Back to resultsPersonalized Tidal Volume in ARDS (VT4HEMOD) (VT4HEMOD)
Primary Purpose
Acute Respiratory Distress Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Standardized ventilation
Personalized ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Acute Respiratory Distress Syndrome, cardiopulmonary interaction, tidal volume, computed tomography
Eligibility Criteria
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
Sites / Locations
- Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive RéanimationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standardized tidal volume
Personalized tidal volume
Arm Description
Ventilation with tidal volume 6 ml/kg
Ventilation with tidal volume aiming to minimize cardiopulmonary interactions as assessed by pulse pressure variation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Tidal volume
Standardized versus personalized tidal volume
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05406570
Brief Title
Personalized Tidal Volume in ARDS (VT4HEMOD)
Acronym
VT4HEMOD
Official Title
Personalized Tidal Volume According to Cardiopulmonary Interactions in ARDS
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
Acute Respiratory Distress Syndrome, cardiopulmonary interaction, tidal volume, computed tomography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standardized tidal volume
Arm Type
Active Comparator
Arm Description
Ventilation with tidal volume 6 ml/kg
Arm Title
Personalized tidal volume
Arm Type
Experimental
Arm Description
Ventilation with tidal volume aiming to minimize cardiopulmonary interactions as assessed by pulse pressure variation
Intervention Type
Procedure
Intervention Name(s)
Standardized ventilation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Personalized ventilation
Intervention Description
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 Outcome Measure Information:
Title
Tidal hyperinflation
Description
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.
Time Frame
5 minutes - This endpoint will be assessed 5 minutes after ventilatory adjustment
Secondary Outcome Measure Information:
Title
Tidal volume
Description
Standardized versus personalized tidal volume
Time Frame
5 hours - This endpoint will be assessed through study completion (approximately 4-5 hours after study inclusion)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Christophe RICHARD
Phone
+33 426109272
Email
j-christophe.richard@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
William DANJOU
Phone
+33 472071762
Email
william.danjou@chu-lyon.fr
Facility Information:
Facility Name
Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe RICHARD
Phone
+33 426109272
Email
j-christophe.richard@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
William Danjou
Phone
+33 472071762
Email
william.danjou@chu-lyon.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Personalized Tidal Volume in ARDS (VT4HEMOD)
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