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

March 12, 2020 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pulse pressure (mmHg)
Time Frame: At the inclusion
Pulse pressure = systolic aortic pressure - diastolic aortic pressure
At the inclusion
systolic aortic pressure (mmHg)
Time Frame: At the inclusion
At the inclusion
diastolic aortic pressure (mmHg)
Time Frame: At the inclusion
At the inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
mean arterial pressure (mmHg)
Time Frame: At the inclusion
At the inclusion
Stroke volume (ml)
Time Frame: At the inclusion
At the inclusion
central venous pressure (mmHg)
Time Frame: At the inclusion
At the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sylvain VALLIER, PhD, CHU de St Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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