Fluid Responsiveness Predicted by a Stepwise PEEP Elevation Recruitment Maneuver in Mechanically Ventilated Patients (STEP-PEEP)

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

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.

Study Overview

• Status: Completed
• Conditions: Respiration, Artificial; Mechanical Ventilation
• Intervention / Treatment: Procedure: Lung recruitment maneuver

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 Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admited in the intensive care unit of the University Hospital of Saint-Etienne

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intensive care; Patients admitted in the intensive care unit of the University Hospital of Saint-Etienne, France between December 2018 and July 2019	Procedure: Lung recruitment maneuver; Lung recruitment maneuver is 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulse pressure (mmHg)	Pulse pressure = systolic aortic pressure - diastolic aortic pressure	At the inclusion
systolic aortic pressure (mmHg)		At the inclusion
diastolic aortic pressure (mmHg)		At the inclusion

Secondary Outcome Measures

Outcome Measure	Time Frame
mean arterial pressure (mmHg)	At the inclusion
Stroke volume (ml)	At the inclusion
central venous pressure (mmHg)	At the inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Sylvain VALLIER, PhD, CHU de St Etienne

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; fluid responsiveness; central venous pressure; stroke volume; Lung recruitment maneuver; pulse pressure
• Other Study ID Numbers: IRBN902018/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No