Impact of the Transpulmonary Pressure on Right Ventricle Function in Acute Respiratory Distress Syndrome (VD-SDRA)
Primary Purpose
Acute Respiratory Distress Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pneumotachograph
Esophageal catheter
Transthoracic and / or transesophageal cardiac ultrasound
Electrical impedance tomography (EIT) for pediatric patients
Sponsored by
About this trial
This is an interventional other trial for Acute Respiratory Distress Syndrome focused on measuring Acute Respiratory Distress Syndrome, Mechanical ventilation, Transpulmonary pressure, Right ventricle failure
Eligibility Criteria
Inclusion Criteria:
- Patients over one month
- Patients with mild to severe ARDS (onset within 48 hours). ARDS definition will follow Berlin guidelines for adults, and Pediatric Acute Lung Injury Consensus Conference (PALICC) guidelines for children
- Signed consent
Exclusion Criteria :
- Neonates less than 28 days-old
- Pregnancy or breastfeeding
- Any contra-indication to esophageal manometry (less than one month esophagus surgery, bronchopleural or esotracheal fistula, latex allergy)
- No social care
Sites / Locations
- Hôpital Ambroise ParéRecruiting
- Hôpital Necker-Enfants MaladesRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Acute Respiratory Distress Syndrome
Arm Description
Children of more than one month of age and adults hospitalized in Intensive Care Unit for Acute Respiratory Distress Syndrome.
Outcomes
Primary Outcome Measures
Right ventricle failure
Right ventricle failure is defined, by ultrasound, as a composite criteria associating :
end-diastolic right ventricle/left ventricle area ratio > 0.6 and/or Acute Cor Pulmonale (assocation with a septal dyskinesia),
and/or a tricuspid annular plane systolic excursion < 1,6 cm (adults), z-score < -2 (children),
and/or a doppler-derived tricuspid lateral annular systolic velocity (S wave) < 10 cm/s,
and/or a two-dimensional Fractional Area Change (defined as end-diastolic area - end-systolic area)/end-diastolic area x100) < 35%,
and/or a peak right ventricle free wall 2D strain < -30% (adults), z-score < 2 (children).
Secondary Outcome Measures
Airways pressure
Airways pressure (Paw) will be measured in cmH2O thanks to a pneumotachograph connected to the ventilator.
Oesophageal pressure
Esophageal pressure (Pes) will be measured in cmH2O thanks to an oesophageal balloon catheter introduced in the mid-esophagus of the patient and connected to a manometer.
Transpulmonary pressure calculation
Measurements will be performed at different moments during the respiratory cycle: after an inspiratory pause to evaluate the tele-inspiratory transpulmonary pressure (PL-insp), and after an expiratory pause to evaluate the tele-expiratory transpulmonary pressure (PL-PEP ). The PL-insp will be calculated using the ratio between the elastance of the chest wall (Ecw) and of the respiratory system (Ers) thanks to this formula PL = Paw - Paw x (Ecw/Ers). The PL-exp will be calculated using the ratio between Paw et Pes (PL = Paw - Pes). Transpulmonary pressure will be expressed in cmH2O.
Vaso-Active Inotrope Score (VIS)
Correlation between transpulmonary pressure and morbidity. Vaso-Active Inotrope Score is a hemodynamic score taking into account the cumulative doses of inotropic or vassopressive drugs. It is obtained thanks this calculation : VIS = dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 x epinephrine dose (µg/kg/min) + 10 x milrinone dose (µg/kg/min) + 10000 x vasopressin dose (µg/kg/min) + 100 x norepinephrine dose (µg/kg/min). Its value ranges from zero, which is associated to a better outcome, to the maximum cumulative dose without any limit.
Duration of treatment with vasoactive or inotropic drugs
Number of days under vaso-active or inotropic drugs
Pediatric logistic organ dysfunction score
Pediatric logistic organ dysfunction score is a specific pediatric multiple organ dysfunction score that includes 10 variables corresponding to 5 organ dysfunctions. Values extend from 0 (best outcome) to 33 (worst outcome).
Sepsis-related Organ Function Assessement score
Sepsis-related Organ Function Assessement score is a multiple organ dysfunction score that includes several variables corresponding to 6 organ dysfunctions. Values extend from 0 (best outcome) to 24 (worst outcome).
Invasive and non invasive ventilation free days
Number of invasive and non invasive ventilation free days
Lung and Chest Wall compliance
Lung and chest wall compliances (in mL/cmH2O) will be calculated thanks to the respective ratios tidal volume/(PL-insp - PL-PEP) and tidal volume/(Pes insp - Pes-PEP).
Length of hospitalization
Length of hospitalization in Intensive Care Unit and in hospital in days.
Mortality at 28 days
Death in Intensive Care Unit and at 28 days of hospitalization.
Mortality in Intensive Care Unit
Death in Intensive Care Unit.
Eletrical impedance tomography
Electrical impedance tomography will be monitored only in children. Several methods will be used and compared, based on e.g. pixel information of lung aeration, to assess end-expiratory lung volume (ELLV, in mL) and the distribution of ventilation
Full Information
NCT ID
NCT04184674
First Posted
November 28, 2019
Last Updated
July 12, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04184674
Brief Title
Impact of the Transpulmonary Pressure on Right Ventricle Function in Acute Respiratory Distress Syndrome
Acronym
VD-SDRA
Official Title
Impact of the Transpulmonary Pressure on Right Ventricle Function in Acute Respiratory Distress Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
August 11, 2022 (Anticipated)
Study Completion Date
August 11, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
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
Pulmonary distension induced by mechanical ventilation physiologically alters right ventricle pre and after-load, hence might lead to right ventricle failure. The hypothesis is that in Acute Respiratory Distress Syndrome, the occurence of a right ventricle failure under lung protective ventilation might :
i) be correlated to the transpulmonary pressure level, ii) lead to global heart failure, iii) and extremely result in poor outcome and death.
The primary objective is to test the impact of transpulmonary pressure on right ventricular function in Acute Respiratory Distress Syndrome in adults and children.
Secondary objectives are :
i) to compare thresholds of transpulmonary pressure associated with right ventricle failure between children and adults.
ii) to assess if there is an association between transpulmonary pressure and morbidity and mortality.
- For pediatric patients, a specific monitoring with electrical impedance tomography (EIT) will allow:
To assess if the transpulmonary pressure is associated with the level of regional pulmonary overdistention (or collapse) on electrical impedance tomography.(EIT)
To assess if there is an association between the occurrence of right ventricular failure, and distribution of ventilation on EIT.
Detailed Description
Acute Respiratory Distress Syndrome (ARDS) is an acute inflammatory lung injury associated with a high pulmonary vascular permeability, leading to acute respiratory failure. Positive pressure mechanical ventilation,improves survival but might lead to ventilator-induced lung injury (VILI) and right ventricular failure. This hemodynamic effect is more important when compliance is decreased, especially in ARDS.
The use of long protective ventilation (with low tidal volumes and low plateau pressures) has improved prognosis of ARDS in adult patients. However, tidal volume and plateau pressures do not always reflect the lung deformation and the stress induced by the ventilation; these variables depend on the characteristics of the patient's respiratory system. Therefore, management focuses on ventilation strategies according to these characteristics.
Among tools used to evaluate respiratory physiological parameters, the esophageal pressure measurement is easily feasible at the bedside, and well estimates pleural pressure and pulmonary distension. During invasive ventilation, transpulmonary pressure (PL) can be obtained with the difference between the airway pressure and the esophageal pressure. Calculation of transpulmonary pressure in ARDS allows optimal ventilator management of adult and children treated for ARDS.
Although individualized ventilation techniques have shown some benefits in ARDS, studies have failed to show that survival could be improved by such strategies. This lack of efficacy could be partly explained by the hemodynamic impact of ventilation-induced pulmonary distension. It therefore seems essential to combine a robust assessment of right ventricular function with measurements of transpulmonary pressure in order to know the real hemodynamic impact of positive pressure ventilation in ARDS in adults and children.
The primary objective is to test the impact of transpulmonary pressure on right ventricular functionin ARDS adults and children.
Secondary objectives are :
i) to compare thresholds of transpulmonary pressure associated to right ventricle failure between children and adults ii) to assess if there is an association between transpulmonary pressure and morbidity and mortality.
- For pediatric patients, a specific monitoring with electrical impedance tomography (EIT) will allow:
To assess if the transpulmonary pressure is associated with the level of regional pulmonary overdistention (or collapse) on electrical impedance tomography.(EIT)
To assess if there is an association between the occurrence of right ventricular failure, and distribution of ventilation on EIT.
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, Mechanical ventilation, Transpulmonary pressure, Right ventricle failure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acute Respiratory Distress Syndrome
Arm Type
Other
Arm Description
Children of more than one month of age and adults hospitalized in Intensive Care Unit for Acute Respiratory Distress Syndrome.
Intervention Type
Other
Intervention Name(s)
Pneumotachograph
Intervention Description
Measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management :
The first measurement will be performed 5 minutes after the initial ventilator settings.
Measurements will be repeated systematically at 24 hours, 48 hours and 72 hours of evolution.
An additional measure will be performed at each positive end-expiratory pressure modification (maximum 5 measures).
Intervention Type
Other
Intervention Name(s)
Esophageal catheter
Intervention Description
Measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management
The first measurement will be performed 5 minutes after the initial ventilator settings.
Measurements will be repeated systematically at 24 hours, 48 hours and 72 hours of evolution.
An additional measure will be performed at each positive end-expiratory pressure modification (maximum 5 measures).
Intervention Type
Other
Intervention Name(s)
Transthoracic and / or transesophageal cardiac ultrasound
Intervention Description
The right ventricle systolic function will be assessed thanks to a transthoracic cardiac ultrasound in children, and a transthoracic of a transesophageal cardiac ultrasound in adults :
Measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management :
The first measurement will be performed 5 minutes after the initial ventilator settings.
Measurements will be repeated systematically at 24 hours, 48 hours and 72 hours of evolution.
An additional measure will be performed at each positive end-expiratory pressure modification (maximum 5 measures).
Intervention Type
Other
Intervention Name(s)
Electrical impedance tomography (EIT) for pediatric patients
Intervention Description
For pediatric patients: measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management.
Primary Outcome Measure Information:
Title
Right ventricle failure
Description
Right ventricle failure is defined, by ultrasound, as a composite criteria associating :
end-diastolic right ventricle/left ventricle area ratio > 0.6 and/or Acute Cor Pulmonale (assocation with a septal dyskinesia),
and/or a tricuspid annular plane systolic excursion < 1,6 cm (adults), z-score < -2 (children),
and/or a doppler-derived tricuspid lateral annular systolic velocity (S wave) < 10 cm/s,
and/or a two-dimensional Fractional Area Change (defined as end-diastolic area - end-systolic area)/end-diastolic area x100) < 35%,
and/or a peak right ventricle free wall 2D strain < -30% (adults), z-score < 2 (children).
Time Frame
Three days
Secondary Outcome Measure Information:
Title
Airways pressure
Description
Airways pressure (Paw) will be measured in cmH2O thanks to a pneumotachograph connected to the ventilator.
Time Frame
Three days
Title
Oesophageal pressure
Description
Esophageal pressure (Pes) will be measured in cmH2O thanks to an oesophageal balloon catheter introduced in the mid-esophagus of the patient and connected to a manometer.
Time Frame
Three days
Title
Transpulmonary pressure calculation
Description
Measurements will be performed at different moments during the respiratory cycle: after an inspiratory pause to evaluate the tele-inspiratory transpulmonary pressure (PL-insp), and after an expiratory pause to evaluate the tele-expiratory transpulmonary pressure (PL-PEP ). The PL-insp will be calculated using the ratio between the elastance of the chest wall (Ecw) and of the respiratory system (Ers) thanks to this formula PL = Paw - Paw x (Ecw/Ers). The PL-exp will be calculated using the ratio between Paw et Pes (PL = Paw - Pes). Transpulmonary pressure will be expressed in cmH2O.
Time Frame
Three days
Title
Vaso-Active Inotrope Score (VIS)
Description
Correlation between transpulmonary pressure and morbidity. Vaso-Active Inotrope Score is a hemodynamic score taking into account the cumulative doses of inotropic or vassopressive drugs. It is obtained thanks this calculation : VIS = dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 x epinephrine dose (µg/kg/min) + 10 x milrinone dose (µg/kg/min) + 10000 x vasopressin dose (µg/kg/min) + 100 x norepinephrine dose (µg/kg/min). Its value ranges from zero, which is associated to a better outcome, to the maximum cumulative dose without any limit.
Time Frame
Three days
Title
Duration of treatment with vasoactive or inotropic drugs
Description
Number of days under vaso-active or inotropic drugs
Time Frame
3 months after hospitalization in Intensive Care Unit
Title
Pediatric logistic organ dysfunction score
Description
Pediatric logistic organ dysfunction score is a specific pediatric multiple organ dysfunction score that includes 10 variables corresponding to 5 organ dysfunctions. Values extend from 0 (best outcome) to 33 (worst outcome).
Time Frame
Three days
Title
Sepsis-related Organ Function Assessement score
Description
Sepsis-related Organ Function Assessement score is a multiple organ dysfunction score that includes several variables corresponding to 6 organ dysfunctions. Values extend from 0 (best outcome) to 24 (worst outcome).
Time Frame
Three days
Title
Invasive and non invasive ventilation free days
Description
Number of invasive and non invasive ventilation free days
Time Frame
3 months after hospitalization in Intensive Care Unit
Title
Lung and Chest Wall compliance
Description
Lung and chest wall compliances (in mL/cmH2O) will be calculated thanks to the respective ratios tidal volume/(PL-insp - PL-PEP) and tidal volume/(Pes insp - Pes-PEP).
Time Frame
Three days
Title
Length of hospitalization
Description
Length of hospitalization in Intensive Care Unit and in hospital in days.
Time Frame
3 months after hospitalization in Intensive Care Unit
Title
Mortality at 28 days
Description
Death in Intensive Care Unit and at 28 days of hospitalization.
Time Frame
28 days
Title
Mortality in Intensive Care Unit
Description
Death in Intensive Care Unit.
Time Frame
3 months after hospitalization in Intensive Care Unit
Title
Eletrical impedance tomography
Description
Electrical impedance tomography will be monitored only in children. Several methods will be used and compared, based on e.g. pixel information of lung aeration, to assess end-expiratory lung volume (ELLV, in mL) and the distribution of ventilation
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over one month
Patients with mild to severe ARDS (onset within 48 hours). ARDS definition will follow Berlin guidelines for adults, and Pediatric Acute Lung Injury Consensus Conference (PALICC) guidelines for children
Signed consent
Exclusion Criteria :
Neonates less than 28 days-old
Pregnancy or breastfeeding
Any contra-indication to esophageal manometry (less than one month esophagus surgery, bronchopleural or esotracheal fistula, latex allergy)
No social care
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meryl Vedrenne-Cloquet, MD
Phone
+33 1 71 39 68 43
Email
meryl.vedrenne@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène Morel
Phone
+33 1 71 19 63 46
Email
helene.morel@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meryl Vedrenne-Cloquet, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brigitte Fauroux, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Ambroise Paré
City
Boulogne-Billancourt
ZIP/Postal Code
92100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Vieillard-Baron, MD, PhD
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meryl Vedrenne-Cloquet, MD
Phone
+33 1 71 39 68 43
Email
meryl.vedrenne@aphp.fr
12. IPD Sharing Statement
Learn more about this trial
Impact of the Transpulmonary Pressure on Right Ventricle Function in Acute Respiratory Distress Syndrome
We'll reach out to this number within 24 hrs