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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?

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?

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04028336
Acronym
OPPRED
Enrollment
4
Registered
2019-07-22
Start date
2019-12-20
Completion date
2021-01-07
Last updated
2021-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Adult

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.

Interventions

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

Sponsors

Centre Hospitalier de Lens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
oxygenation and pulmonary complianceat 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

MeasureTime frameDescription
Mechanical ventilation timeDischarge from intensive care unitMechanical ventilation time
Hospitalization in intensive care timeDischarge from intensive care unitHospitalization in intensive care time
Oxygenation (PaO2 / FiO2) at 6h, 12h, 24hat 6 hours, 12 hours, 24 hours of the PEP-OP testOxygenation (PaO2 / FiO2) at 6h, 12h, 24h
Incidence of barotraumaAfter PEP-OPIncidence of barotrauma
Pulmonary compliance at 6 hours, 12 hours and 24 hoursat 6 hours, 12 hours and 24 hours of the PEP-OP test.Pulmonary compliance at 6 hours, 12 hours and 24 hours
The need for recourse to alternative therapies of oxygenationDischarge from intensive care unitThe need for recourse to alternative therapies of oxygenation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026