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?

Respiratory Distress Syndrome, Adult Clinical Trial

— OPPRED  

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?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04028336
• Other study ID #: PI2019-01/OPPRED/DRMARC
• Status: Terminated
• Phase: N/A
• Start date: December 20, 2019
• Est. completion date: January 7, 2021

Study information

• Verified date: March 2021
• Source: Centre Hospitalier de Lens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 7, 2021
• Est. primary completion date: January 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Other:
• TITRATION
PEP titration pulmonary opening (PEP-OP) was performed in all patients followed by new LUS and Peso measurement.

Locations

Country	Name	City	State
France	Chu Amiens	Amiens
France	CH Arras	Arras
France	Ch Germon Et Gauthier	Béthune
France	Hospital Dr Schaffner	Lens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Lens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygenation and pulmonary compliance	The primary outcome is oxygenation (PaO2 / FiO2) and pulmonary compliance ((Pplat-Pep) / VT) at 1h of the PEP-OP test.	at 1 hours of the PEP-OP test.
Secondary	Oxygenation (PaO2 / FiO2) at 6h, 12h, 24h	Oxygenation (PaO2 / FiO2) at 6h, 12h, 24h	at 6 hours, 12 hours, 24 hours of the PEP-OP test
Secondary	Mechanical ventilation time	Mechanical ventilation time	Discharge from intensive care unit
Secondary	Hospitalization in intensive care time	Hospitalization in intensive care time	Discharge from intensive care unit
Secondary	The need for recourse to alternative therapies of oxygenation	The need for recourse to alternative therapies of oxygenation	Discharge from intensive care unit
Secondary	Incidence of barotrauma	Incidence of barotrauma	After PEP-OP
Secondary	Pulmonary compliance at 6 hours, 12 hours and 24 hours	Pulmonary compliance at 6 hours, 12 hours and 24 hours	at 6 hours, 12 hours and 24 hours of the PEP-OP test.