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出境医 / 临床实验 / 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)

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)

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.

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
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?
Actual Study Start Date : December 20, 2019
Actual Primary Completion Date : January 7, 2021
Actual Study Completion Date : January 7, 2021
Arms and Interventions
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.
Outcome Measures
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 6h, 12h, 24h [ Time Frame: at 6 hours, 12 hours, 24 hours of the PEP-OP test ]
    Oxygenation (PaO2 / FiO2) at 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 6 hours, 12 hours and 24 hours [ Time Frame: at 6 hours, 12 hours and 24 hours of the PEP-OP test. ]
    Pulmonary compliance at 6 hours, 12 hours and 24 hours


Eligibility Criteria
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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 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
Contacts and Locations

Locations
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France
Chu Amiens
Amiens, France, 80054
CH Arras
Arras, France, 62000
Ch Germon Et Gauthier
Béthune, France, 62408
Hospital Dr Schaffner
Lens, France, 62307
Sponsors and Collaborators
Centre Hospitalier de Lens
Investigators
Layout table for investigator information
Principal Investigator: Julien MARC, DR Hospital of Lens
Tracking Information
First Submitted Date  ICMJE July 9, 2019
First Posted Date  ICMJE July 22, 2019
Last Update Posted Date March 4, 2021
Actual Study Start Date  ICMJE December 20, 2019
Actual Primary Completion Date January 7, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2020)
  • Oxygenation (PaO2 / FiO2) at 6h, 12h, 24h [ Time Frame: at 6 hours, 12 hours, 24 hours of the PEP-OP test ]
    Oxygenation (PaO2 / FiO2) at 6h, 12h, 24h
  • Mechanical ventilation time [ Time Frame: Discharge from intensive care unit ]
    Mechanical ventilation time
  • Hospitalization in intensive care time [ Time Frame: Discharge from intensive care unit ]
    Hospitalization in intensive care time
  • 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
  • Incidence of barotrauma [ Time Frame: After PEP-OP ]
    Incidence of barotrauma
  • 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. ]
    Pulmonary compliance at 6 hours, 12 hours and 24 hours
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2019)
  • 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
  • Mechanical ventilation time [ Time Frame: Discharge from intensive care unit ]
    Mechanical ventilation time
  • Hospitalization in intensive care time [ Time Frame: Discharge from intensive care unit ]
    Hospitalization in intensive care time
  • 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
  • Incidence of barotrauma [ Time Frame: After PEP-OP ]
    Incidence of barotrauma
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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?
Official Title  ICMJE 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?
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE Respiratory Distress Syndrome, Adult
Intervention  ICMJE Other: TITRATION
PEP titration pulmonary opening (PEP-OP) was performed in all patients followed by new LUS and Peso measurement.
Study Arms  ICMJE 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.
Intervention: Other: TITRATION
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 2, 2021) 		4
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2019) 		72
Actual Study Completion Date  ICMJE January 7, 2021
Actual Primary Completion Date January 7, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04028336
Other Study ID Numbers  ICMJE PI2019-01/OPPRED/DRMARC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier de Lens
Study Sponsor  ICMJE Centre Hospitalier de Lens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julien MARC, DR Hospital of Lens
PRS Account Centre Hospitalier de Lens
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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