Acute Respiratory Distress SyndromeSTAND_ARDS1NCT04472260
Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.
A study testing Verticalization and Prone position in people with Acute Respiratory Distress Syndrome and Prone Position, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
Acute Respiratory Distress Syndrome (ARDS) is defined according to the Berlin definition (1) as diffuse lung damage occurring in patients with a predisposing risk factor. Positioning in the prone position (PP) has been shown to decrease mortality in patients with moderate to severe ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Prone Position
- What is being tested?
- Verticalization and Prone position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2021to 14 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Major patient > 18 years of age
- ARDS patients with PaO2/FiO2 ratio < 150 at any time within 24 hours prior to the screening visit
- Hemodynamically stable patient with mean arterial pressure (MAP) > 65 mmHg maintained without vasopressor or with norepinephrine at a dosage of less than 0.5 µg/kg/min.
- Patient having already undergone at least 1 but less than 5 PP sessions
- Patient under continuous intravenous sedation (IVSE) or not responding to simple order.
- Written consent of support person or family.
Who cannot join
- Pregnant women (positive pregnancy test during screening)
- Breastfeeding women
- Protected Majors
- Body weight greater than 198 kg (bed load limit)
- Patient with one or two lower limbs amputated at the trans tibial or upper level
- Contraindication to standing (orthopedic fracture, neurological instability with the presence of an intracranial pressure sensor or an external ventricular shunt....)
Show all 11Show fewer
- Deep venous thrombosis of the lower limbs with curative anticoagulation for less than 48 hours
- Hemodynamic instability (MAP < 65 mm Hg) despite the use of norepinephrine at a dosage equal or greater than 0.5 µg/kg/min.
- Person under guardianship or trusteeship
- Non-beneficiary patient of a health insurance plan
- Moribund patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHR d'ORLEANS
Orléans
Aurélie DESPUJOLS
May Anh NAY, PH
About this study
Acute Respiratory Distress Syndrome (ARDS) is defined according to the Berlin definition (1) as diffuse lung damage occurring in patients with a predisposing risk factor.
Positioning in the prone position (PP) has been shown to decrease mortality in patients with moderate to severe ARDS.
Read more
However, this technique is not without deleterious effects such as ventilator-associated pneumonia, endotracheal tube obstruction, development of pressure ulcers, and increased workload for the caregivers.
There are other positioning techniques such as the "upright" position, which simulates a relative verticality, which allows to increase the effects of the prone position and even in some patients to improve oxygenation without the PP in the acute phase of ARDS.
However, given the revolution caused by the use of PP in ARDS patients, verticalization have not been studied in more details.
Today, there is a bed on the market that allows patients to be truly upright without having to transfer them to a tilt table.
The investigators believe that raising ARDS patients in the acute phase is safe and feasible in routine practice. In this research protocol comparing PP and verticalization in a crossover trial design in acute ARDS patients, the investigators want to show that this technique can be safe and feasible, with the same effects on oxygenation as PP.
Read the detailed description
Cross-over study, according to 4 preset sequences of 4 periods and randomly assigned. All patients will thus have the classic positioning technique (PP), as well as the technique under study (verticalization). For simplicity, the investigators will use the term "verticalization" even if the final positioning that is targeted is only a "pseudo-verticalization" to a 55° angle. The cross-over scheme with 4 sequences of 4 periods allows to get rid of the first order carry-over effect.
Progressive verticalization protocol in 7 steps from the strict supine position to a 55° inclination of the raising bed, according to the clinical responses of the patient with ARDS, as follows:
- Verticalization in the bed
The verticalization maneuver will take place in 7 steps of 15 minutes maximum each:
S1. The first one corresponds to the flat position (strict dorsal decubitus) S2. The second is the positioning of the patient at 25° of inclination. S3. The third is the 45° positioning S4. The fourth at 55°, which corresponds to the greatest inclination imposed to the patient.
S5. The fifth corresponds to the 45° return S6. The sixth is the return to 25° S7. Finally, the investigators reposition the patient flat back.
Examinations:
- Arterial Gazometry At the beginning, at the end and one hour after each positioning technique.
- Chest ultrasound
- Others All adverse events will be recorded in a clear and detailed manner.
- Being tested
- Verticalization and Prone position
- Keywords
- Acute respiratory distress syndrome, Verticalization, Intensive Care Unit, Prone position
- 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 and Prone positionProcedure or surgery
The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS.
The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: PP->PP->V->V | Other | The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS.
The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours. Receives: Procedure: Verticalization and Prone position |
| Sequence 2: PP->V->V->PP | Other | The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS.
The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours. Receives: Procedure: Verticalization and Prone position |
| Sequence 3: V->PP->PP->V | Other | The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS.
The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours. Receives: Procedure: Verticalization and Prone position |
| Saquence 4: V->V->PP->PP | Other | The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS.
The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours. Receives: Procedure: Verticalization and Prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who were able to reach 55° of verticalization without serious adverse events (with a complete listing of all adverse events).
To demonstrate the feasibility and safety in routine practice of the verticalization technique for patients with moderate to severe ARDS in the acute phase.
Measured: Month 1
Secondary outcomes (3)
PaO2/FiO2 ratio at one hour from the end of the maneuver
To show that verticalization of ARDS patients has the same effects on oxygenation (PaO2/FiO2 ratio) as PP.
In this crossover trial, each sequence of four treatment periods, beginning at time of randomization, will last a maximum of 75,5 hours for each patient. The last assessment will occur at a maximum of 76,5 hours from randomisation.
Measured: Hour 76
Quasi-static compliance in (ml/cmH2O) before, at the end and one hour after each positioning technique
To evaluate the impact of the positioning maneuver on quasi-static thoracopulmonary compliance.
In this crossover trial, each sequence of four treatment periods, beginning at time of randomization, will last a maximum of 75,5 hours for each patient. The last assessment will occur at a maximum of 76,5 hours from randomisation.
Measured: Hour 76
Lung Reaeration Score at 1 hour from the end of the maneuver
To compare the re-ventilation of the pulmonary territories at one hour of the session (PP or verticalization) evaluated by thoracic ultrasound.
In this crossover trial, each sequence of four treatment periods, beginning at time of randomization, will last a maximum of 75,5 hours for each patient. The last assessment will occur at a maximum of 76,5 hours from randomisation.
Measured: Hour 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start15 Oct 2021
- Primary completion14 Jul 2026 (estimated)
- Study completion14 Jul 2026 (estimated)
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In order to compare the effect of prone position (PP) and verticalization (V) on the PaO2/FiO2 ratio (secondary objective of the study), a randomized cross-over experimental design was chosen. Patients will be randomly assigned to one of the following 4 sequences. They will each include 4 treatment periods: Sequence 1: PP-\>PP-\>V-\>V, Sequence 2: PP-\>V-\>V-\>PP, Sequence 3: V-\>PP-\>PP-\>V Sequence 4: V-\>V-\>PP-\>PP
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mai-ANh NAY, Dr, Principal investigator, CHR Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472260
- Sponsor's protocol ID
- CHRO-2018-12
- Acronym
- STAND_ARDS1
- Status last verified
- Dec 2025
- First submitted
- 25 Jun 2020
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Umbrello M, Formenti P, Bolgiaghi L, Chiumello D. Current Concepts of ARDS: A Narrative Review. Int J Mol Sci. 2016 Dec 29;18(1):64. doi: 10.3390/ijms18010064.
PubMed 28036088
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.
- ClinicalTrials.gov ID
- NCT04472260
- Acronym / sponsor ID
- STAND_ARDS1 / CHRO-2018-12
- Keywords
- Acute respiratory distress syndrome, Verticalization, Intensive Care Unit, Prone position
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 14 Jul 2026 (estimated)
- Study completion
- 14 Jul 2026 (estimated)
- First posted
- 15 Jul 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 according to the Berlin definition (1) as diffuse lung damage occurring in patients with a predisposing risk factor.
Positioning in the prone position (PP) has been shown to decrease mortality in patients with moderate to severe ARDS.
However, this technique is not without deleterious effects such as ventilator-associated pneumonia, endotracheal tube obstruction, development of pressure ulcers, and increased workload for the caregivers.
There are other positioning techniques such as the "upright" position, which simulates a relative verticality, which allows to increase the effects of the prone position and even in some patients to improve oxygenation without the PP in the acute phase of ARDS.
However, given the revolution caused by the use of PP in ARDS patients, verticalization have not been studied in more details.
Today, there is a bed on the market that allows patients to be truly upright without having to transfer them to a tilt table.
The investigators believe that raising ARDS patients in the acute phase is safe and feasible in routine practice. In this research protocol comparing PP and verticalization in a crossover trial design in acute ARDS patients, the investigators want to show that this technique can be safe and feasible, with the same effects on oxygenation as PP.
Detailed description
Cross-over study, according to 4 preset sequences of 4 periods and randomly assigned. All patients will thus have the classic positioning technique (PP), as well as the technique under study (verticalization). For simplicity, the investigators will use the term "verticalization" even if the final positioning that is targeted is only a "pseudo-verticalization" to a 55° angle. The cross-over scheme with 4 sequences of 4 periods allows to get rid of the first order carry-over effect.
Progressive verticalization protocol in 7 steps from the strict supine position to a 55° inclination of the raising bed, according to the clinical responses of the patient with ARDS, as follows:
- Verticalization in the bed
The verticalization maneuver will take place in 7 steps of 15 minutes maximum each:
S1. The first one corresponds to the flat position (strict dorsal decubitus) S2. The second is the positioning of the patient at 25° of inclination. S3. The third is the 45° positioning S4. The fourth at 55°, which corresponds to the greatest inclination imposed to the patient.
S5. The fifth corresponds to the 45° return S6. The sixth is the return to 25° S7. Finally, the investigators reposition the patient flat back.
Examinations:
- Arterial Gazometry At the beginning, at the end and one hour after each positioning technique.
- Chest ultrasound
- Others All adverse events will be recorded in a clear and detailed manner.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- In order to compare the effect of prone position (PP) and verticalization (V) on the PaO2/FiO2 ratio (secondary objective of the study), a randomized cross-over experimental design was chosen. Patients will be randomly assigned to one of the following 4 sequences. They will each include 4 treatment periods: Sequence 1: PP->PP->V->V, Sequence 2: PP->V->V->PP, Sequence 3: V->PP->PP->V Sequence 4: V->V->PP->PP
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: PP->PP->V->V | Other | Procedure: Verticalization and Prone positionThe randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS. The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours. |
| Sequence 2: PP->V->V->PP | Other | Procedure: Verticalization and Prone positionThe randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS. The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours. |
| Sequence 3: V->PP->PP->V | Other | Procedure: Verticalization and Prone positionThe randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS. The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours. |
| Saquence 4: V->V->PP->PP | Other | Procedure: Verticalization and Prone positionThe randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS. The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Major patient > 18 years of age
- ARDS patients with PaO2/FiO2 ratio < 150 at any time within 24 hours prior to the screening visit
- Hemodynamically stable patient with mean arterial pressure (MAP) > 65 mmHg maintained without vasopressor or with norepinephrine at a dosage of less than 0.5 µg/kg/min.
- Patient having already undergone at least 1 but less than 5 PP sessions
- Patient under continuous intravenous sedation (IVSE) or not responding to simple order.
Key exclusion criteria (11 listed)
- Pregnant women (positive pregnancy test during screening)
- Breastfeeding women
- Protected Majors
- Body weight greater than 198 kg (bed load limit)
- Patient with one or two lower limbs amputated at the trans tibial or upper level
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 and Prone positionThe randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS. The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours. | Procedure or surgery | Saquence 4: V->V->PP->PP, Sequence 1: PP->PP->V->V, Sequence 2: PP->V->V->PP, Sequence 3: V->PP->PP->V |
Primary outcome
Percentage of patients who were able to reach 55° of verticalization without serious adverse events (with a complete listing of all adverse events).
Time frame: Month 1
To demonstrate the feasibility and safety in routine practice of the verticalization technique for patients with moderate to severe ARDS in the acute phase.
3 secondary outcomes
PaO2/FiO2 ratio at one hour from the end of the maneuver
Time frame: Hour 76
Quasi-static compliance in (ml/cmH2O) before, at the end and one hour after each positioning technique
Time frame: Hour 76
Lung Reaeration Score at 1 hour from the end of the maneuver
Time frame: Hour 76
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 28036088Umbrello M, Formenti P, Bolgiaghi L, Chiumello D. Current Concepts of ARDS: A Narrative Review. Int J Mol Sci. 2016 Dec 29;18(1):64. doi: 10.3390/ijms18010064.
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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.
Mai-ANh NAY, Dr principal investigator
CHR Orléans
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 and Prone position in people with Acute Respiratory Distress Syndrome and Prone Position, run by Centre Hospitalier Régional d'Orléans 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 30 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurélie DESPUJOLS (+33238744071, aurelie.despujols@chr-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who were able to reach 55° of verticalization without serious adverse events (with a complete listing of all adverse events). (time frame: Month 1). 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 NCT04472260, 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 30 Dec 2025.