Academic Journal

Impact of ultra-low tidal volume ventilation on 1-year functional outcome in COVID-19 ARDS patients. A long-term follow-up analysis of a randomized controlled trial.

Λεπτομέρειες βιβλιογραφικής εγγραφής
Τίτλος: Impact of ultra-low tidal volume ventilation on 1-year functional outcome in COVID-19 ARDS patients. A long-term follow-up analysis of a randomized controlled trial.
Συγγραφείς: Richard JC; Medical Intensive Care Unit, Hospices Civils de Lyon, Croix-Rousse Hospital, Lyon, France. j-christophe.richard@chu-lyon.fr.; Université de Lyon, Université Lyon 1, Lyon, France. j-christophe.richard@chu-lyon.fr.; CREATIS INSERM, Villeurbanne, 1044 CNRS 5220, France. j-christophe.richard@chu-lyon.fr., Chorfa F; Service de Biostatistique et Bioinformatique, Hospices Civils de Lyon, Pôle Santé Publique, Lyon, France., Terzi N; Service de Médecine Intensive Réanimation, CHU Grenoble Alpes, La Tronche, France.; Université de Grenoble-Alpes, Grenoble, France.; INSERM U1042, Grenoble, France., Yonis H; Medical Intensive Care Unit, Hospices Civils de Lyon, Croix-Rousse Hospital, Lyon, France., Wallet F; Medical-Surgical Intensive Care Unit, Hospices Civils de Lyon, Lyon-Sud Hospital, Pierre-Bénite, France.; Research on Healthcare Performance RESHAPE, INSERM U1290, Université Claude Bernard Lyon 1, Lyon, France., Dupuis C; Medical Intensive Care Unit, CHU Gabriel Montpied, Clermont- Ferrand, France., Argaud L; Medical Intensive Care Unit, Hospices Civils de Lyon, Edouard Herriot Hospital, Lyon, France., Delannoy B; Medical-Surgical Intensive Care Unit, Clinique de la Sauvegarde, Lyon, France., Thiery G; Research on Healthcare Performance RESHAPE, INSERM U1290, Université Claude Bernard Lyon 1, Lyon, France.; Medical Intensive Care Unit, CHU Saint-Etienne, Hôpital Nord, Saint- Priest-En-Jarez, France., Bourdin G; Medical-Surgical Intensive Care Unit, Centre Hospitalier Saint Joseph-Saint Luc, Lyon, France., Rimmele T; Surgical Intensive Care Unit, Hospices Civils de Lyon, Edouard Herriot Hospital, Lyon, France., Muller M; Medical-Surgical Intensive Care Unit, Centre Hospitalier Annecy Genevois, Pringy, France., Sigaud F; Service de Médecine Intensive Réanimation, CHU Grenoble Alpes, La Tronche, France., Rigault G; Service de Médecine Intensive Réanimation, CHU Grenoble Alpes, La Tronche, France.; Université de Grenoble-Alpes, Grenoble, France., Joffredo E; Medical-Surgical Intensive Care Unit, Hospices Civils de Lyon, Lyon-Sud Hospital, Pierre-Bénite, France., Mezidi M; Medical Intensive Care Unit, Hospices Civils de Lyon, Croix-Rousse Hospital, Lyon, France., Souweine B; Medical Intensive Care Unit, CHU Gabriel Montpied, Clermont- Ferrand, France., Baboi L; Medical Intensive Care Unit, Hospices Civils de Lyon, Croix-Rousse Hospital, Lyon, France., Serrier H; Research on Healthcare Performance RESHAPE, INSERM U1290, Université Claude Bernard Lyon 1, Lyon, France.; Public Health Center, Hospices Civils de Lyon, Health Economic Evaluation Service, Lyon, France., Rabilloud M; Université de Lyon, Université Lyon 1, Lyon, France.; Service de Biostatistique et Bioinformatique, Hospices Civils de Lyon, Pôle Santé Publique, Lyon, France.; Laboratoire de Biométrie et Biologie Évolutive, CNRS, UMR 5558, Équipe Biostatistique-Santé, Villeurbanne, France., Bitker L; Medical Intensive Care Unit, Hospices Civils de Lyon, Croix-Rousse Hospital, Lyon, France.; Université de Lyon, Université Lyon 1, Lyon, France.; CREATIS INSERM, Villeurbanne, 1044 CNRS 5220, France.
Πηγή: Critical care (London, England) [Crit Care] 2026 Jul 14; Vol. 30 (1). Date of Electronic Publication: 2026 Jul 14.
Τύπος έκδοσης: Journal Article; Randomized Controlled Trial; Multicenter Study
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: BioMed Central Ltd Country of Publication: England NLM ID: 9801902 Publication Model: Electronic Cited Medium: Internet ISSN: 1466-609X (Electronic) Linking ISSN: 13648535 NLM ISO Abbreviation: Crit Care Subsets: MEDLINE
Imprint Name(s): Publication: London, UK : BioMed Central Ltd
Original Publication: London : Current Science Ltd, c1997-
Ιατρικοί όροι (MeSH): Tidal Volume*/physiology , COVID-19*/therapy , COVID-19*/complications , Respiratory Distress Syndrome*/therapy , Respiration, Artificial*/methods, Humans ; Female ; Male ; Follow-Up Studies ; Middle Aged ; Aged ; France ; Treatment Outcome ; Intensive Care Units
Περίληψη: Background: Ultra-low tidal volume ventilation (ULTV) aims to minimize ventilator-induced lung injury in acute respiratory distress syndrome (ARDS), but is associated with an increase in arterial carbon dioxide (PaCO2). This follow-up study aimed to evaluate whether ULTV impacted long-term pre-specified secondary outcomes in the VT4COVID trial.
Methods: VT4COVID was an open-label multicenter randomized controlled superiority trial performed in ten French intensive care units. Eligible patients were COVID-19 ARDS patients with arterial oxygen pressure (PaO2) over inspired oxygen fraction (FiO2) ≤ 150 mmHg, randomized to ULTV with tidal volume (VT) 4 mL.kg- 1 predicted body weight (PBW), or low VT ventilation (LTV) with VT 6 mL.kg- 1 PBW. Participants, investigators, and outcome assessors were unblinded to group assignment. The following prespecified secondary outcomes were assessed at day-365: MoCA 5-minute, SF-36 and IES-R scores; mortality at day-365 was added a posteriori as an outcome. Scores were compared between arms with the Mann-Whitney test, and mortality was compared between groups with a Cox proportional-hazard model. All analyses (except mortality at day-365) were conducted according to a modified intention-to-treat principle.
Results: Two hundred and fifteen patients were randomized to ULTV (n = 106) or LTV (n = 109) between April,2020 and April,2021. Seven patients were lost to follow-up and 34 surviving patients had missing data for at least one score. Mortality at day-365 was not significantly different between ULTV and LTV arms (47/102 [46%] vs. 44/106 [42%], hazard ratio 1.19 (95% confidence interval (CI95%):0.79-1.80)). The other secondary outcomes were evaluated in 39/55 [71%] and 44/62 [71%] patients in the ULTV and LTV arm, respectively. The MoCA 5-minute score was significantly lower in the ULTV arm (median difference: -2 [CI95%:-4-0] points, p < 0.05). There was no significant difference in SF-36 and IES-R scores between groups. In a post-hoc analysis, MoCA 5-minute score was significantly associated with area under curve (AUC) or maximal PaCO2 during ARDS management (p < 0.01), but not with AUC or minimal PaO2.
Conclusions: ULTV is associated with a small but significant decrease in cognitive status at day-365 possibly related to exposure to higher PaCO2.
Trial Registration: The trial was prospectively registered with ClinicalTrials.gov (NCT04349618) on April 16, 2020.
(© 2026. The Author(s).)
Competing Interests: Declarations. Ethics approval and consent to participate: The study was conducted in accordance with the amended declaration of Helsinki, and was approved by a research ethics committee (CPP-IDF-VII) on April 14, 2020, under the reference IDCRB-2020-A00869-30. We obtained written informed consent from all patients and/or representatives. Consent for publication: Not applicable. Competing interests: JC Richard received a grant from Hospices Civils de Lyon to conduct the present study, congress attendance fees by Pfizer and Gilead, scientific consultancy fees provided by Gilead unrelated to the submitted work, and lecture fees provided by Astra Zeneca and AMGEN unrelated to the submitted work. F Chorfa did not report any conflict of interest N. Terzi received lecture fees from Pfizer and Fisher & Peykel Healthcare unrelated to the submitted work, and congress attendance fees by Gilead H Yonis received a grant from the French Ministry of Health to conduct the study. F Wallet did not report any conflict of interest C Dupuis did not report any conflict of interest L Argaud did not report any conflict of interest B Delannoy did not report any conflict of interest G Thiery did not report any conflict of interest G Bourdin did not report any conflict of interest T Rimmelé did not report any conflict of interest M Muller did not report any conflict of interest F Sigaud did not report any conflict of interest G Rigaud reported congress attendance fees covered by Pfizer E Joffredo did not report any conflict of interest M Mezidi reported congress attendance fees covered by Pfizer B Souweine did not report any conflict of interest L Baboi did not report any conflict of interest H Serrier did not report any conflict of interest M Rabilloud has no conflict of interest L Bitker received a research grant from Hospices Civils de Lyon to conduct another study, received lecture fees from Viatris, and congress attendance fees from Pfizer. Prior presentation of study results: Part of this work has been presented as an abstract in the following congresses: European society of Intensive Care Medicine 2025 (Munich) Société de Réanimation de Langue Française 2025 (Paris)
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Contributed Indexing: Keywords: ARDS; COVID-19; Cognitive function; Hypercapnia; Protective ventilation.
Molecular Sequence: ClinicalTrials.gov NCT04349618
Entry Date(s): Date Created: 20260715 Date Completed: 20261008 Latest Revision: 20261010
Update Code: 20261010
PubMed Central ID: PMC13647660
DOI: 10.1186/s13054-026-06195-3
PMID: 42449426
Βάση Δεδομένων: MEDLINE