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Background <p>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 (PaCO<sub>2</sub>). This follow-up study aimed to evaluate whether ULTV impacted long-term pre-specified secondary outcomes in the VT4COVID trial.</p> Methods <p>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 (PaO<sub>2</sub>) over inspired oxygen fraction (FiO<sub>2</sub>) ≤ 150 mmHg, randomized to ULTV with tidal volume (VT) 4 mL.kg<sup>− 1</sup> predicted body weight (PBW), or low VT ventilation (LTV) with VT 6 mL.kg<sup>− 1</sup> 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 <i>a posteriori</i> 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.</p> Results <p>Two hundred and fifteen patients were randomized to ULTV (<i>n</i> = 106) or LTV (<i>n</i> = 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 (CI<sub>95%</sub>):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 [CI<sub>95%</sub>:-4–0] points, <i>p</i> &lt; 0.05). There was no significant difference in SF-36 and IES-R scores between groups. In a <i>post-hoc</i> analysis, MoCA 5-minute score was significantly associated with area under curve (AUC) or maximal PaCO<sub>2</sub> during ARDS management (<i>p</i> &lt; 0.01), but not with AUC or minimal PaO<sub>2</sub>.</p> Conclusions <p>ULTV is associated with a small but significant decrease in cognitive status at day-365 possibly related to exposure to higher PaCO<sub>2</sub>.</p> Trial registration <p>The trial was prospectively registered with ClinicalTrials.gov (NCT04349618) on April 16, 2020.</p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月14日

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  • Jean-Christophe Richard,
  • Fatima Chorfa,
  • Nicolas Terzi,
  • Hodane Yonis,
  • Florent Wallet,
  • Claire Dupuis,
  • Laurent Argaud,
  • Bertrand Delannoy,
  • Guillaume Thiery,
  • Gaël Bourdin,
  • Thomas Rimmele,
  • Michel Muller,
  • Florian Sigaud,
  • Guillaume Rigault,
  • Emilie Joffredo,
  • Mehdi Mezidi,
  • Bertrand Souweine,
  • Loredana Baboi,
  • Hassan Serrier,
  • Muriel Rabilloud,
  • Laurent Bitker

摘要

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.