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Determination of the Best Positive End-expiratory Pressure (PEEP) (DROP)

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ClinicalTrials.gov Identifier: NCT03969407
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue

Brief Summary:

Determination of the best positive end-expiratory pressure (PEEP) based on oxygenation or driving pressure in patients with acute respiratory distress syndrome (ARDS) after cardiothoracic surgery

The use of a positive end-expiratory pressure in acute respiratory distress syndrome is obvious in ARDS management. On the one hand it serves to fight against the reduction of functional residual capacity (FRC) and enable the limitation of hypoxia; and on the other hand it allows the limitation of "opening/closing" lesions in pulmonary alveoli which lead to increase "bio trauma".

However elevated PEEP has harmful effect such as hemodynamic effect on the right ventricle and distension on healthy part of the lung.Other adverse effects are: decreasing cardiac output, increased risk of barotrauma, and the interference with assessment of hemodynamic pressures.

Ideally the adjustment of PEEP level must be done by taking into account each patient characteristic. PEEP titration based on blood gas analysis is one of the most used techniques by physicians.

Current guidelines for lung-protective ventilation in patients with acute respiratory distress syndrome (ARDS) suggest the use of low tidal volumes (Vt), set according to ideal body weight (IBW) of the patient, and higher levels of positive end-expiratory pressure (PEEP) to limit ventilator-induced lung injury (VILI). However, recent studies have shown that ARDS patients who are ventilated according to these guidelines may still be exposed to forces that can induce or aggravate lung injury.

Driving pressure (DP) is the difference between the airway pressure at the end of inspiration (plateau pressure, Ppl) and PEEP.

Driving pressure may be a valuable tool to set PEEP. Independent of the strategy used to titrate PEEP, changes in PEEP levels should consider the impact on driving pressure, besides other variables such as gas exchange and hemodynamics. A decrease in driving pressure after increasing PEEP will necessarily reflect recruitment and a decrease in cyclic strain. On the contrary, an increase in driving pressure will suggest a non-recruitable lung, in which overdistension prevails over recruitment.

The main purposes of this study are to assess the optimal PEEP based on the best driving pressure or the best oxygenation.


Condition or disease
Positive Expiratory Pressure Acute Respiratory Distress Syndrome

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 118 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Determination of the Best Positive End-expiratory Pressure (PEEP) Based on Oxygenation or Driving Pressure in Patients With Acute Respiratory Distress Syndrome After Cardiac Thoracic Surgery
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : June 20, 2019
Estimated Study Completion Date : July 20, 2019





Primary Outcome Measures :
  1. Best PEEP level based on the best driving pressure value [ Time Frame: 1 DAY ]
  2. Best PEEP level based on the best oxygenation value defined by the PaO2/FiO2 ratio. [ Time Frame: 1 DAY ]


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Ages Eligible for Study:   15 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient admitted to adult intensive care with ARDS following cardiothoracic surgery.
Criteria

Inclusion Criteria:

  • All Patients admitted for intensive care with acute respiratory distress syndrome intubated according to the criteria of the Berlin Consensus

Exclusion Criteria:

  • Undrained pneumothoraces
  • Hemodynamic instability defined by increased need of vasopressors and / or an systolic arterial pressure below 90 mmHg
  • Hypovolemic shock
  • Bronchopleural fistula
  • High intracranial pressure

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): NCT03969407


Contacts
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Contact: François STEPHAN 01.40.94.8580 f.stephan@hml.fr

Locations
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France
Centre Chirurgical Marie Lannelongue Recruiting
Le Plessis-Robinson, France, 92350
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue

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Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT03969407     History of Changes
Other Study ID Numbers: 2018-A01760-55
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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