Mechanical VentilationSTEP-PEEPNCT04304521
Fluid Responsiveness Predicted by a Stepwise PEEP Elevation Recruitment Maneuver in Mechanically Ventilated Patients
An observational study of Mechanical Ventilation and Respiration, Artificial, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Respiration, Artificial
- What is being tested?
- Lung recruitment maneuver
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2018to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admited in the intensive care unit of the University Hospital of Saint-Etienne
Who may be able to join
- 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
Who cannot join
- right ventricular dysfunction
- significant valvulopathy,
- ejection fraction less than 50%,
- arrhythmia
- contraindication to LRMs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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
- Conditions
- Mechanical Ventilation, Respiration, Artificial
- Being tested
- Lung recruitment maneuver
- Keywords
- Mechanical Ventilation, Lung recruitment maneuver, central venous pressure, pulse pressure, stroke volume, fluid responsiveness
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung recruitment maneuverProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive care | Patients admitted in the intensive care unit of the University Hospital of Saint-Etienne, France between December 2018 and July 2019 Receives: Procedure: Lung recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulse pressure (mmHg)
Pulse pressure = systolic aortic pressure - diastolic aortic pressure
Measured: At the inclusion
systolic aortic pressure (mmHg)
Measured: At the inclusion
diastolic aortic pressure (mmHg)
Measured: At the inclusion
Secondary outcomes (3)
mean arterial pressure (mmHg)
Measured: At the inclusion
Stroke volume (ml)
Measured: At the inclusion
central venous pressure (mmHg)
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Dec 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain VALLIER, PhD, Principal investigator, CHU de St Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304521
- Sponsor's protocol ID
- IRBN902018/CHUSTE
- Acronym
- STEP-PEEP
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34979928
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Responsiveness Predicted by a Stepwise PEEP Elevation Recruitment Maneuver in Mechanically Ventilated Patients, a Pilot Study
- ClinicalTrials.gov ID
- NCT04304521
- Acronym / sponsor ID
- STEP-PEEP / IRBN902018/CHUSTE
- Conditions
- Mechanical Ventilation, Respiration, Artificial
- Keywords
- Mechanical Ventilation, Lung recruitment maneuver, central venous pressure, pulse pressure, stroke volume, fluid responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive care | – | Procedure: Lung recruitment maneuverPatients admitted in the intensive care unit of the University Hospital of Saint-Etienne, France between December 2018 and July 2019 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admited in the intensive care unit of the University Hospital of Saint-Etienne
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- right ventricular dysfunction
- significant valvulopathy,
- ejection fraction less than 50%,
- arrhythmia
- contraindication to LRMs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung recruitment maneuverLung 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. | Procedure or surgery | Intensive care |
Primary outcome
pulse pressure (mmHg)
Time frame: At the inclusion
Pulse pressure = systolic aortic pressure - diastolic aortic pressure
systolic aortic pressure (mmHg)
Time frame: At the inclusion
diastolic aortic pressure (mmHg)
Time frame: At the inclusion
3 secondary outcomes
mean arterial pressure (mmHg)
Time frame: At the inclusion
Stroke volume (ml)
Time frame: At the inclusion
central venous pressure (mmHg)
Time frame: At the inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Derived from this study: PubMed 34979928Vallier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvain VALLIER, PhD principal investigator
CHU de St Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Respiration, Artificial, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulse pressure (mmHg) (time frame: At the inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04304521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020; AzTrials last refreshed its copy on 30 Oct 2026.