Time-controlled Adaptive Ventilation (TCAV) Compared With Conventional Ventilation in Patients With Moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) Secondary to Community-acquired Pneumonia (EARLY-TCAV)
Efficacy and Safety of Time-controlled Adaptive Ventilation (TCAV) Compared With Conventional Ventilation in Patients Requiring Invasive Ventilation for Moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) Secondary to Community-acquired Pneumonia
ARDS is a pathology with mortality rates reaching 40%. Invasive ventilation, the cornerstone of ARDS management, leads to "ventilation-induced lung injury" (VILI). An approach based on pressure-controlled ventilation with unassisted spontaneous respirations (PC-SV or APRV) can limit the occurrence of VILI. Time-controlled adaptive ventilation (TCAV) is based on high mean inspiratory airway pressure, while limiting expiratory time at low pressure. TCAV has shown positive effects in experimental and observational studies. However, its efficacy and safety in patients with moderate-to-severe ARDS remains to be evaluated.
Evaluation of the efficacy of early application of TCAV compared to standard ventilation on the severity of alveolar damage leading to injury-related pulmonary edema in patients with moderate to severe ARDS After obtaining patient's consent, eligible patients will be included in this open-label, randomized controlled pilot study with stratification by minimization based on initial severity. The experimental group will be the TCAV group, where ventilator settings will be standardized. The ventilator in the standard care group will be set to volumetric mode with positive end-expiratory pressure according to the EXPRESS protocol.
The measurement of extravascular lung water will be compared on day 2 between the TCAV settings group and the standard care settings group using the PICCO system.
The TCAV setting is simple and inexpensive. In ARDS patients, the increase in injury-related pulmonary edema is a relevant marker of mortality, and its reduction could improve patients' outcomes. Our study aims to evaluate the efficacy and safety of these settings to justify a future large-scale, multicenter randomized trial.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Matthieu KOSZUTSKI, MD
- Numéro de téléphone: +33 3 83 15 30 17
- E-mail: m.koszutski@chru-nancy.fr
Lieux d'étude
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Nancy, France, 54000
- CHRU de Nancy
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Contact:
- Matthieu KOSZUTSKI, MD
- Numéro de téléphone: +33 3 3 83 15 30 17
- E-mail: m.koszutski@chru-nancy.fr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Intensive care unit hospitalisation for ARDS with a PaO₂/FiO₂ ratio ≤ 200 mmHg and PEEP ≥ 5 cmH₂O under invasive ventilation
- Criteria for community-acquired pneumonia, 2 of the following: cough, purulent sputum, chest pain, dyspnea
- Onset of symptoms ≤ 7 days
- Invasive ventilation initiated ≤ 24 hours
- Affiliation to a social security program
- Patient for whom written consent has been obtained from a trusted person or a family member, or inclusion in a situation of immediate life-threatening emergency
Exclusion Criteria:
- Focal ARDS defined as unilateral involvement (1 out of 4 quadrants or 2 on the same side) on imaging (chest X-ray or CT scan)
- Right heart failure not related to acute pulmonary heart disease secondary to ARDS (pulmonary embolism, myocarditis, ischemic cause)
- Pneumothorax, drained or undrained, with a persistent pleural air leak
- COPD with significant obstructive impairment defined by the presence of chronic respiratory disease and oxygen therapy or non-invasive ventilation at home
- Circulatory support via VV-ECMO or VA-ECMO
- Presence of a patent foramen ovale
- Active limitation of therapies
- Increased intracranial pressure
- Sickle cell disease
- Burns > 30%
- Expected invasive mechanical ventilation for less than 48 hours
- A person covered by Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code
- Pregnant or breastfeeding women
- A not emancipated minor
- Adults subject to legal protective measures (guardianship, conservatorship, judicial protection) or inability to give consent
- Persons deprived of liberty by a judicial or administrative decision, persons receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Time-controlled Adaptative Ventilation
Invasive ventilation with the ventilator set on the Airway Pressure Release Ventilation mode.
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Invasive ventilation with the ventilator set on the Airway Pressure Release Ventilation mode as follows:
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Comparateur actif: Volume Control
Invasive ventilation with the ventilator set on the Volume control mode.
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Invasive ventilation with the ventilator set on the Volume control mode as follows:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Extravascular Lung Water (EVLW)
Délai: 48 hours
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Measured with transpulmonary thermodilution (TPTD) and expressed in ml per kilogram of body weight
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48 hours
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mortality
Délai: 60 days
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Occurrence of death
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60 days
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Ventilator-free days
Délai: day 30
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Number of days without invasive or non-invasive ventilation
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day 30
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Major Adverse Kidney Events (MAKE)
Délai: Day 7, Day 30
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Need of dialysis, decrease ≥ 25% of glomerular filtration rate and all cause-death
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Day 7, Day 30
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Adverse Events
Délai: Day 30
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Defined as:
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Day 30
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Pressure difference
Délai: day 1, day 2, day 3, day 4
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in cmH20
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day 1, day 2, day 3, day 4
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Extravascular Lung Water Indexed to the predicted body weight (EVLWIp)
Délai: 48 hours
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Measured with transpulmonary thermodilution (TPTD) and expressed in ml per kilogram of predicted body weight
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48 hours
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2024PI147
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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