Physiological Study of Prone Position in Acute Respiratory Failure Syndrome

NCT06061796 | Unknown

• 1 other identifier: APHP230672
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

ARDS is an acutely induced respiratory failure characterized by the appearance of bilateral alveolar opacities on imaging and hypoxemia Etiologies are divided into two classes: pulmonary, including all infectious pathologies, aspiration pneumonia, and drowning, and extra-pulmonary, induced by sepsis or acute pancreatitis. The mortality rate of ARDS remains high in unselected patient populations Among strategies that have proven beneficial in terms of patient outcome, prone positioning (PP) is associated with the greatest impact in terms of reduction in mortality. PP is currently recommended in the European guidelines for ARDS associated with a PaO2/FiO2 ratio \< 150 mmHg in patients in whom ventilatory settings have been optimized beforehand, The failure of early PP studies to demonstrate a survival benefit in ARDS was attributed to insufficient session duration. The PROSEVA study was the first to demonstrate that a PP duration of 17 h is associated with a reduction in mortality During the COVID-19 pandemic, several centers have reported the implementation of longer PP sessions. Two strategies have emerged from these studies. In one case, the patient was left in the prone position until the criteria for stopping PP were met. Thus, the PP/supine position alternation was completely suppressed. In another published strategy, PP sessions were maintained for a period covering two nights. Furthermore, in a multicenter retrospective study, PP sessions were maintained until clinical improvement was associated with reduced mortality. In this study of 263 patients, the median duration of PP in the extended duration group was 40 h, and 75% of the sessions lasted 48 h or less. Using a propensity score, the authors showed that patients treated with an extended PP duration had a lower 3-month mortality rate than patients in the standard duration group . This protocol was also associated with a 29% cumulative incidence of pressure sores, similar to the 25% cumulative incidence reported in the PROSEVA study Other data published on pressure sores and PP of duration \> 24 hours are also reassuring. Finally, a recent review recently reported that an extended PP session of \> 24 h had also been used before the COVID-19 pandemic. PP sessions had a median duration of 47-78 hours and were applied mainly to ARDS secondary to community-acquired pneumonia. All pre-COVID studies were retrospective, monocentric, without a control group.

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS; Prone position; P/F ratio; ventilation distribution

Outcome Measures

Primary Outcomes (1)

• Distribution of intra-pulmonary ventilation volumes during PP sessions maintained until clinical improvement and for a maximum of 48 hours.

  The primary endpoint is the center of lung ventilation measured by the EIT between H+16 and before return in the supine position. This index approximates the proportion of ventilation attributable to the dorsal pulmonary units. It is calculated as follows: CVP(%)= ((ΔZ at the level of dorsal pulmonary units)\*100)/(ΔZ in the whole lung) Where CVP means the center of alveolar ventilation and ΔZ means the variation in electrical impedance during the ventilatory cycle.

  EITmeasurements between H+16 and before return in the supine position

Secondary Outcomes (5)

• Evaluation during a PP session maintained until clinical improvement and for a maximum of 48 of the percentage, of the percentage of over-distended pulmonary units

  EITmeasurements between H+16 and before return in the supine position

• Evaluation during a PP session maintained until clinical improvement and for a maximum of 48 of the percentage of pulmonary units opening and closing with each respiratory cycle

  EITmeasruements between H+16 and before return in the supine position

• Evaluation during a PP session maintained until clinical improvement and for a maximum of 48 of the percentage of collapsed pulmonary units

  EIT measurements between H+16 and before return in the supine position

• Evaluation during a PP session maintained until clinical improvement and for a maximum of 48 of percentage of recruitable pulmonary units

  EIT measurements between H+16 and before return in the supine position

• Evaluation of the association between prolonged PP duration and the incidence of pressure sores

  The last day in ICU

Study Arms (1)

prone position extended

EXPERIMENTAL

prone position extended all patients included

Procedure: prone position

Interventions

prone position PROCEDURE

patient kept in prone position until the following criteria have been reach for 4 consecutive hours: * ratio P/F \> 150 mm Hg * FiO2 \< 60% * PEEP ≤ 10 cm d'H2O

prone position extended

Eligibility Criteria

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

You may qualify if:

• patient with with ARDS with a P/F ratio \< 150 mm Hg regardless of etiology
• invasive ventilated patient
• indication for DV placement determined by the treating practitioner
• BMI≥ 18 kg/m²
• Affiliated to social security

You may not qualify if:

• Patients who have already undergone two prone position sessions
• Pregnant women
• Refusal to participate in the research
• Patients under guardianship and trusteeship
• Patients under State Medical Assistance (AME)
• Uncontrolled intracranial hypertension
• Unstable spinal fracture
• Hemodynamic instability defined by MAP \< 65 mmHg
• Presence of a pacemaker
• Presence of an implantable defibrillator
• Unresolved pneumothorax or bronchopleural fistula

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Louis Mourier Hospital

Colombes, 92700, France

RECRUITING

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

• Jean Damien Ricard, MD/PHD

  Louis Mourier (AP-HP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Damien Ricard, MD/PHD

CONTACT

01 47 60 61 62; jean-damien.ricard@aphp.fr

thais Walter

CONTACT

thais.walter@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patient in pp (maximum 48h) until the following criteria are reached for 4 consecutive hours: * P/F ratio \> 150 mm Hg * FiO2 \< 60% * Positive End-Exhalation Pressure (PEEP)

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 29, 2023
• Study Start: November 18, 2024
• Primary Completion: January 18, 2025
• Study Completion: May 18, 2025
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)