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?

Not Applicable

Terminated

• Conditions: Respiratory Distress Syndrome, Adult
• Interventions: Other: TITRATION

• Registration Number: NCT04028336
• Lead Sponsor: Centre Hospitalier de Lens

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.

Study Timeline

• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-19
• Study First Posted: 2019-07-22
• Study Start: 2019-12-20
• Primary Completion: 2021-01-07
• Study Completion: 2021-01-07
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TITRATION	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Ch Germon Et Gauthier; 🇫🇷 Béthune, France

CH Arras; 🇫🇷 Arras, France

Chu Amiens; 🇫🇷 Amiens, France

Hospital Dr Schaffner; 🇫🇷 Lens, France