Respiratory failure & ventilation
Temporary Transvenous Diaphragm Neurostimulation for Weaning from Mechanical Ventilation (RESCUE-3)): A Randomized Clinical 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
| Outcome | Adjusted difference (d) (95% CrI) | |
|---|---|---|
| Duration of ventilation to Day 30Posterior probability of superiority, 97.1% | −2.5 (−5.0 to 0.1) | |
| −6−4−202Difference, d (linear scale) |
| Outcome | Treatment | Control | aHR (95% CrI) | |
|---|---|---|---|---|
| Mortality · Day 30Posterior probability of superiority, 80.6% | 9.8% | 10.5% | 0.74 (0.37–1.46) | |
| 0.20.5125Adjusted hazard ratio (log scale) |
- 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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