reduce postoperative morbidity. The assessment of preload and determination of whether the patient is fluid responsive is still challenging. Static preload indices such as central venous pressure are not accurate to assess fluid responsiveness contrary to dynamic preload indices such as pulse pressure variation (PPV) and stroke volume (SV) variation. However, such indices suffer from several limitations and should be used under strict conditions. Alternative dynamic methods such as lung recruitment maneuvers (LRM) have been developed LRM can be used to reopen or prevent collapsed lung under mechanical ventilation so as to decrease respiratory complications. LRM induces a transient increase in intra-thoracic pressure and decreases in venous return, leading to a decrease in left ventricular end-diastolic area and stroke volume. Several studies have shown that the PEEP-induced decrease in stroke volume is related to pre-existing preload responsiveness. Few studies have also shown that LRM can represent a functional test to predict fluid responsiveness. However, monitoring stroke volume during LRM to assess fluid responsiveness is costly, and cardiac output devices may not be reliable. In this context, central venous pressure (CVP) or systemic arterial parameters monitoring are easily accessible and inexpensive during major surgery.

Detailed description: The aims of the current study were

1. to assess the ability of a LRM with a stepwise increase of PEEP to predict fluid responsiveness in mechanically ventilated patients,
2. to identify the best criteria for fluid responsiveness prediction between variations of systolic aortic pressure (SAP), mean arterial pressure (MAP), diastolic aortic pressure (DAP), pulse pressure (PP) and central venous pressure (CVP),
3. to compare the ability of these criteria with pulse pressure variation (PPV) to predict fluid responsiveness

Eligibility criteria: Inclusion Criteria:

* needing invasive arterial blood pressure and pulse contour analysis (PICCO system) for cardiac output measurement,
* central venous pressure monitoring,
* using of protective mechanical ventilation
* Indication for fluid expansion
* Admitted in the intensive care unit of CHU of St ETienne

Exclusion Criteria:

* right ventricular dysfunction
* significant valvulopathy,
* ejection fraction less than 50%,
* arrhythmia
* contraindication to LRMs

Primary outcomes:
measure: pulse pressure (mmHg)
timeFrame: At the inclusion
measure: systolic aortic pressure (mmHg)
timeFrame: At the inclusion
measure: diastolic aortic pressure (mmHg)
timeFrame: At the inclusion
Secondary outcomes:
measure: mean arterial pressure (mmHg)
timeFrame: At the inclusion
measure: Stroke volume (ml)
timeFrame: At the inclusion
measure: central venous pressure (mmHg)
timeFrame: At the inclusion
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de St Etienne
name: Sylvain VALLIER, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vallier S, Bouchet JB, Desebbe O, Francou C, Raphael D, Tardy B, Gergele L, Morel J. Slope analysis for the prediction of fluid responsiveness by a stepwise PEEP elevation recruitment maneuver in mechanically ventilated patients. BMC Anesthesiol. 2022 Jan 3;22(1):4. doi: 10.1186/s12871-021-01544-x.