Comparison of Different PEEP Strategies in Moderate-to-Severe ARDS Based on Various Bedside Assessment Tools

NCT07741916 | Not Yet Recruiting

• 1 other identifier: 25-PP-17
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Many patients admitted to the intensive care unit (ICU) for a severe lung disease called acute respiratory distress syndrome (ARDS) require mechanical ventilation and positive end-expiratory pressure (PEEP) to improve their oxygenation. Ventilator settings-and particularly the level of PEEP-are critical in the management of these patients. In fact, inappropriate ventilator settings can lead to a worsening of the patients' lung disease or compromise their hemodynamic status. PEEP is a pressure maintained by the ventilator during the patient's exhalation to keep the alveoli open throughout the respiratory cycle. When PEEP is increased, if many alveoli open, this is called alveolar recruitment, which is the expected beneficial effect. However, in some patients, increasing PEEP can cause already-open alveoli to become overdistended without opening new alveoli; this is known as pulmonary overdistension. This phenomenon of overdistension will worsen the patient's pulmonary condition and may also lead to hemodynamic deterioration. To date, numerous techniques have been proposed for determining the optimal PEP level (alveolar recruitment without pulmonary overdistension) in these patients, but none can be recommended as the gold standard. The objective of our study is therefore to compare the various existing methods for determining the optimal PEEP level, in order to determine whether these methods are interchangeable and which would be the best method to use to optimize the care of these patients. To this end, the investigators plan to conduct a prospective, observational, multicenter study in the Intensive Care Units of the Nice University Hospital and the European Hospital of Marseille. Patients on mechanical ventilation for ARDS will be included in the study, and medical and laboratory data from the electronic medical records obtained during the various PEEP measurements to determine the optimal PEEP will be analyzed.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress Syndrome; positive end expiratory pression

Outcome Measures

Primary Outcomes (1)

• Level of positive end expiratory pressure

  The primary outcome measure will be the optimal level of positive end expiratory pressure achieved with each of the methods used. The measurement of differents optimal level of positive end expiratory pressure will be determined after the positive end expiratory pressure reduction procedure.

  at baseline

Secondary Outcomes (2)

• Minimale driving pressure

  at baseline

• Maximum pulmonary compliance

  at baseline

Study Arms (1)

Study population

EXPERIMENTAL

Dietary Supplement: Ventilation at different levels of PEP including a test involving a gradual decrease in PEP.

Interventions

Ventilation at different levels of PEP including a test involving a gradual decrease in PEP. DIETARY_SUPPLEMENT

Initial PEEP level will be set according to the PEEP/FiO2 table. The PEEP level will then be adjusted to achieve a plateau pressure of 28-30 cmH₂O. After 10 minutes, various hemodynamic and respiratory variables will be recorded, and an arterial blood gas analysis will be performed to assess the patient's respiratory mechanics and oxygenation. Next, the airway opening pressure will be measured, and the patient's recruitment potential will be assessed by calculating the R/I ratio through a sudden reduction in PEP from 15 cmH₂O to 5 cmH₂O over a single respiratory cycle. Following this, PEEP will be raised back to the initial level for at least 5 minutes and then gradually reduced in 2 cmH₂O increments every 2 minutes until reaching the AOP level or a PEEP level of 5 cmH₂O. In total, the optimal PEP level will be determined using six different techniques, allowing the clinician to obtain six optimal PEP values and thus best customize the ventilator settings for each patient.

Study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients on invasive mechanical ventilation
• With moderate-to-severe ARDS :
• Bilateral findings on chest X-ray
• PaO₂/FiO₂ ratio \<200 with PEEP ≥+5 cmH₂O
• No evidence of cardiogenic pulmonary overload
• Patients without inspiratory effort (curare administration not required)
• Patient already fitted with an esophageal pressure probe
• Patient already fitted with a thoracic impedance belt
• No objection from the patient or a family member to the processing of their clinical data

You may not qualify if:

• Protected individuals, namely:
• Individuals receiving enhanced protection, namely minors
• Individuals deprived of their liberty by a judicial or administrative decision
• Pregnant and breastfeeding women
• Individuals residing in a health or social care facility
• Adults under legal guardianship
• Patients with a do-not-resuscitate order or a decision to limit care
• Patients with a pacemaker or an implantable cardioverter-defibrillator
• Acute cor pulmonale
• Pneumothorax or ongoing pleural/thoracic drainage
• Patients in the prone position
• Hemodynamic instability
• An increase of \>30% in the norepinephrine dosage over the past 6 hours
• Norepinephrine dosage \> 0.5 µg/kg/min
• Patients on veno-venous ECMO

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Clément Saccheri, MD

CONTACT

+33 4 92 03 55 10; saccheri.c@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

FR (1)