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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • CHU

    Clermont-Ferrand, 63000

Other trials in France

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.

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 groups in NCT04371016
Study groupRoleWhat they receive
Verticalization groupExperimentalAfter 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.

  1. 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)
  1. Pulmonary mechanics

    Maximal transpulmonary pressure (alveolar stress)

    Measured: Baseline

  2. Pulmonary mechanics

    Maximal transpulmonary pressure (alveolar stress)

    Measured: At the end of each verticalization step (30th minute)

  3. Pulmonary mechanics

    Alveolar strain (Vt/EELV)

    Measured: Baseline

  4. Pulmonary mechanics

    Alveolar strain (Vt/EELV)

    Measured: At the end of each verticalization step (30th minute)

  5. Pulmonary mechanics

    Driving pressure

    Measured: Baseline

  6. Pulmonary mechanics

    Driving pressure

    Measured: At the end of each verticalization step (30th minute)

  7. Pulmonary mechanics

    Transpulmonary driving pressure

    Measured: Baseline

  8. Pulmonary mechanics

    Transpulmonary driving pressure

    Measured: At the end of each verticalization step (30th minute)

  9. Pulmonary mechanics

    Dead space (Vd/Vt)

    Measured: Baseline

  10. Pulmonary mechanics

    Dead space (Vd/Vt)

    Measured: At the end of each verticalization step (30th minute)

  11. Pulmonary mechanics

    Pulmonary compliance

    Measured: Baseline

  12. Pulmonary mechanics

    Pulmonary compliance

    Measured: At the end of each verticalization step (30th minute)

  13. Pulmonary mechanics

    Pressure-volume curves

    Measured: Baseline

  14. Pulmonary mechanics

    Pressure-volume curves

    Measured: At the end of each verticalization step (30th minute)

  15. Pulmonary mechanics

    Recruitable volume

    Measured: Baseline

  16. Pulmonary mechanics

    Recruitable volume

    Measured: At the end of each verticalization step (30th minute)

  17. Pulmonary mechanics

    Optimal PEEP (best compliance)

    Measured: Baseline

  18. Pulmonary mechanics

    Optimal PEEP (best compliance)

    Measured: At the end of each verticalization step (30th minute)

  19. Pulmonary mechanics

    O2 consumption (VO2)

    Measured: Baseline

  20. Pulmonary mechanics

    O2 consumption (VO2)

    Measured: At the end of each verticalization step (30th minute)

  21. Pulmonary mechanics

    CO2 production (VCO2)

    Measured: Baseline

  22. Pulmonary mechanics

    CO2 production (VCO2)

    Measured: At the end of each verticalization step (30th minute)

  23. Pulmonary mechanics

    Pulmonary shunt

    Measured: Baseline

  24. Pulmonary mechanics

    Pulmonary shunt

    Measured: At the end of each verticalization step (30th minute)

  25. Pulmonary mechanics

    Mechanical power imparted to patient's lungs by ventilator

    Measured: Baseline

  26. Pulmonary mechanics

    Mechanical power imparted to patient's lungs by ventilator

    Measured: At the end of each verticalization step (30th minute)

  27. Chest electrical impedance tomography (EIT)

    Center Of Ventilation (COV)

    Measured: Baseline

  28. Chest electrical impedance tomography (EIT)

    Center Of Ventilation (COV)

    Measured: At the end of each verticalization step (30th minute)

  29. Chest electrical impedance tomography (EIT)

    Tidal Impedance Variation (TIV)

    Measured: Baseline

  30. Chest electrical impedance tomography (EIT)

    Tidal Impedance Variation (TIV)

    Measured: At the end of each verticalization step (30th minute)

  31. Chest electrical impedance tomography (EIT)

    Regional Ventilation Delay (RVD)

    Measured: Baseline

  32. Chest electrical impedance tomography (EIT)

    Regional Ventilation Delay (RVD)

    Measured: At the end of each verticalization step (30th minute)

  33. Chest electrical impedance tomography (EIT)

    End Expiratory Lung Impedance (EELI)

    Measured: Baseline

  34. Chest electrical impedance tomography (EIT)

    End Expiratory Lung Impedance (EELI)

    Measured: At the end of each verticalization step (30th minute)

  35. Chest electrical impedance tomography (EIT)

    Percentages of over-distended and collapsed alveolar regions.

    Measured: Baseline

  36. Chest electrical impedance tomography (EIT)

    Percentages of over-distended and collapsed alveolar regions.

    Measured: At the end of each verticalization step (30th minute)

  37. Hemodynamics

    Heart rate

    Measured: Baseline

  38. Hemodynamics

    Heart rate

    Measured: At the end of each verticalization step (30th minute)

  39. Hemodynamics

    Invasive systolic blood pressure

    Measured: Baseline

  40. Hemodynamics

    Invasive systolic blood pressure

    Measured: At the end of each verticalization step (30th minute)

  41. Hemodynamics

    Invasive mean blood pressure

    Measured: Baseline

  42. Hemodynamics

    Invasive mean blood pressure

    Measured: At the end of each verticalization step (30th minute)

  43. Hemodynamics

    Invasive diastolic blood pressure

    Measured: Baseline

  44. Hemodynamics

    Invasive diastolic blood pressure

    Measured: At the end of each verticalization step (30th minute)

  45. Hemodynamics

    Continuous cardiac output

    Measured: Baseline

  46. Hemodynamics

    Continuous cardiac output

    Measured: At the end of each verticalization step (30th minute)

  47. Hemodynamics

    Pulmonary systolic arterial pressures

    Measured: Baseline

  48. Hemodynamics

    Pulmonary systolic arterial pressures

    Measured: At the end of each verticalization step (30th minute)

  49. Hemodynamics

    Pulmonary mean arterial pressures

    Measured: Baseline

  50. Hemodynamics

    Pulmonary mean arterial pressures

    Measured: At the end of each verticalization step (30th minute)

  51. Hemodynamics

    Pulmonary diastolic arterial pressures

    Measured: Baseline

  52. Hemodynamics

    Pulmonary diastolic arterial pressures

    Measured: At the end of each verticalization step (30th minute)

  53. Hemodynamics

    Pulmonary vascular resistance

    Measured: Baseline

  54. Hemodynamics

    Pulmonary vascular resistance

    Measured: At the end of each verticalization step (30th minute)

  55. Hemodynamics

    Pulmonary artery occlusion pressure

    Measured: Baseline

  56. Hemodynamics

    Pulmonary artery occlusion pressure

    Measured: At the end of each verticalization step (30th minute)

  57. Hemodynamics

    Systolic ejection volume

    Measured: Baseline

  58. Hemodynamics

    Systolic ejection volume

    Measured: At the end of each verticalization step (30th minute)

  59. Hemodynamics

    SvO2

    Measured: Baseline

  60. Hemodynamics

    SvO2

    Measured: At the end of each verticalization step (30th minute)

  61. Hemodynamics

    End-diastolic volume

    Measured: Baseline

  62. Hemodynamics

    End-diastolic volume

    Measured: At the end of each verticalization step (30th minute)

  63. Hemodynamics

    Systemic vascular resistance

    Measured: Baseline

  64. Hemodynamics

    Systemic vascular resistance

    Measured: At the end of each verticalization step (30th minute)

  65. Hemodynamics

    Right ventricular end-diastolic volume

    Measured: Baseline

  66. Hemodynamics

    Right ventricular end-diastolic volume

    Measured: At the end of each verticalization step (30th minute)

  67. Hemodynamics

    Right ventricular ejection fraction

    Measured: Baseline

  68. Hemodynamics

    Right ventricular ejection fraction

    Measured: At the end of each verticalization step (30th minute)

  69. Blood gases

    Arterial and mixed venous blood gases data (PaO2, PaCO2, SaO2, SvO2).

    Measured: Baseline

  70. 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.

  1. First posted1 May 2020
  2. Study start30 Mar 2020
  3. Primary completion14 Jan 2021
  4. Study completion14 Jan 2021

Resources

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)
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

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.

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