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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome; Positive Expiratory Pressure

• Study Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

Study Locations

• France
  • Le Plessis-Robinson, France, 92350
    • Centre Chirurgical Marie Lannelongue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient admitted to adult intensive care with ARDS following cardiothoracic surgery.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Best PEEP level based on the best driving pressure value	1 DAY
Best PEEP level based on the best oxygenation value defined by the PaO2/FiO2 ratio.	1 DAY

Collaborators and Investigators

• Sponsor: Centre Chirurgical Marie Lannelongue

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Actual): June 20, 2019
• Study Completion (Actual): July 20, 2019

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 2018-A01760-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No