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Clinical Trials/NCT04352725
NCT04352725
Unknown
Not Applicable

Effect of Positive End Expiratory Pressure Titration on the End-expiratory Lung Volume Measured by the Nitrogen Dilution Technique in Acute Respiratory Distress Syndrome

Centre Hospitalier Intercommunal Aix-Pertuis1 site in 1 country40 target enrollmentJanuary 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
Centre Hospitalier Intercommunal Aix-Pertuis
Enrollment
40
Locations
1
Primary Endpoint
Observe end-expiratory lung volume change during an increasing PEEP titration procedure in patients with moderate to severe ARDS
Last Updated
6 years ago

Overview

Brief Summary

Mechanical ventilation of the patient with acute respiratory distress syndrome is one of the first therapies.

Detailed Description

The application of positive end expiratory pressure is recommended but the question remains "How to set the best positive end-expiratory pressure (PEEP) level for each patient? ". Different titration techniques have been studied on oxygenation and respiratory mechanics parameters without reaching a consensus. Currently we have a module that is connected to the ventilator to collect the patient's lung volume. It will therefore allow us to optimize the settings of the ventilator and to set the best level of positive end-expiratory pressure "best peep" in order to individualize our treatment for each patient.

Registry
clinicaltrials.gov
Start Date
January 20, 2020
End Date
November 30, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Centre Hospitalier Intercommunal Aix-Pertuis
Responsible Party
Principal Investigator
Principal Investigator

Laurent LEFEBVRE

Doctor, rescuer

Centre Hospitalier Intercommunal Aix-Pertuis

Eligibility Criteria

Inclusion Criteria

  • Patients admitted to intensive care with a diagnosis of moderate to severe ARDS in accordance with the Berlin criteria, i.e. a PAFI \<200 and PEEP \>5cm H20 ratio
  • Diagnosis of ARDS made within 72 hours
  • Age over 18 years
  • Informed consent of the patient and/or trusted person where applicable

Exclusion Criteria

  • Start of mechanical ventilation more than 72 hours prior to inclusion.
  • SDRA evolving for more than 72 hours
  • Presence of major hemodynamic instability with mean blood pressure \<60mmhg, and/or heart rate \<45 bpm or \>150bpm with an increase in vasopressor amine dosage of more than 20% over the last 6 hours.
  • Intracranial hypertension with CPP\<60mmhg
  • Massive hemoptysis requiring immediate surgical or interventional radiology procedure
  • Tracheal surgery (except intensive care tracheotomy) or sternotomy within the previous 15 days
  • Trauma or surgery of the face in the previous 15 days.
  • Deep vein thrombosis treated for less than 2 days
  • Pacemaker implantation in the last 2 days
  • Unstable fracture (spine, femur or pelvis)

Outcomes

Primary Outcomes

Observe end-expiratory lung volume change during an increasing PEEP titration procedure in patients with moderate to severe ARDS

Time Frame: 1 day

Secondary Outcomes

  • Define a threshold of end-expiratory lung volume variation to help determine optimal PEEP(1 day)
  • Analyzing the effect of PEEP titration on static compliance and dynamic strain(1 day)
  • Effect of PEEP titration on hematosis via the calculation of the Pao2/Fio2 ratio for each PEEP step thanks to the measurement of Pao2 on arterial gasometry(1 day)
  • Study the correlation between % change in end-expiratory lung volume and improvement in hematosis (Pao2/Fio2)(1 day)
  • Compare end-expiratory lung volume variations according to the type of ARDS (severity, focal or diffuse, pulmonary or extra-pulmonary etiology)(1 day)
  • Evaluate the hemodynamic tolerance of this procedure with the mean arterial pressure obtained by invasive blood pressure, noradrenaline dosage variation per procedure, lactate (obtained by arterial blood gas)(1 day)

Study Sites (1)

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