Respiratory failure & ventilation

Temporary Transvenous Diaphragm Neurostimulation for Weaning from Mechanical Ventilation (RESCUE-3)): A Randomized Clinical Trial

Am J Respir Crit Care MedPublished Randomised controlled trial

Primary result · Successful weaningResult — go to the resultAdjusted hazard ratio 1.34 95% CrI 1.01–1.78
  • stopped early at first interim analysis

Authors' conclusion

Although the trial was stopped early because of slow enrollment, transvenous diaphragm neurostimulation showed a high probability of potential benefit for weaning success but with a possible increase in serious adverse events.

Study context

Population
Adults mechanically ventilated ⩾96 hours, meeting readiness-to-wean criteria, who failed two or more weaning attemptsmodified ITT population
Participants
216 participants
Comparison
Twice-daily transvenous diaphragm neurostimulation vs standard of care
  • Treatmentn = 102
  • Controln = 114reference
Primary endpoint
Successful weaning
Follow-up
Day 30
Methodological detailsinternational, multicentre, open-label, Bayesian primary analysis with borrowing from a previous Phase-II RCT, Halted at the first interim analysis after 200 patients randomized because of slow enrollment
  • International
  • Multicentre
  • Open-label
  • Bayesian primary analysis with borrowing from a previous Phase-II RCT
  • Halted at the first interim analysis after 200 patients randomized because of slow enrollment

Primary result

As reported in the abstract

Adjusted hazard ratio

1.34

95% CrI 1.01–1.78

Events by treatment group

Treatment vs Control
aHR 1.34 (95% CrI 1.01–1.78)

Secondary outcomes

OutcomeAdjusted difference (d) (95% CrI)
Duration of ventilation to Day 30Posterior probability of superiority, 97.1%−2.5 (−5.0 to 0.1)
OutcomeTreatmentControlaHR (95% CrI)
Mortality · Day 30Posterior probability of superiority, 80.6%9.8%10.5%0.74 (0.37–1.46)
  • Duration of ventilation to Day 30: 95% CrI
  • Mortality: 95% CrI

Safety

Serious adverse events

Original publication

Temporary Transvenous Diaphragm Neurostimulation for Weaning from Mechanical Ventilation (RESCUE-3)): A Randomized Clinical Trial. Am J Respir Crit Care Med. Published 11 June 2025. doi:10.1164/rccm.202505-1056oc

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