Personalized Tidal Volume in ARDS (VT4HEMOD)

NCT05406570 | Recruiting

• 2 other identifiers: 69HCL21_12722021-A02996-35
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress Syndrome; cardiopulmonary interaction; tidal volume; computed tomography

Outcome Measures

Primary Outcomes (1)

• Tidal hyperinflation

  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.

  5 minutes - This endpoint will be assessed 5 minutes after ventilatory adjustment

Secondary Outcomes (1)

• Tidal volume

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

Study Arms (2)

Standardized tidal volume

ACTIVE COMPARATOR

Ventilation with tidal volume 6 ml/kg

Procedure: Standardized ventilation; Procedure: Personalized ventilation

Personalized tidal volume

EXPERIMENTAL

Ventilation with tidal volume aiming to minimize cardiopulmonary interactions as assessed by pulse pressure variation

Procedure: Standardized ventilation; Procedure: Personalized ventilation

Interventions

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 tidal volume; Standardized tidal volume

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.

Personalized tidal volume; Standardized tidal volume

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Acute cor pulmonale
• ECMO
• Arterial pH \< 7.21 despite respiratory rate set to a maximum of 35/min
• Pneumothorax or bronchopleural fistula
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation

Lyon, 69004, France

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Jean-Christophe RICHARD

CONTACT

+33 426109272; j-christophe.richard@chu-lyon.fr

William DANJOU

CONTACT

+33 472071762; william.danjou@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 6, 2022
• Study Start: December 29, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

FR (1)