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?

NCT ID: NCT04028336

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-20
• Study Completion Date: 2021-01-07

Brief Summary

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.

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.

Conditions

Respiratory Distress Syndrome, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TITRATION

Intervention Type: OTHER

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

Interventions

TITRATION

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

Intervention Type: OTHER

Eligibility Criteria

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

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

Sponsors

Centre Hospitalier de Lens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julien MARC, DR

Role: PRINCIPAL_INVESTIGATOR

Hospital of Lens

Locations

Chu Amiens

Amiens, , France

CH Arras

Arras, , France

Ch Germon Et Gauthier

Béthune, , France

Hospital Dr Schaffner

Lens, , France

Countries

France

Other Identifiers

PI2019-01/OPPRED/DRMARC

Identifier Type: -

Identifier Source: org_study_id