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

Acute Respiratory Distress Syndrome Clinical Trial

— DROP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969407
• Other study ID #: 2018-A01760-55
• Status: Completed
• Start date: November 20, 2018
• Est. completion date: July 20, 2019

Study information

• Verified date: May 2019
• Source: Centre Chirurgical Marie Lannelongue
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 20, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Positive Expiratory Pressure
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Locations

Country	Name	City	State
France	Centre Chirurgical Marie Lannelongue	Le Plessis-Robinson

Sponsors (1)

Lead Sponsor	Collaborator
Centre Chirurgical Marie Lannelongue

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best PEEP level based on the best driving pressure value		1 DAY
Primary	Best PEEP level based on the best oxygenation value defined by the PaO2/FiO2 ratio.		1 DAY