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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? (OPPRED)

Primary Purpose

Respiratory Distress Syndrome, Adult

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TITRATION
Sponsored by
Centre Hospitalier de Lens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Respiratory Distress Syndrome, Adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Amiens
  • CH Arras
  • Ch Germon Et Gauthier
  • Hospital Dr Schaffner

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TITRATION

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Oxygenation (PaO2 / FiO2) at 6h, 12h, 24h
Oxygenation (PaO2 / FiO2) at 6h, 12h, 24h
Mechanical ventilation time
Mechanical ventilation time
Hospitalization in intensive care time
Hospitalization in intensive care time
The need for recourse to alternative therapies of oxygenation
The need for recourse to alternative therapies of oxygenation
Incidence of barotrauma
Incidence of barotrauma
Pulmonary compliance at 6 hours, 12 hours and 24 hours
Pulmonary compliance at 6 hours, 12 hours and 24 hours

Full Information

First Posted
July 9, 2019
Last Updated
March 2, 2021
Sponsor
Centre Hospitalier de Lens
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1. Study Identification

Unique Protocol Identification Number
NCT04028336
Brief 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?
Acronym
OPPRED
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Technical difficulties
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
January 7, 2021 (Actual)
Study Completion Date
January 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier de Lens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Adult

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TITRATION
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
TITRATION
Intervention Description
PEP titration pulmonary opening (PEP-OP) was performed in all patients followed by new LUS and Peso measurement.
Primary Outcome Measure Information:
Title
oxygenation and pulmonary compliance
Description
The primary outcome is oxygenation (PaO2 / FiO2) and pulmonary compliance ((Pplat-Pep) / VT) at 1h of the PEP-OP test.
Time Frame
at 1 hours of the PEP-OP test.
Secondary Outcome Measure Information:
Title
Oxygenation (PaO2 / FiO2) at 6h, 12h, 24h
Description
Oxygenation (PaO2 / FiO2) at 6h, 12h, 24h
Time Frame
at 6 hours, 12 hours, 24 hours of the PEP-OP test
Title
Mechanical ventilation time
Description
Mechanical ventilation time
Time Frame
Discharge from intensive care unit
Title
Hospitalization in intensive care time
Description
Hospitalization in intensive care time
Time Frame
Discharge from intensive care unit
Title
The need for recourse to alternative therapies of oxygenation
Description
The need for recourse to alternative therapies of oxygenation
Time Frame
Discharge from intensive care unit
Title
Incidence of barotrauma
Description
Incidence of barotrauma
Time Frame
After PEP-OP
Title
Pulmonary compliance at 6 hours, 12 hours and 24 hours
Description
Pulmonary compliance at 6 hours, 12 hours and 24 hours
Time Frame
at 6 hours, 12 hours and 24 hours of the PEP-OP test.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien MARC, DR
Organizational Affiliation
Hospital of Lens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CH Arras
City
Arras
ZIP/Postal Code
62000
Country
France
Facility Name
Ch Germon Et Gauthier
City
Béthune
ZIP/Postal Code
62408
Country
France
Facility Name
Hospital Dr Schaffner
City
Lens
ZIP/Postal Code
62307
Country
France

12. IPD Sharing Statement

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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?

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