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

28. juli 2026 opdateret af: Centre Hospitalier Universitaire de Nice

Comparison of Different PEEP Strategies in Moderate-to-Severe Acute Respiratory Distress Syndrome (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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

45

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Nice, Frankrig
        • Chu De Nice
        • Kontakt:
        • Ledende efterforsker:
          • Clément Saccheri, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Patients on invasive mechanical ventilation

  • With moderate-to-severe ARDS :

    1. Bilateral findings on chest X-ray
    2. PaO₂/FiO₂ ratio <200 with PEEP ≥+5 cmH₂O
    3. 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:

    1. Individuals receiving enhanced protection, namely minors
    2. Individuals deprived of their liberty by a judicial or administrative decision
    3. Pregnant and breastfeeding women
    4. Individuals residing in a health or social care facility
    5. 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

    1. An increase of >30% in the norepinephrine dosage over the past 6 hours
    2. Norepinephrine dosage > 0.5 µg/kg/min
  • Patients on veno-venous ECMO

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Studiepopulation
Kosttilskud: Ventilation at different levels of PEP including a test involving a gradual decrease in PEP.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Level of positive end expiratory pressure
Tidsramme: 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.
at baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Minimale driving pressure
Tidsramme: 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
at baseline
Maximum pulmonary compliance
Tidsramme: 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
at baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire de Nice

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. september 2029

Studieafslutning (Anslået)

1. januar 2030

Datoer for studieregistrering

Først indsendt

23. juli 2026

Først indsendt, der opfyldte QC-kriterier

28. juli 2026

Først opslået (Faktiske)

3. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25-PP-17

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