Effect of Prone Positioning on Mortality in Patients With Mild to Moderate Acute Respiratory Distress Syndrome.

NCT ID: NCT05056090

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 656 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-03-01

Brief Summary

Acute respiratory distress syndrome (ARDS) accounts for almost 10% of intensive care units (ICU) admissions. Three ARDS stages have been defined, based on the PaO2/FIO2 ratio measured with positive end-expiratory pressure (PEEP) ≥5 cmH2O: mild (201-300 mmHg), moderate (200-101 mmHg), and severe (≤100mmHg). They represent 30.0%, 46.6%, and 23.4% of ARDS, respectively.

Mechanical invasive ventilation (MV), the cornerstone of ARDS patient care, has a primary goal to protect the lung from ventilator-induced lung injury (VILI). Delivering MV in a prone position (PP) has been shown to improve oxygenation, protect the lung through a better homogenization of lung stress/strain, and stabilize hemodynamics.

A meta-analysis of four randomized controlled trials showed beneficial effect of PP vs. supine position (SP) in the most hypoxemic patients. A fifth randomized controlled trial further showed a significant reduction in mortality with PP in ARDS patients with PaO2/FIO2 <150 mmHg, when neuromuscular blockade and long prone positioning sessions were used. Therefore, PP has since been strongly recommended for ARDS patients with PaO2/FIO2 <150 mmHg. Yet, there is limited evidence in patients with mild to moderate ARDS.

There are, however, strong arguments supporting the need for a new trial in ARDS patients with PaO2/FIO2 in the range 150-300 mmHg:

1. There is no trial that has specifically tested PP in this ARDS subset;

2. PP is safe and has become a standard of care in ICU;

3. Should VILI prevention be a mechanism through which PP improves survival, this should be involved in all ARDS patients;

4. The mortality at hospital discharge in this subset of ARDS remains significant, amounting to 34.9% (95% confidence intervals 31.4-38.5%) in mild and 40.3% (37.4-43.3) in moderate stages;

5. Among 580 patients with mild ARDS at admission to the ICU, in-hospital mortality was 10%, 30%, and 37% for those who improved, persisted, and worsened ARDS, respectively.

6. Finally, PP has been shown to be cost-effective under commonly accepted thresholds.

The hypothesis is that in patients within the 150-300mmHg PaO2/FIO2 range at the time of ARDS diagnosis, PP can reduce mortality as compared to a similar group left in the SP.

Conditions

ARDS; Acute Respiratory Distress Syndrome; Intensive Care Unit; Mechanical Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients will receive MV in PP

Patients assigned to the intervention group will be turned in PP within the two hours after randomization for at least 16 consecutive hours. Then, patients will be turned in SP. Then, PP sessions are repeated as long as stopping criteria for PP are not met

Group Type: EXPERIMENTAL

Patients will receive MV in PP

Intervention Type: PROCEDURE

Putting the patient in a prone position

Patients will receive MV in SP

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patients will receive MV in PP

Putting the patient in a prone position

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age of 18 years or more admitted to ICU.
• ARDS patients meeting the Berlin criteria under invasive mechanical ventilation within the first 24h.
• Mechanically ventilated patients with standard settings: PEEP of 5 cmH2O or more and VT 6 ml/kg PBW and Pplat equal to or below 28-30 cmH2O after intubation.
• PaO2/FIO2 between 150 and 300 mmHg under previous settings within 12 hours after mechanical ventilation standardization.
• Written informed consent obtained from the patient, next of kin/proxy or emergency consent. The patient will be asked to give his consent for the continuation of the trial when his condition will allow.

• Individuals referred to in Articles L. 1121-5 à L. 1121-7 (pregnant women, persons deprived of freedom, minors), adult individuals under protection of law (L. 1121-8 and L. 1122-1-2) (emergency situations) of public health regulation in France
• Patients not affiliated to social security insurance regimen

Exclusion Criteria

• Contra-indication to PP: spine instability; intracranial pressure greater than 20 mmHg; severe facial trauma; hemodynamic instability

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas TERZI

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

Grenoble University Hospital

Grenoble, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Laura CHAMBON

Role: CONTACT

lchambon@chu-grenoble.fr

+33476768955

CRA Sponsor

Role: CONTACT

Arcmoniteur@chu-grenoble.fr

+33476766862

Facility Contacts

Roselyne COLLOMB-MURET

Role: primary

rcollombmuret@chu-grenoble.fr

+33476767109

Pierre NICOLAS

Role: backup

pnicolas@chu-grenoble.fr

+33476767109

Other Identifiers

38RC20.366

Identifier Type: -

Identifier Source: org_study_id