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?

NCT04028336 | Terminated

• 1 other identifier: PI2019-01/OPPRED/DRMARC
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 4

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.

Conditions

Respiratory Distress Syndrome, Adult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Oxygenation (PaO2 / FiO2) at 6h, 12h, 24h

  at 6 hours, 12 hours, 24 hours of the PEP-OP test

• Mechanical ventilation time

  Discharge from intensive care unit

• Hospitalization in intensive care time

  Discharge from intensive care unit

• The need for recourse to alternative therapies of oxygenation

  Discharge from intensive care unit

• Incidence of barotrauma

  After PEP-OP

Study Arms (1)

TITRATION

EXPERIMENTAL

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

Interventions

TITRATION OTHER

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

TITRATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Lens: lead

Study Sites (4)

Chu Amiens

Amiens, 80054, France

Location

CH Arras

Arras, 62000, France

Location

Ch Germon Et Gauthier

Béthune, 62408, France

Location

Hospital Dr Schaffner

Lens, 62307, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Julien MARC, DR

  Hospital of Lens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: July 9, 2019
• First Posted: July 22, 2019
• Study Start: December 20, 2019
• Primary Completion: January 7, 2021
• Study Completion: January 7, 2021
• Last Updated: March 4, 2021

Record last verified: 2021-03

Locations

FR (4)