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NCT Number: NCT05406570

Personalized Tidal Volume in ARDS (VT4HEMOD)

Treatment of acute respiratory distress syndrome (ARDS) relies on invasive mechanical ventilation with supposedly protective settings (low tidal volume ventilation). Mortality of ARDS remains high in observational studies (40 to 50%). Approximately 30% of ARDS patients exhibit tidal hyperinflation despite low tidal volume ventilation, suggesting that personalization of tidal volume is required to improve ARDS prognostic. To date, reliable bedside tools to adjust tidal volume are lacking. Excessive tidal volume can be detected using computed tomography by quantification of tidal hyperinflation, but this technique is reserved to research studies and requires patient transport to imaging facility.

Mechanical ventilation generates cardio-pulmonary interaction, whose magnitude is influenced by tidal volume and respiratory system characteristics. Pulse pressure variation is a bedside tool with potential to quantify cardio-pulmonary interactions. Increasing tidal volume will decrease right ventricular preload and increase right ventricular afterload, hence maximizing cardio-pulmonary interactions.

The investigators hypothesize that pulse pressure variation might help to detect excessive tidal volume during a tidal volume challenge (i.e. stepwise increase in tidal volume)

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age greater then 18 years old
  • ARDS according to the BERLIN definition with PaO2/FiO2 ratio ≤ 150 mm Hg
  • invasive mechanical ventilation in volume controlled mode with tidal volume set to 6 ml/kg predicted body weight
  • use of sedation and neuromuscular-blocking agents
  • arterial catheter allowing computation of pulse contour cardiac output calibrated with thermodilution
  • central venous catheter implanted in the superior vena cava territory
  • esophageal balloon
  • Computed tomography planned by attending physician

Exclusion criteria

  • Previous inclusion in current study
  • Acute cor pulmonale
  • ECMO
  • Arterial pH < 7.21 despite respiratory rate set to a maximum of 35/min
  • Pneumothorax or bronchopleural fistula
  • Decision to withdraw or withhold life sustaining treatment with 24 hours from inclusion
  • Contra-indication of transport to imaging facility
  • Intracranial hypertension
  • Tricuspid or pulmonary mechanical valve
  • Tricuspid or pulmonary infective endocarditis
  • Pace maker with intracardiac leads
  • Right ventricle tumor
  • Complete left bundle block
  • Intrathoracic metallic device
  • COPD
  • Cardiac arrythmia
  • Vesical pressure > 15 mm Hg
  • Lower limb amputation
  • Inferior vena cava thrombosis
  • Patient under an exclusion period relative to participation to another clinical trial
  • Patient under a legal protective measure
  • Patient not affiliated to social security
  • lac of patient/representative consent
  • Pregnancy
  • Breast feeding

Treatment and study plan

Standardized ventilation

Procedure

Patient will be ventilated with tidal volume 6 mL/kg predicted body weight (PBW) and positive end-expiratory pressure (PEEP) according to the PEEP-FiO2 table of the ARMA trial. A CT scan will be performed with this ventilatory setting and the patients will be switched to the other group

Personalized ventilation

Procedure

Patient will be ventilated with PEEP according to the PEEP-FiO2 table of the ARMA trial. Tidal volume will be selected as the tidal volume minimizing cardiopulmonary interactions as assessed on arterial pressure tracing, during a VT trial. A CT scan will be performed with this ventilatory setting and the patients will be switched to the other group.

Primary outcomes

  1. Tidal hyperinflation

    Time frame: 5 minutes - This endpoint will be assessed 5 minutes after ventilatory adjustment

    Difference between hyperinflated volume in computed tomography images acquired at end-inspiration (defined by the volume of voxels with CT-number < -900) and hyperinflated volume in computed tomography images acquired at end-expiration (defined by the volume of voxels with CT-number < -900). This difference will be standardized to predicted body weight using the formula of the ARMA trial.

Secondary outcomes

  1. Tidal volume

    Time frame: 5 hours - This endpoint will be assessed through study completion (approximately 4-5 hours after study inclusion)

    Standardized versus personalized tidal volume

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Christophe RICHARD

CONTACT

[email protected]

+33 426109272

William DANJOU

CONTACT

[email protected]

+33 472071762

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Personalized Tidal Volume According to Cardiopulmonary Interactions in ARDS

Acronym: VT4HEMOD

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2022
Registry last updated
Nov 19, 2024

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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