The Strategy of "Pulmonary Opening by Titration of Positive End-expiratory Pressure" Means of a Pulmonary Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome: for Which Patients? (OPPRED)

Pulmonary recruitment maneuvers open these lung areas and appropriate adjustment of positive expiratory pressure (PEP) helps to stabilize recruitment and reduce the stress associated with alveolar opening and closing. Its beneficial effects in the lung affected by Acute Respiratory Distress Syndrome (ARDS) remain unclear. The hypothesis is that there is a heterogeneous effect of the recruitment maneuver according to the phenotype of ARDS. It is important to be able to define responder patients from non-responders to this recruiting maneuver.

Study Overview

• Status: Terminated
• Conditions: Respiratory Distress Syndrome, Adult
• Intervention / Treatment: Other: TITRATION

Detailed Description

It will be a prospective interventional study in resuscitation patients with severe or moderate ARDS. This study will be multicentric between the University Hospital of Amiens and intensive care of Lens, intensive care of Bethune and intensive care of Arras. All patients in intensive care and severe, moderate ARDS will be included in this study. All patients will benefit from Lung ultrasound (LUS) with a mapping of each lung looking for normal or pathological lung profiles, as well as a measurement of esophageal pressure (Peso) at rest. A "PEP titration pulmonary opening" (PEP-OP) test using a recruitment maneuver was then performed in all patients followed by a new LUS and Peso measurement.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens
  • Arras, France, 62000
    • CH ARRAS
  • Béthune, France, 62408
    • Ch Germon Et Gauthier
  • Lens, France, 62307
    • Hospital Dr Schaffner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Will be included in the study, patients:

• Major patient (age ≥18 years)
• Controlled assisted ventilation, sedation and curarization adapted to the respirator.
• Within the first 72 hours of an ARDS (PaO2 / FiO2 ≤ 200 mmHg, FiO2 ≥ 60% and PEEP of ≥5 cmH20) (as recommended by the Berlin criteria)
• Decision of intensivist in charge of the patient to put an oesophageal probe
• After hemodynamic optimization (evaluation of the preload dependence and need for catecholamines)
• Decision of the intensivist in charge of the patient to perform a pulmonary opening test by titration of PEEP by means of a pulmonary recruitment test.

Exclusion Criteria:

• Patients under the age of 18
• Pregnant women, women who are parturient or breastfeeding
• Patients with pulmonary broncho-emphysematous pathology or at risk of presenting it.
• Patients with a history of barotrauma or at risk of presenting it.
• Patients with a history of intracranial hypertension
• Patients with suspected or proven right ventricular dysfunction or uncontrolled hemodynamic instability after hemodynamic management.
• Patients with a contraindication to the placement of an oesophageal tube (esophageal surgery, severe esophageal pathology)
• Patients under guardianship or curatorship or deprived of liberty.
• Patients who are legally protected
• Patient not covered by French national health insurance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TITRATION; All patients hospitalized in intensive care and meeting inclusion criteria and without criteria for non-inclusion will be included in this study. All patients will benefit from Lung ultrasound (LUS) and esophageal pressure measurement (Peso) according to the habits of the service. A "PEP titration pulmonary opening" (PEP-OP) test using a recruitment maneuver was then performed in all patients followed by a new LUS and Peso measurement.

Other: TITRATION; PEP titration pulmonary opening (PEP-OP) was performed in all patients followed by new LUS and Peso measurement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygenation and pulmonary compliance	The primary outcome is oxygenation (PaO2 / FiO2) and pulmonary compliance ((Pplat-Pep) / VT) at 1h of the PEP-OP test.	at 1 hours of the PEP-OP test.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation (PaO2 / FiO2) at 6h, 12h, 24h	Oxygenation (PaO2 / FiO2) at 6h, 12h, 24h	at 6 hours, 12 hours, 24 hours of the PEP-OP test
Mechanical ventilation time	Mechanical ventilation time	Discharge from intensive care unit
Hospitalization in intensive care time	Hospitalization in intensive care time	Discharge from intensive care unit
The need for recourse to alternative therapies of oxygenation	The need for recourse to alternative therapies of oxygenation	Discharge from intensive care unit
Incidence of barotrauma	Incidence of barotrauma	After PEP-OP
Pulmonary compliance at 6 hours, 12 hours and 24 hours	Pulmonary compliance at 6 hours, 12 hours and 24 hours	at 6 hours, 12 hours and 24 hours of the PEP-OP test.

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Lens
• Investigators: Principal Investigator: Julien MARC, DR, Hospital of Lens

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2019
• Primary Completion (Actual): January 7, 2021
• Study Completion (Actual): January 7, 2021

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: PI2019-01/OPPRED/DRMARC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No