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Completed

NCT Number: NCT04304521

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

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.

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Key information

Conditions

Mechanical Ventilation Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiration, Artificial Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

About this study

The aims of the current study were

  • to assess the ability of a LRM with a stepwise increase of PEEP to predict fluid responsiveness in mechanically ventilated patients,
  • 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),
  • to compare the ability of these criteria with pulse pressure variation (PPV) to predict fluid responsiveness

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. pulse pressure (mmHg)

    Time frame: At the inclusion

    Pulse pressure = systolic aortic pressure - diastolic aortic pressure

  2. systolic aortic pressure (mmHg)

    Time frame: At the inclusion

  3. diastolic aortic pressure (mmHg)

    Time frame: At the inclusion

Secondary outcomes

  1. mean arterial pressure (mmHg)

    Time frame: At the inclusion

  2. Stroke volume (ml)

    Time frame: At the inclusion

  3. central venous pressure (mmHg)

    Time frame: At the inclusion

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: STEP-PEEP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2020
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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