Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.

NCT04472260 | Recruiting

• 1 other identifier: CHRO-2018-12
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Respiratory Distress Syndrome; Prone Position

Keywords

Acute respiratory distress syndrome; Verticalization; Intensive Care Unit; Prone position

Outcome Measures

Primary Outcomes (1)

• 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.

  Month 1

Secondary Outcomes (3)

• PaO2/FiO2 ratio at one hour from the end of the maneuver

  Hour 76

• Quasi-static compliance in (ml/cmH2O) before, at the end and one hour after each positioning technique

  Hour 76

• Lung Reaeration Score at 1 hour from the end of the maneuver

  Hour 76

Study Arms (4)

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.

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.

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.

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.

Procedure: Verticalization and Prone position

Interventions

Verticalization and Prone position PROCEDURE

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.

Saquence 4: V->V->PP->PP; Sequence 1: PP->PP->V->V; Sequence 2: PP->V->V->PP; Sequence 3: V->PP->PP->V

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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....)
• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHR d'ORLEANS

Orléans, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 28036088 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mai-ANh NAY, Dr

  CHR Orléans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurélie DESPUJOLS

CONTACT

+33238744071; aurelie.despujols@chr-orleans.fr

Elodie POUGOUE TOUKO

CONTACT

+33238744086; elodie.pougoue@chro-orleans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 15, 2020
• Study Start: October 15, 2021
• Primary Completion (Estimated): July 14, 2026
• Study Completion (Estimated): July 14, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

FR (1)