Fluid Responsiveness Predicted by a Stepwise PEEP Elevation Recruitment Maneuver in Mechanically Ventilated Patients

Completed

• Conditions: Mechanical Ventilation; Respiration, Artificial
• Interventions: Procedure: Lung recruitment maneuver

• Registration Number: NCT04304521
• Lead Sponsor: Centre Hospitalier Universitaire de 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

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2020-03
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-11
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intensive care	Lung recruitment maneuver	Patients admitted in the intensive care unit of the University Hospital of Saint-Etienne, France between December 2018 and July 2019

Primary Outcome Measures

Name	Time	Method
pulse pressure (mmHg)	At the inclusion	Pulse pressure = systolic aortic pressure - diastolic aortic pressure
systolic aortic pressure (mmHg)	At the inclusion
diastolic aortic pressure (mmHg)	At the inclusion

Secondary Outcome Measures

Name	Time	Method
mean arterial pressure (mmHg)	At the inclusion
Stroke volume (ml)	At the inclusion
central venous pressure (mmHg)	At the inclusion

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-Étienne, France