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Temporary Transvenous Diaphragm Neurostimulation for Weaning from Mechanical Ventilation (RESCUE-3).

American journal of respiratory and critical care medicine2025-06-11PubMed
Total: 80.0Innovation: 8Impact: 0Rigor: 0Citation: 0

Summary

In an open-label, multicenter RCT with Bayesian primary analysis, twice-daily transvenous diaphragm neurostimulation increased the probability of 30-day weaning success (HR 1.34; posterior probability 97.9%) and tended to shorten ventilation by 2.5 days. Serious adverse events were more frequent in the treatment group, with no clear mortality difference.

Key Findings

  • 30-day weaning success was higher with neurostimulation (70% vs 61%; adjusted HR 1.34; 95% CrI 1.01–1.78; posterior superiority 97.9%).
  • Ventilation duration to Day 30 was reduced by a mean of 2.5 days (95% CrI −5.0 to 0.1; posterior superiority 97.1%).
  • Serious adverse events occurred more frequently in the treatment group (36% vs 24%); mortality was similar (9.8% vs 10.5%).

Clinical Implications

For patients ventilated ≥96 hours with repeated weaning failures, transvenous diaphragm neurostimulation could be considered as an adjunct to enhance weaning success, but requires careful monitoring given higher serious adverse events and confirmation in larger, blinded trials.

Why It Matters

This is the first international RCT to test transvenous diaphragm neurostimulation for difficult weaning, using a prespecified Bayesian framework and clinically meaningful endpoints.

Limitations

  • Open-label design and early termination may bias estimates and limit statistical power.
  • Higher rate of serious adverse events in the treatment arm requires careful interpretation and mechanistic understanding.

Future Directions

Conduct adequately powered, blinded RCTs to confirm efficacy, refine patient selection, and optimize stimulation protocols while characterizing safety mechanisms.

Study Information

Study Type
RCT
Research Domain
Treatment
Evidence Level
I - Randomized controlled trial with prespecified Bayesian analysis
Study Design
OTHER