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

NCT04304521 | Completed

• 1 other identifier: IRBN902018/CHUSTE
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Respiration, Artificial

Keywords

Mechanical Ventilation; Lung recruitment maneuver; central venous pressure; pulse pressure; stroke volume; fluid responsiveness

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• mean arterial pressure (mmHg)

  At the inclusion

• Stroke volume (ml)

  At the inclusion

• central venous pressure (mmHg)

  At the inclusion

Study Arms (1)

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

Interventions

Lung recruitment maneuver PROCEDURE

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.

Intensive care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Related Publications (1)

• 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.

  PMID: 34979928 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sylvain VALLIER, PhD

  CHU de St Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: December 1, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)