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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Clément Saccheri, MD
- Telefonní číslo: +33 4 92 03 55 10
- E-mail: saccheri.c@chu-nice.fr
Studijní místa
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Nice, Francie
- Chu De Nice
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Kontakt:
- Clément Saccheri, MD
- Telefonní číslo: +33 4 92 03 55 10
- E-mail: saccheri.c@chu-nice.fr
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Vrchní vyšetřovatel:
- Clément Saccheri, MD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Studijní populace
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Level of positive end expiratory pressure
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Minimale driving pressure
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 25-PP-17
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