Acute Respiratory Distress SyndromeERECTIONNCT04371016
Pulmonary and Ventilatory Effects of Bed Verticalization in Patients With Acute Respiratory Distress Syndrome
A study testing Verticalization (bed) in people with Acute Respiratory Distress Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Acute respiratory distress syndrome (ARDS) is defined using the clinical criteria of bilateral pulmonary opacities on a chest radiograph, arterial hypoxemia (partial pressure of arterial oxygen [PaO2] to fraction of inspired oxygen [FiO2] ratio ≤ 300 mmHg with positive end-expiratory pressure [PEEP] ≥ 5 cmH2O) within… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Verticalization (bed)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2020to 14 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with moderate or severe Acute Respiratory Distress Syndrome (ARDS) (PaO2/FiO2 < 200 mmHg), at their early phase (< 12h), under invasive mechanical ventilation with controlled ventilation (intubation or tracheotomy).
- Patient equipped with an arterial catheter.
- Patient sedated (BIS between 30 and 50) and, if necessary, under neuromuscular blocking agent (TOF < 2/4 at the orbicular) to avoid inspiratory effort.
- Patient hemodynamically optimized following the Swan-Ganz catheter data.
Who cannot join
- Refusal to participate in the proposed study.
- Unavailability of the bed dedicated to verticalization (Total Lift Bed™, VitalGo Systems Inc., Arjo AB)
- Obesity with BMI ≥ 35 kg.m-2
- Significant hemodynamic instability defined as an increase of more than 20% in catecholamine doses in the last hour, despite optimization of blood volume, for a target mean blood pressure between 65 and 75 mmHg.
- Contraindication to the insertion of a nasogastric tube
- Contraindication to the use of the chest electrical impedance tomography
Show all 10Show fewer
- Contraindication to the insertion of a Swan-Ganz catheter
- Contraindication to the application of compression stockings
- Patient under guardianship
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary and Ventilatory Effects of Bed Verticalization in Patients With Acute Respiratory Distress Syndrome: An Exploratory and Pathophysiology Study
Acute respiratory distress syndrome (ARDS) is defined using the clinical criteria of bilateral pulmonary opacities on a chest radiograph, arterial hypoxemia (partial pressure of arterial oxygen [PaO2] to fraction of inspired oxygen [FiO2] ratio ≤ 300 mmHg with positive end-expiratory pressure [PEEP] ≥ 5 cmH2O) within one week of a clinical insult or new or worsening respiratory symptoms, and the exclusion of cardiac failure as the primary cause. ARDS is a fatal condition for intensive care unit (ICU) patients with a mortality between 30 and 40%, and a frequently under-recognized challenge for clinicians. Patients with severe symptoms may retain sequelae that have recently been reported in the literature. These sequelae may include chronic respiratory failure, disabling neuro-muscular disorders, and post-traumatic stress disorder identical to that observed in soldiers returning from war.
The management of a patient with ARDS requires first of all an optimization of oxygenation, which relies primarily on mechanical ventilation, whether invasive or non-invasive (for less severe patients). Since the ARDS network study published in 2000 in the New England Journal of Medicine, it has been internationally accepted that tidal volumes must be reduced in order to limit the risk of alveolar over-distension and ventilator-induced lung injury (VILI). A tidal volume of approximately 6 mL.kg-1 ideal body weight (IBW) should be applied. Routine neuromuscular blockade of the most severe patients (PaO2/FiO2 < 120 mmHg) is usually the rule, although it is increasingly being questioned. Comprehensive ventilatory management is based on the concepts of baby lung and open lung, introduced respectively by Gattinoni and Lachmann. According to these concepts, it must be considered that the lung volume available for mechanical ventilation is very small compared to the healthy lung for a given patient (baby lung) and that the reduction in tidal volume must be associated with the use of sufficient PEEP and alveolar recruitment maneuvers to keep the lung "open" and limit the formation of atelectasis.
Read more
In addition to this optimization of mechanical ventilation, it is possible to reduce the impact of mechanical stress on the lung. The prone position, for example, makes it possible to free from certain visceral and mediastinal constraints, to optimize the distribution of ventilation as well as the ventilation to perfusion ratios.
Thanks to the technological progress of intensive care beds, it is now possible to verticalize ventilated and sedated patients in complete safety. Verticalization could reduce the constraints imposed to the lungs, by reproducing the more physiological vertical station, and thus modifying the distribution of ventilation.
Indeed, in two physiological studies published in 2006 and 2013 in Intensive Care Medicine, 30 to 40% of patients with ARDS appeared to respond to partial body verticalization at 45° and 60° (in a semi-seated or seated position). In addition to improving arterial oxygenation, verticalization appeared to decrease ventilatory stress, related to supine position, and increase alveolar recruitment, with improved lung compliance and end-expiratory lung volume (EELV) over time. Nevertheless, 90° verticalization has never been studied, nor have positions without body flexion (seated or semi-seated). In these studies, only patients with the highest lung compliance appeared to respond. These data support the current hypothesis of subgroups of patients with ARDS with different pathophysiological characteristics (morphological and phenotypic) and therapeutic responses.
The investigators hypothesize that verticalization of patients with ARDS improves ventilatory mechanics by reducing the constraints imposed on the lung (transpulmonary pressure), pulmonary aeration, arterial oxygenation and ventilatory parameters.
The first objective is to study the influence of the bed position of the patient with early ARDS on the variations in respiratory mechanics represented by the transpulmonary driving pressure (ΔPtp). The second objective is to evaluate changes in ventilatory physiology, tolerance and feasibility of verticalization in patients with early ARDS.
Read the detailed description
This is an interventional study evaluating the beneficial impact of verticalization of patients with ARDS on pathophysiological parameters.
This therapeutic study aims to test patient's position using dedicated beds (Total Lift Bed™, VitalGo Systems Inc., Arjo AB). The study consists of comparing pulmonary pathophysiological parameters for different positions (from the strict dorsal decubitus to the vertical, with 30° and 60° steps) in patients with early ARDS of focal and non-focal morphologies, under invasive mechanical ventilation.
The primary outcome is the difference between the transpulmonary driving pressure (ΔPtp) measured at the end of each verticalization step (30th minute) and the basal value measured at the beginning of the protocol, in strict dorsal decubitus (0°).
The minimum number of subjects to enroll in this study is 30 patients with early ARDS, including 15 with focal lung morphology and 15 with non-focal lung morphology. Intermediate analyses are planned every 5 patients in order to reevaluate the needed number of patients.
The use of a dedicated bed (Total Lift Bed™, VitalGo Systems, Inc., Arjo AB) allows the verticalization of patients under sedation and mechanical ventilation up to 90°. The procedure foresees the gradual verticalization of the patients of 0°, 30°, 60° and 90° by steps of 30 minutes. At the end of each position step (0°, 30°, 60° and 90°), measurement of end-expiratory lung impedance (EELI) and chest electrical impedance tomography (EIT) parameters, measurement of esophageal pressures, collection of ventilatory parameters on the ventilator, collection of Swan-Ganz catheter hemodynamic data, measurement of lung shunt by mixed venous and arterial blood gas analyses and measurement of end-expiratory lung volume (EELV) by the N2 washin-washout method.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Verticalization (bed)
- Keywords
- Acute Respiratory Distress Syndrome, Mechanical Ventilation, Verticalization, Intensive Care Unit
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verticalization (bed)Other
The use of a dedicated bed (Total Lift Bed™, VitalGo Systems, Inc., Arjo AB) allows the verticalization of patients under sedation and mechanical ventilation up to 90°. The procedure foresees the gradual verticalization of the patients of 0°, 30°, 60° and 90° by steps of 30 minutes.
At the end of each position step (0°, 30°, 60° and 90°), measurement of end-expiratory lung impedance (EELI) and chest electrical impedance tomography (EIT) parameters, measurement of esophageal pressures, collection of ventilatory parameters on the ventilator, collection of Swan-Ganz catheter hemodynamic data, measurement of lung shunt by mixed venous and arterial blood gas analyses and measurement of end-expiratory lung volume (EELV) by the N2 washin-washout method
| Study group | Role | What they receive |
|---|---|---|
| Verticalization group | Experimental | After checking the availability of the bed dedicated to verticalization (Total Lift Bed™, VitalGo Systems, Inc., Arjo AB), the inclusion and non-inclusion criteria, as well as the morphology of lung injury, the patient is included. The following procedures are performed :
* insertion of an esophageal balloon catheter (Nutrivent®, Sidam)
* installation of an EIT belt in the 4th or 5th intercostal space (Pulmovista® 500, Dräger)
* insertion of a Swan-Ganz catheter
* continuous recording of digital and analogic data
After collecting initial data from the patient in a strict lying position at 0°, successive 30-minutes position steps at 30°, 60° and 90° will be performed. At the end of the 30 minutes, and for each step, all the data is collected. Receives: Other: Verticalization (bed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transpulmonary driving pressure (ΔPtp)
Difference between the transpulmonary driving pressure (ΔPtp) measured at the end of each verticalization step (30th minute) and the basal value measured at the beginning of the protocol, in strict dorsal decubitus (0°).
Measured: At the end of each verticalization step (30th minute)
Secondary outcomes (70)
Pulmonary mechanics
Maximal transpulmonary pressure (alveolar stress)
Measured: Baseline
Pulmonary mechanics
Maximal transpulmonary pressure (alveolar stress)
Measured: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Alveolar strain (Vt/EELV)
Measured: Baseline
Pulmonary mechanics
Alveolar strain (Vt/EELV)
Measured: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Driving pressure
Measured: Baseline
Pulmonary mechanics
Driving pressure
Measured: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Transpulmonary driving pressure
Measured: Baseline
Pulmonary mechanics
Transpulmonary driving pressure
Measured: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Dead space (Vd/Vt)
Measured: Baseline
Pulmonary mechanics
Dead space (Vd/Vt)
Measured: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Pulmonary compliance
Measured: Baseline
Pulmonary mechanics
Pulmonary compliance
Measured: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Pressure-volume curves
Measured: Baseline
Pulmonary mechanics
Pressure-volume curves
Measured: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Recruitable volume
Measured: Baseline
Pulmonary mechanics
Recruitable volume
Measured: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Optimal PEEP (best compliance)
Measured: Baseline
Pulmonary mechanics
Optimal PEEP (best compliance)
Measured: At the end of each verticalization step (30th minute)
Pulmonary mechanics
O2 consumption (VO2)
Measured: Baseline
Pulmonary mechanics
O2 consumption (VO2)
Measured: At the end of each verticalization step (30th minute)
Pulmonary mechanics
CO2 production (VCO2)
Measured: Baseline
Pulmonary mechanics
CO2 production (VCO2)
Measured: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Pulmonary shunt
Measured: Baseline
Pulmonary mechanics
Pulmonary shunt
Measured: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Mechanical power imparted to patient's lungs by ventilator
Measured: Baseline
Pulmonary mechanics
Mechanical power imparted to patient's lungs by ventilator
Measured: At the end of each verticalization step (30th minute)
Chest electrical impedance tomography (EIT)
Center Of Ventilation (COV)
Measured: Baseline
Chest electrical impedance tomography (EIT)
Center Of Ventilation (COV)
Measured: At the end of each verticalization step (30th minute)
Chest electrical impedance tomography (EIT)
Tidal Impedance Variation (TIV)
Measured: Baseline
Chest electrical impedance tomography (EIT)
Tidal Impedance Variation (TIV)
Measured: At the end of each verticalization step (30th minute)
Chest electrical impedance tomography (EIT)
Regional Ventilation Delay (RVD)
Measured: Baseline
Chest electrical impedance tomography (EIT)
Regional Ventilation Delay (RVD)
Measured: At the end of each verticalization step (30th minute)
Chest electrical impedance tomography (EIT)
End Expiratory Lung Impedance (EELI)
Measured: Baseline
Chest electrical impedance tomography (EIT)
End Expiratory Lung Impedance (EELI)
Measured: At the end of each verticalization step (30th minute)
Chest electrical impedance tomography (EIT)
Percentages of over-distended and collapsed alveolar regions.
Measured: Baseline
Chest electrical impedance tomography (EIT)
Percentages of over-distended and collapsed alveolar regions.
Measured: At the end of each verticalization step (30th minute)
Hemodynamics
Heart rate
Measured: Baseline
Hemodynamics
Heart rate
Measured: At the end of each verticalization step (30th minute)
Hemodynamics
Invasive systolic blood pressure
Measured: Baseline
Hemodynamics
Invasive systolic blood pressure
Measured: At the end of each verticalization step (30th minute)
Hemodynamics
Invasive mean blood pressure
Measured: Baseline
Hemodynamics
Invasive mean blood pressure
Measured: At the end of each verticalization step (30th minute)
Hemodynamics
Invasive diastolic blood pressure
Measured: Baseline
Hemodynamics
Invasive diastolic blood pressure
Measured: At the end of each verticalization step (30th minute)
Hemodynamics
Continuous cardiac output
Measured: Baseline
Hemodynamics
Continuous cardiac output
Measured: At the end of each verticalization step (30th minute)
Hemodynamics
Pulmonary systolic arterial pressures
Measured: Baseline
Hemodynamics
Pulmonary systolic arterial pressures
Measured: At the end of each verticalization step (30th minute)
Hemodynamics
Pulmonary mean arterial pressures
Measured: Baseline
Hemodynamics
Pulmonary mean arterial pressures
Measured: At the end of each verticalization step (30th minute)
Hemodynamics
Pulmonary diastolic arterial pressures
Measured: Baseline
Hemodynamics
Pulmonary diastolic arterial pressures
Measured: At the end of each verticalization step (30th minute)
Hemodynamics
Pulmonary vascular resistance
Measured: Baseline
Hemodynamics
Pulmonary vascular resistance
Measured: At the end of each verticalization step (30th minute)
Hemodynamics
Pulmonary artery occlusion pressure
Measured: Baseline
Hemodynamics
Pulmonary artery occlusion pressure
Measured: At the end of each verticalization step (30th minute)
Hemodynamics
Systolic ejection volume
Measured: Baseline
Hemodynamics
Systolic ejection volume
Measured: At the end of each verticalization step (30th minute)
Hemodynamics
SvO2
Measured: Baseline
Hemodynamics
SvO2
Measured: At the end of each verticalization step (30th minute)
Hemodynamics
End-diastolic volume
Measured: Baseline
Hemodynamics
End-diastolic volume
Measured: At the end of each verticalization step (30th minute)
Hemodynamics
Systemic vascular resistance
Measured: Baseline
Hemodynamics
Systemic vascular resistance
Measured: At the end of each verticalization step (30th minute)
Hemodynamics
Right ventricular end-diastolic volume
Measured: Baseline
Hemodynamics
Right ventricular end-diastolic volume
Measured: At the end of each verticalization step (30th minute)
Hemodynamics
Right ventricular ejection fraction
Measured: Baseline
Hemodynamics
Right ventricular ejection fraction
Measured: At the end of each verticalization step (30th minute)
Blood gases
Arterial and mixed venous blood gases data (PaO2, PaCO2, SaO2, SvO2).
Measured: Baseline
Blood gases
Arterial and mixed venous blood gases data (PaO2, PaCO2, SaO2, SvO2).
Measured: At the end of each verticalization step (30th minute)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start30 Mar 2020
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional study evaluating the beneficial impact of verticalization of patients with ARDS on pathophysiological parameters
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jules Audard, Study chair, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371016
- Sponsor's protocol ID
- RBHP AUDARD 2019
- Acronym
- ERECTION
- Status last verified
- Aug 2026
- First submitted
- 24 Apr 2020
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bouchant L, Godet T, Arpajou G, Aupetitgendre L, Cayot S, Guerin R, Jabaudon M, Verlhac C, Blondonnet R, Borao L, Pereira B, Constantin JM, Bazin JE, Futier E, Audard J. Physiological effects and safety of bed verticalization in patients with acute respiratory distress syndrome. Crit Care. 2024 Aug 5;28(1):262. doi: 10.1186/s13054-024-05013-y.
PubMed 39103928
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary and Ventilatory Effects of Bed Verticalization in Patients With Acute Respiratory Distress Syndrome: An Exploratory and Pathophysiology Study
- ClinicalTrials.gov ID
- NCT04371016
- Acronym / sponsor ID
- ERECTION / RBHP AUDARD 2019
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome, Mechanical Ventilation, Verticalization, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute respiratory distress syndrome (ARDS) is defined using the clinical criteria of bilateral pulmonary opacities on a chest radiograph, arterial hypoxemia (partial pressure of arterial oxygen [PaO2] to fraction of inspired oxygen [FiO2] ratio ≤ 300 mmHg with positive end-expiratory pressure [PEEP] ≥ 5 cmH2O) within one week of a clinical insult or new or worsening respiratory symptoms, and the exclusion of cardiac failure as the primary cause. ARDS is a fatal condition for intensive care unit (ICU) patients with a mortality between 30 and 40%, and a frequently under-recognized challenge for clinicians. Patients with severe symptoms may retain sequelae that have recently been reported in the literature. These sequelae may include chronic respiratory failure, disabling neuro-muscular disorders, and post-traumatic stress disorder identical to that observed in soldiers returning from war.
The management of a patient with ARDS requires first of all an optimization of oxygenation, which relies primarily on mechanical ventilation, whether invasive or non-invasive (for less severe patients). Since the ARDS network study published in 2000 in the New England Journal of Medicine, it has been internationally accepted that tidal volumes must be reduced in order to limit the risk of alveolar over-distension and ventilator-induced lung injury (VILI). A tidal volume of approximately 6 mL.kg-1 ideal body weight (IBW) should be applied. Routine neuromuscular blockade of the most severe patients (PaO2/FiO2 < 120 mmHg) is usually the rule, although it is increasingly being questioned. Comprehensive ventilatory management is based on the concepts of baby lung and open lung, introduced respectively by Gattinoni and Lachmann. According to these concepts, it must be considered that the lung volume available for mechanical ventilation is very small compared to the healthy lung for a given patient (baby lung) and that the reduction in tidal volume must be associated with the use of sufficient PEEP and alveolar recruitment maneuvers to keep the lung "open" and limit the formation of atelectasis.
In addition to this optimization of mechanical ventilation, it is possible to reduce the impact of mechanical stress on the lung. The prone position, for example, makes it possible to free from certain visceral and mediastinal constraints, to optimize the distribution of ventilation as well as the ventilation to perfusion ratios.
Thanks to the technological progress of intensive care beds, it is now possible to verticalize ventilated and sedated patients in complete safety. Verticalization could reduce the constraints imposed to the lungs, by reproducing the more physiological vertical station, and thus modifying the distribution of ventilation.
Indeed, in two physiological studies published in 2006 and 2013 in Intensive Care Medicine, 30 to 40% of patients with ARDS appeared to respond to partial body verticalization at 45° and 60° (in a semi-seated or seated position). In addition to improving arterial oxygenation, verticalization appeared to decrease ventilatory stress, related to supine position, and increase alveolar recruitment, with improved lung compliance and end-expiratory lung volume (EELV) over time. Nevertheless, 90° verticalization has never been studied, nor have positions without body flexion (seated or semi-seated). In these studies, only patients with the highest lung compliance appeared to respond. These data support the current hypothesis of subgroups of patients with ARDS with different pathophysiological characteristics (morphological and phenotypic) and therapeutic responses.
The investigators hypothesize that verticalization of patients with ARDS improves ventilatory mechanics by reducing the constraints imposed on the lung (transpulmonary pressure), pulmonary aeration, arterial oxygenation and ventilatory parameters.
The first objective is to study the influence of the bed position of the patient with early ARDS on the variations in respiratory mechanics represented by the transpulmonary driving pressure (ΔPtp). The second objective is to evaluate changes in ventilatory physiology, tolerance and feasibility of verticalization in patients with early ARDS.
Detailed description
This is an interventional study evaluating the beneficial impact of verticalization of patients with ARDS on pathophysiological parameters.
This therapeutic study aims to test patient's position using dedicated beds (Total Lift Bed™, VitalGo Systems Inc., Arjo AB). The study consists of comparing pulmonary pathophysiological parameters for different positions (from the strict dorsal decubitus to the vertical, with 30° and 60° steps) in patients with early ARDS of focal and non-focal morphologies, under invasive mechanical ventilation.
The primary outcome is the difference between the transpulmonary driving pressure (ΔPtp) measured at the end of each verticalization step (30th minute) and the basal value measured at the beginning of the protocol, in strict dorsal decubitus (0°).
The minimum number of subjects to enroll in this study is 30 patients with early ARDS, including 15 with focal lung morphology and 15 with non-focal lung morphology. Intermediate analyses are planned every 5 patients in order to reevaluate the needed number of patients.
The use of a dedicated bed (Total Lift Bed™, VitalGo Systems, Inc., Arjo AB) allows the verticalization of patients under sedation and mechanical ventilation up to 90°. The procedure foresees the gradual verticalization of the patients of 0°, 30°, 60° and 90° by steps of 30 minutes. At the end of each position step (0°, 30°, 60° and 90°), measurement of end-expiratory lung impedance (EELI) and chest electrical impedance tomography (EIT) parameters, measurement of esophageal pressures, collection of ventilatory parameters on the ventilator, collection of Swan-Ganz catheter hemodynamic data, measurement of lung shunt by mixed venous and arterial blood gas analyses and measurement of end-expiratory lung volume (EELV) by the N2 washin-washout method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional study evaluating the beneficial impact of verticalization of patients with ARDS on pathophysiological parameters
| Arm | Type | Receives |
|---|---|---|
| Verticalization group | Experimental | Other: Verticalization (bed)After checking the availability of the bed dedicated to verticalization (Total Lift Bed™, VitalGo Systems, Inc., Arjo AB), the inclusion and non-inclusion criteria, as well as the morphology of lung injury, the patient is included. The following procedures are performed : * insertion of an esophageal balloon catheter (Nutrivent®, Sidam) * installation of an EIT belt in the 4th or 5th intercostal space (Pulmovista® 500, Dräger) * insertion of a Swan-Ganz catheter * continuous recording of digital and analogic data After collecting initial data from the patient in a strict lying position at 0°, successive 30-minutes position steps at 30°, 60° and 90° will be performed. At the end of the 30 minutes, and for each step, all the data is collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with moderate or severe Acute Respiratory Distress Syndrome (ARDS) (PaO2/FiO2 < 200 mmHg), at their early phase (< 12h), under invasive mechanical ventilation with controlled ventilation (intubation or tracheotomy).
- Patient equipped with an arterial catheter.
- Patient sedated (BIS between 30 and 50) and, if necessary, under neuromuscular blocking agent (TOF < 2/4 at the orbicular) to avoid inspiratory effort.
- Patient hemodynamically optimized following the Swan-Ganz catheter data.
Key exclusion criteria (10 listed)
- Refusal to participate in the proposed study.
- Unavailability of the bed dedicated to verticalization (Total Lift Bed™, VitalGo Systems Inc., Arjo AB)
- Obesity with BMI ≥ 35 kg.m-2
- Significant hemodynamic instability defined as an increase of more than 20% in catecholamine doses in the last hour, despite optimization of blood volume, for a target mean blood pressure between 65 and 75 mmHg.
- Contraindication to the insertion of a nasogastric tube
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verticalization (bed)The use of a dedicated bed (Total Lift Bed™, VitalGo Systems, Inc., Arjo AB) allows the verticalization of patients under sedation and mechanical ventilation up to 90°. The procedure foresees the gradual verticalization of the patients of 0°, 30°, 60° and 90° by steps of 30 minutes. At the end of each position step (0°, 30°, 60° and 90°), measurement of end-expiratory lung impedance (EELI) and chest electrical impedance tomography (EIT) parameters, measurement of esophageal pressures, collection of ventilatory parameters on the ventilator, collection of Swan-Ganz catheter hemodynamic data, measurement of lung shunt by mixed venous and arterial blood gas analyses and measurement of end-expiratory lung volume (EELV) by the N2 washin-washout method | Other | Verticalization group |
Primary outcome
Transpulmonary driving pressure (ΔPtp)
Time frame: At the end of each verticalization step (30th minute)
Difference between the transpulmonary driving pressure (ΔPtp) measured at the end of each verticalization step (30th minute) and the basal value measured at the beginning of the protocol, in strict dorsal decubitus (0°).
70 secondary outcomes
Pulmonary mechanics
Time frame: Baseline
Pulmonary mechanics
Time frame: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Time frame: Baseline
Pulmonary mechanics
Time frame: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Time frame: Baseline
Pulmonary mechanics
Time frame: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Time frame: Baseline
Pulmonary mechanics
Time frame: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Time frame: Baseline
Pulmonary mechanics
Time frame: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Time frame: Baseline
Pulmonary mechanics
Time frame: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Time frame: Baseline
Pulmonary mechanics
Time frame: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Time frame: Baseline
Pulmonary mechanics
Time frame: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Time frame: Baseline
Pulmonary mechanics
Time frame: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Time frame: Baseline
Pulmonary mechanics
Time frame: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Time frame: Baseline
Pulmonary mechanics
Time frame: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Time frame: Baseline
Pulmonary mechanics
Time frame: At the end of each verticalization step (30th minute)
Pulmonary mechanics
Time frame: Baseline
Pulmonary mechanics
Time frame: At the end of each verticalization step (30th minute)
Chest electrical impedance tomography (EIT)
Time frame: Baseline
Chest electrical impedance tomography (EIT)
Time frame: At the end of each verticalization step (30th minute)
Chest electrical impedance tomography (EIT)
Time frame: Baseline
Chest electrical impedance tomography (EIT)
Time frame: At the end of each verticalization step (30th minute)
Chest electrical impedance tomography (EIT)
Time frame: Baseline
Chest electrical impedance tomography (EIT)
Time frame: At the end of each verticalization step (30th minute)
Chest electrical impedance tomography (EIT)
Time frame: Baseline
Chest electrical impedance tomography (EIT)
Time frame: At the end of each verticalization step (30th minute)
Chest electrical impedance tomography (EIT)
Time frame: Baseline
Chest electrical impedance tomography (EIT)
Time frame: At the end of each verticalization step (30th minute)
Hemodynamics
Time frame: Baseline
Hemodynamics
Time frame: At the end of each verticalization step (30th minute)
Hemodynamics
Time frame: Baseline
Hemodynamics
Time frame: At the end of each verticalization step (30th minute)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 39103928Bouchant L, Godet T, Arpajou G, Aupetitgendre L, Cayot S, Guerin R, Jabaudon M, Verlhac C, Blondonnet R, Borao L, Pereira B, Constantin JM, Bazin JE, Futier E, Audard J. Physiological effects and safety of bed verticalization in patients with acute respiratory distress syndrome. Crit Care. 2024 Aug 5;28(1):262. doi: 10.1186/s13054-024-05013-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jules Audard study chair
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verticalization (bed) in people with Acute Respiratory Distress Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transpulmonary driving pressure (ΔPtp) (time frame: At the end of each verticalization step (30th minute)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04371016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.