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Trial record 22 of 198 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

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)

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ClinicalTrials.gov Identifier: NCT04028336
Recruitment Status : Not yet recruiting
First Posted : July 22, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Other: TITRATION Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
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?
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : July 25, 2020
Estimated Study Completion Date : July 25, 2020


Arm Intervention/treatment
Experimental: 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.
Other: TITRATION
PEP titration pulmonary opening (PEP-OP) was performed in all patients followed by new LUS and Peso measurement.




Primary Outcome Measures :
  1. oxygenation and pulmonary compliance [ Time Frame: 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 :
  1. Oxygenation (PaO2 / FiO2) at 3h, 6h, 12h, 24h [ Time Frame: at 3 hours, 6 hours, 12 hours, 24 hours of the PEP-OP test ]
    Oxygenation (PaO2 / FiO2) at 3h, 6h, 12h, 24h

  2. Mechanical ventilation time [ Time Frame: Discharge from intensive care unit ]
    Mechanical ventilation time

  3. Hospitalization in intensive care time [ Time Frame: Discharge from intensive care unit ]
    Hospitalization in intensive care time

  4. The need for recourse to alternative therapies of oxygenation [ Time Frame: Discharge from intensive care unit ]
    The need for recourse to alternative therapies of oxygenation

  5. Incidence of barotrauma [ Time Frame: After PEP-OP ]
    Incidence of barotrauma

  6. Pulmonary compliance at 3 hours, 6 hours, 12 hours and 24 hours [ Time Frame: at 3 hours, 6 hours, 12 hours and 24 hours of the PEP-OP test. ]
    Pulmonary compliance at 3 hours, 6 hours, 12 hours and 24 hours



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, FiO2 ≥ 60mmHg 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028336


Contacts
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Contact: Julien MARC, DR 03.21.69.23.46 jmarc@ch-lens.fr
Contact: Mélanie VERLAY 03.21.69.10.28 mverlay@ch-lens.fr

Locations
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France
Hospital Dr Schaffner Not yet recruiting
Lens, France, 62307
Contact: MELANIE VERLAY    03.21.69.10.28    mverlay@ch-lens.fr   
Principal Investigator: JULIEN MARC, Dr         
Sponsors and Collaborators
Centre Hospitalier de Lens
Investigators
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Principal Investigator: Julien MARC, DR Hospital of Lens

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Responsible Party: Centre Hospitalier de Lens
ClinicalTrials.gov Identifier: NCT04028336     History of Changes
Other Study ID Numbers: PI2019-01/OPPRED/DRMARC
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury