Comparison of Different PEEP Strategies in Moderate-to-Severe ARDS Based on Various Bedside Assessment Tools (OPTI-PEEP)
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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Clément Saccheri, MD
- Telefoonnummer: +33 4 92 03 55 10
- E-mail: saccheri.c@chu-nice.fr
Studie Locaties
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Nice, Frankrijk
- Chu De Nice
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Contact:
- Clément Saccheri, MD
- Telefoonnummer: +33 4 92 03 55 10
- E-mail: saccheri.c@chu-nice.fr
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Hoofdonderzoeker:
- Clément Saccheri, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Studie bevolking
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Level of positive end expiratory pressure
Tijdsspanne: at baseline
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Minimale driving pressure
Tijdsspanne: at baseline
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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
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Maximum pulmonary compliance
Tijdsspanne: at baseline
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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
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 25-PP-17
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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