Personalized Tidal Volume in ARDS (VT4HEMOD) (VT4HEMOD)

Personalized Tidal Volume According to Cardiopulmonary Interactions in ARDS

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)

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Procedure: Standardized ventilation; Procedure: Personalized ventilation

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Christophe RICHARD; Phone Number: +33 426109272; Email: j-christophe.richard@chu-lyon.fr
• Study Contact Backup: Name: William Danjou; Phone Number: +33 472071762; Email: william.danjou@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation
    • Contact: Jean-Christophe RICHARD; Phone Number: +33 426109272; Email: j-christophe.richard@chu-lyon.fr
    • Contact: William Danjou; Phone Number: +33 472071762; Email: william.danjou@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standardized tidal volume; Ventilation with tidal volume 6 ml/kg	Procedure: Standardized ventilation; 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; Procedure: Personalized ventilation; 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.
Experimental: Personalized tidal volume; Ventilation with tidal volume aiming to minimize cardiopulmonary interactions as assessed by pulse pressure variation	Procedure: Standardized ventilation; 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; Procedure: Personalized ventilation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tidal volume	Standardized versus personalized tidal volume	5 hours - This endpoint will be assessed through study completion (approximately 4-5 hours after study inclusion)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Acute Respiratory Distress Syndrome; computed tomography; tidal volume; cardiopulmonary interaction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 69HCL21_1272; 2021-A02996-35 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No