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NCT Number: NCT07741916

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

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Level of positive end expiratory pressure

    Time frame: at baseline

    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.

Secondary outcomes

  1. Minimale driving pressure

    Time frame: at baseline

    Minimale driving pressure will be assessed at various optimal positive end expiratory pressure levels according with each of the methods used.

    Determining the minimum driving pressure of differents optimal level of positive end expiratory pressure will be determined after the positive end expiratory pressure reduction procedure

  2. Maximum pulmonary compliance

    Time frame: at baseline

    Maximum pulmonary compliance will be assessed at various optimal positive end expiratory pressure levels according with each of the methods used.

    Determining the maximum pulmonary compliance of differents optimal level of positive end expiratory pressure will be determined after the positive end expiratory pressure reduction procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Clément Saccheri, MD

CONTACT

[email protected]

+33 4 92 03 55 10

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Comparison of Different PEEP Strategies in Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS) Based on Various Bedside Assessment Tools

Acronym: OPTI-PEEP

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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