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Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety. (STAND_ARDS1)

Primary Purpose

Acute Respiratory Distress Syndrome, Prone Position

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Verticalization and Prone position

About this trial

This is an interventional other trial for Acute Respiratory Distress Syndrome focused on measuring Acute respiratory distress syndrome, Verticalization, Intensive Care Unit, Prone position

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

CHR d'ORLEANSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Arm Label

Sequence 1: PP->PP->V->V

Sequence 2: PP->V->V->PP

Sequence 3: V->PP->PP->V

Saquence 4: V->V->PP->PP

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT04472260

First Posted

June 25, 2020

Last Updated

December 27, 2022

Sponsor

Centre Hospitalier Régional d'Orléans

1. Study Identification

Unique Protocol Identification Number

NCT04472260

Brief Title

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

Acronym

STAND_ARDS1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 15, 2021 (Actual)

Primary Completion Date

October 15, 2023 (Anticipated)

Study Completion Date

October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Distress Syndrome, Prone Position

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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)

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sequence 1: PP->PP->V->V

Arm Type

Other

Arm Description

Arm Title

Sequence 2: PP->V->V->PP

Arm Type

Other

Arm Description

Arm Title

Sequence 3: V->PP->PP->V

Arm Type

Other

Arm Description

Arm Title

Saquence 4: V->V->PP->PP

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Verticalization and Prone position

Intervention Description

Primary Outcome Measure Information:

Title

Percentage of patients who were able to reach 55° of verticalization without serious adverse events (with a complete listing of all adverse events).

Description

To demonstrate the feasibility and safety in routine practice of the verticalization technique for patients with moderate to severe ARDS in the acute phase.

Time Frame

Month 1

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Hour 76

Title

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

Description

Time Frame

Hour 76

Title

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

Description

Time Frame

Hour 76

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aurélie DESPUJOLS

Phone

+33238744071

aurelie.despujols@chr-orleans.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Elodie POUGOUE TOUKO

Phone

+33238744086

elodie.pougoue@chro-orleans.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mai-ANh NAY, Dr

Organizational Affiliation

CHR Orléans

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHR d'ORLEANS

City

Orléans

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aurélie DESPUJOLS

First Name & Middle Initial & Last Name & Degree

May Anh NAY, PH

12. IPD Sharing Statement

Citations:

PubMed Identifier

28036088

Citation

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.

Results Reference

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

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