Personalized Tidal Volume in ARDS (VT4HEMOD)

Acute Respiratory Distress Syndrome Clinical Trial

— VT4HEMOD  

Official title:

Personalized Tidal Volume According to Cardiopulmonary Interactions in ARDS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05406570
• Other study ID #: 69HCL21_1272
• Secondary ID: 2021-A02996-35
• Status: Recruiting
• Phase: N/A
• Start date: December 29, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Hospices Civils de Lyon
• Contact: Jean-Christophe RICHARD
• Phone: +33 426109272
• Email: j-christophe.richard[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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
• 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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tidal volume	Standardized versus personalized tidal volume	5 hours - This endpoint will be assessed through study completion (approximately 4-5 hours after study inclusion)