Clinical trial NCT04028336: 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?
Official title: 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?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Distress Syndrome, Adult
Lead sponsor: Centre Hospitalier de Lens
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: oxygenation and pulmonary compliance
timeFrame: at 1 hours of the PEP-OP test.
Secondary outcomes:
measure: Oxygenation (PaO2 / FiO2) at 6h, 12h, 24h
timeFrame: at 6 hours, 12 hours, 24 hours of the PEP-OP test
measure: Mechanical ventilation time
timeFrame: Discharge from intensive care unit
measure: Hospitalization in intensive care time
timeFrame: Discharge from intensive care unit
measure: The need for recourse to alternative therapies of oxygenation
timeFrame: Discharge from intensive care unit
measure: Incidence of barotrauma
timeFrame: After PEP-OP
measure: Pulmonary compliance at 6 hours, 12 hours and 24 hours
timeFrame: at 6 hours, 12 hours and 24 hours of the PEP-OP test.
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
city: Arras
country: France
facility: CH Arras
city: Béthune
country: France
facility: Ch Germon Et Gauthier
city: Lens
country: France
facility: Hospital Dr Schaffner
Study officials:
affiliation: Hospital of Lens
name: Julien MARC, DR
role: PRINCIPAL_INVESTIGATOR
References: