Effects of Ventilation With Tidal Volume Adjusted on Driving Pressure on Ventilation/Perfusion Ratios and Hemodynamics in ARDS (Hemodriving)

February 5, 2025 updated by: Assistance Publique - Hôpitaux de Paris
The driving pressure (DP) is defined as the pressure above the end-expiratory pressure (PEEP) required to distend the respiratory system by the tidal volume (Vt). It is calculated as follows: DP = Plateau pressure - PEEP. It is also equal to the ratio between the tidal volume and the compliance of the respiratory system (Crs): DP = Vt/Crs. Crs is correlated with end-expiratory lung volume, i.e., the lung volume available to receive the tidal volume. DP allows adaptation of the Vt to the available lung volume when the lungs are diseased, rather than to a fraction of lung size when they are healthy, as occurs when tidal volume is adjusted in mL/kg of predicted body weight (PBW). DP is therefore a better reflection of the deformation applied by the tidal volume and the risk of overdistension. It is an important prognostic indicator in acute respiratory distress syndrome (ARDS), with a risk of excess mortality when DP exceeds 14 cm H2O. Conversely, an excessively low DP, suggesting a low tidal volume in relation to the available lung volume, may theoretically also be accompanied by deleterious effects: de-recruitment, atelectrauma, the need to increase respiratory rate, the need for significant sedation, or even curarization. DP and Vt can influence hemodynamics, as overdistension is associated with an increase in dead space and the occurrence of acute cor pulmonale. On the other hand, de-recruitment due to low tidal volume can lead to hypoxic vasoconstriction with an increase in right ventricular afterload.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

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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

It is hypothesized that ventilating ARDS patients with a tidal volume adjusted to mechanical power (MP) rather than 6 ml/kg of predicted body weight (PBW) is associated with improved ventilation/perfusion ratios and better right ventricular loading conditions. The objective is to evaluate the effects of ventilation with a tidal volume adjusted to target driving pressure (DP) between 12 and 14 cmH2O on ventilation/perfusion ratios in ARDS patients. The study consists of a standardization phase where patients receive ventilation with a tidal volume of 6 ml/kg PBW, with PEEP and FiO2 adjusted according to a PEEP/FiO2 table to maintain SpO2 between 90-95%. The respiratory rate will be clinician-adjusted, and settings will be maintained for 30 minutes. Following this, patients will undergo two randomized ventilation steps: (1) Vt-Vent, where settings remain identical to the standardization phase, and (2) DP-Vent, where tidal volume is adjusted to target a DP of 12-14 cmH2O while maintaining the same EtCO2 value as in the Vt-Vent phase. PEEP and FiO2 will remain unchanged. Data collection will begin at the 10th minute of each step.

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 (Estimated)

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.
20

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Créteil, France, 94010
        • Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with ARDS under deep sedation +/- paralized

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • ARDS moderate to severe according to the Berlin criteria
  • Patient receiving continuous sedation and curarization
  • Free and informed consent from the patient or family member

Exclusion Criteria:

  • Pregnancy
  • Adult patient subject to a legal protection measure (tutor, curator, etc.)
  • Patients with a pacemaker, automatic implantable cardioverter defibrillator,
  • Contraindications to thoracic belt placement (e.g., thoracic or spinal cord trauma, recent thoracic surgery)
  • Undrained pneumothorax, bronchopleural fistula
  • Hemodynamic instability (i.e., use of intravenous fluids of more than 10 mL/kg or vasopressors 2 mg/h of norepinephrine or 0.5 mg/h of epinephrine)

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

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
distribution of perfusion and ventilation across VA/Q ratios zones, wasted ventilation and perfusion.
Time Frame: 24 hours
demonstration that ventilate patient with ARDS with an objective of protective driving pressure vent may change VA/Q ratio by using electrical impedance tomography
24 hours

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
Measure Description
Time Frame
DP-vent may induce a modification in patient with right ventricular
Time Frame: 24 hours
RV/LV : right ventricle end-diastolic ratio
24 hours
Change in right ventricular systolic function parameters
Time Frame: 24 hours
Measurement of right ventricular systolic function measured in mmHg
24 hours

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.
Assistance Publique - Hôpitaux de Paris

Study record dates

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Study Major Dates

Study Start (Estimated)

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.
March 3, 2025

Primary Completion (Estimated)

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.
March 5, 2027

Study Completion (Estimated)

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.
April 2, 2027

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).
January 7, 2025

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.
February 5, 2025

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 25, 2025

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 25, 2025

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.
February 5, 2025

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.
February 1, 2025

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.
  • APHP241429

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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