Ultra-low tidal volume ventilation for COVID-19-related ARDS in France (VT4COVID): a multicentre, open-label, parallel-group, randomised trial

Richard, JC; Terzi, N; Yonis, H; Chorfa, F; Wallet, F; Dupuis, C; Argaud, L; Delannoy, B; Thiery, G; Pommier, C; Abraham, P; Muller, M; Sigaud, F; Rigault, G; Joffredo, E; Mezidi, M; Souweine, B; Baboi, L; Serrier, H; Rabilloud, M; Bitker, L; VT4COVID collaborators

doi:10.1016/s2213-2600(23)00221-7

Respiratory failure & ventilation

Ultra-low tidal volume ventilation for COVID-19-related acute respiratory distress syndrome (ARDS) in France (VT4COVID): a multicentre, open-label, parallel-group, randomised trial

Lancet Respir MedPublished 12 Jul 2023Randomised controlled trial

Primary resultResultUnmatched win ratio 0.85 95% CI 0.60–1.19

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Authors' conclusion

In patients with moderate-to-severe COVID-19-related ARDS, there was no significant difference with ULTV compared with LTV in the composite score based on mortality and ventilator-free days among patients alive at day 60.

Study context

Population: Adults on invasive mechanical ventilation for COVID-19-related ARDS (Berlin definition), PaO2/FiO2 ≤150 mm Hg, VT ≤6.0 mL/kg predicted bodyweight, continuous IV sedation; 10 ICUs in France214 in modified ITT analysis
Participants: 215 adults

Comparison: Ultra-low tidal volume vs low tidal volume
Ultra-low tidal volume (ULTV)n = 106
Low tidal volume (LTV)n = 109reference
Primary endpoint: Ranked composite score:
All-cause mortality at day 90 (first criterion)
Ventilator-free days among patients alive at day 60 (second criterion)
unmatched win ratio

Methodological detailsmulticentre, open-label, parallel-group

Multicentre
Open-label
Parallel-group

Primary result

As reported in the abstract

Unmatched win ratio

0.85

95% CI 0.60–1.19

P = 0.38

ULTV vs LTV

unmatched win ratio 0.85 (95% CI 0.60–1.19); P = 0.38

Further findings

Outcome	ULTV	LTV	← Lower with ULTV ←→ Higher with ULTV →	Absolute difference (CI)	P value
All-cause mortality · day 90	44%	39%	−1001020	4% (−9 to 18)	P = 0.52
			−1001020Difference (linear scale)

Safety

Outcome	ULTV	LTV	← Lower with ULTV ←→ Higher with ULTV →	Absolute difference (95% CI)	P value
Severe respiratory acidosis · first 28 days	33%	13%	−2002040	20% (9–31)	P = 0.0004
			−2002040Difference (linear scale)

Original publication

Ultra-low tidal volume ventilation for COVID-19-related ARDS in France (VT4COVID): a multicentre, open-label, parallel-group, randomised trial. Lancet Respir Med. Published 12 July 2023. doi:10.1016/s2213-2600(23)00221-7

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