Martin Dres, Ralf Ewert, Steven A Conrad, Ali Ataya, Joseph Shrager, Satar Mortaza, Flora Delamaire, Georg Nilius, Alexander Heine, Nawzer Mehta, Judy Ways, Doug Evans, Giorgio Paulon, Farah Khandwala, Nick Berry, Kert Viele, Teresa Nelson, Miranda Gilbertson, Thomas Similowski, Marcelo Gama de Abreu, Ewan C Goligher
{"title":"临时经静脉膈神经刺激脱离机械通气（RESCUE-3）。","authors":"Martin Dres, Ralf Ewert, Steven A Conrad, Ali Ataya, Joseph Shrager, Satar Mortaza, Flora Delamaire, Georg Nilius, Alexander Heine, Nawzer Mehta, Judy Ways, Doug Evans, Giorgio Paulon, Farah Khandwala, Nick Berry, Kert Viele, Teresa Nelson, Miranda Gilbertson, Thomas Similowski, Marcelo Gama de Abreu, Ewan C Goligher","doi":"10.1164/rccm.202505-1056OC","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Diaphragm dysfunction impedes weaning from mechanical ventilation. Transvenous diaphragm neurostimulation can increase diaphragm strength but its impact on patient outcomes is uncertain.</p><p><strong>Methods: </strong>This international, multicenter, open-label, randomized clinical trial (RESCUE-3) included adult patients requiring mechanical ventilation for ≥96 hours who met readiness-to-wean criteria and failed ≥2 weaning attempts. Patients were randomized to twice-daily transvenous diaphragm neurostimulation (Treatment) or standard of care (Control). The primary outcome was successful weaning at Day 30. Secondary outcomes included duration of ventilation to Day 30 and mortality at Day 30. The pre-specified primary analysis utilized a Bayesian approach with borrowing of prior information from a previous phase II randomized trial, downweighted to account for possible differences in trials.</p><p><strong>Results: </strong>Due to slow enrolment and financial considerations, the trial was halted at the first interim analysis after 200 patients were randomized. Overall, 216 patients were randomized in the modified intent-to-treat population (Treatment, 102; Control 114). At Day 30, 71 (70%) Treatment patients and 69 (61%) Control patients were successfully weaned (adjusted hazard ratio 1.34, 95% credible interval 1.01-1.78, posterior probability of superiority, 97.9%). Treatment reduced the duration of ventilation (adjusted difference -2.5 days, 95% credible interval -5.0 to 0.1, posterior probability of superiority, 97.1%). Serious adverse events were reported in 36% of Treatment patients and 24% of Control patients; 9.8% of Treatment patients and 10.5% of Control patients died (adjusted hazard ratio 0.74, 95% credible interval 0.37-1.46, posterior probability of superiority 80.6%).</p><p><strong>Conclusion: </strong>Although the trial was stopped early due to slow enrollment, transvenous diaphragm neurostimulation showed a high probability of potential benefit for weaning success but with a possible increase in serious adverse events. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/). Clinical trial registration available at www.</p><p><strong>Clinicaltrials: </strong>gov, ID: NCT03783884.</p>","PeriodicalId":7664,"journal":{"name":"American journal of respiratory and critical care medicine","volume":" ","pages":""},"PeriodicalIF":19.4000,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Temporary Transvenous Diaphragm Neurostimulation for Weaning from Mechanical Ventilation (RESCUE-3).\",\"authors\":\"Martin Dres, Ralf Ewert, Steven A Conrad, Ali Ataya, Joseph Shrager, Satar Mortaza, Flora Delamaire, Georg Nilius, Alexander Heine, Nawzer Mehta, Judy Ways, Doug Evans, Giorgio Paulon, Farah Khandwala, Nick Berry, Kert Viele, Teresa Nelson, Miranda Gilbertson, Thomas Similowski, Marcelo Gama de Abreu, Ewan C Goligher\",\"doi\":\"10.1164/rccm.202505-1056OC\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Diaphragm dysfunction impedes weaning from mechanical ventilation. Transvenous diaphragm neurostimulation can increase diaphragm strength but its impact on patient outcomes is uncertain.</p><p><strong>Methods: </strong>This international, multicenter, open-label, randomized clinical trial (RESCUE-3) included adult patients requiring mechanical ventilation for ≥96 hours who met readiness-to-wean criteria and failed ≥2 weaning attempts. Patients were randomized to twice-daily transvenous diaphragm neurostimulation (Treatment) or standard of care (Control). The primary outcome was successful weaning at Day 30. Secondary outcomes included duration of ventilation to Day 30 and mortality at Day 30. The pre-specified primary analysis utilized a Bayesian approach with borrowing of prior information from a previous phase II randomized trial, downweighted to account for possible differences in trials.</p><p><strong>Results: </strong>Due to slow enrolment and financial considerations, the trial was halted at the first interim analysis after 200 patients were randomized. Overall, 216 patients were randomized in the modified intent-to-treat population (Treatment, 102; Control 114). At Day 30, 71 (70%) Treatment patients and 69 (61%) Control patients were successfully weaned (adjusted hazard ratio 1.34, 95% credible interval 1.01-1.78, posterior probability of superiority, 97.9%). Treatment reduced the duration of ventilation (adjusted difference -2.5 days, 95% credible interval -5.0 to 0.1, posterior probability of superiority, 97.1%). Serious adverse events were reported in 36% of Treatment patients and 24% of Control patients; 9.8% of Treatment patients and 10.5% of Control patients died (adjusted hazard ratio 0.74, 95% credible interval 0.37-1.46, posterior probability of superiority 80.6%).</p><p><strong>Conclusion: </strong>Although the trial was stopped early due to slow enrollment, transvenous diaphragm neurostimulation showed a high probability of potential benefit for weaning success but with a possible increase in serious adverse events. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/). 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Temporary Transvenous Diaphragm Neurostimulation for Weaning from Mechanical Ventilation (RESCUE-3).
Background: Diaphragm dysfunction impedes weaning from mechanical ventilation. Transvenous diaphragm neurostimulation can increase diaphragm strength but its impact on patient outcomes is uncertain.
Methods: This international, multicenter, open-label, randomized clinical trial (RESCUE-3) included adult patients requiring mechanical ventilation for ≥96 hours who met readiness-to-wean criteria and failed ≥2 weaning attempts. Patients were randomized to twice-daily transvenous diaphragm neurostimulation (Treatment) or standard of care (Control). The primary outcome was successful weaning at Day 30. Secondary outcomes included duration of ventilation to Day 30 and mortality at Day 30. The pre-specified primary analysis utilized a Bayesian approach with borrowing of prior information from a previous phase II randomized trial, downweighted to account for possible differences in trials.
Results: Due to slow enrolment and financial considerations, the trial was halted at the first interim analysis after 200 patients were randomized. Overall, 216 patients were randomized in the modified intent-to-treat population (Treatment, 102; Control 114). At Day 30, 71 (70%) Treatment patients and 69 (61%) Control patients were successfully weaned (adjusted hazard ratio 1.34, 95% credible interval 1.01-1.78, posterior probability of superiority, 97.9%). Treatment reduced the duration of ventilation (adjusted difference -2.5 days, 95% credible interval -5.0 to 0.1, posterior probability of superiority, 97.1%). Serious adverse events were reported in 36% of Treatment patients and 24% of Control patients; 9.8% of Treatment patients and 10.5% of Control patients died (adjusted hazard ratio 0.74, 95% credible interval 0.37-1.46, posterior probability of superiority 80.6%).
Conclusion: Although the trial was stopped early due to slow enrollment, transvenous diaphragm neurostimulation showed a high probability of potential benefit for weaning success but with a possible increase in serious adverse events. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/). Clinical trial registration available at www.
期刊介绍：
The American Journal of Respiratory and Critical Care Medicine focuses on human biology and disease, as well as animal studies that contribute to the understanding of pathophysiology and treatment of diseases that affect the respiratory system and critically ill patients. Papers that are solely or predominantly based in cell and molecular biology are published in the companion journal, the American Journal of Respiratory Cell and Molecular Biology. The Journal also seeks to publish clinical trials and outstanding review articles on areas of interest in several forms. The State-of-the-Art review is a treatise usually covering a broad field that brings bench research to the bedside. Shorter reviews are published as Critical Care Perspectives or Pulmonary Perspectives. These are generally focused on a more limited area and advance a concerted opinion about care for a specific process. Concise Clinical Reviews provide an evidence-based synthesis of the literature pertaining to topics of fundamental importance to the practice of pulmonary, critical care, and sleep medicine. Images providing advances or unusual contributions to the field are published as Images in Pulmonary, Critical Care, Sleep Medicine and the Sciences.
A recent trend and future direction of the Journal has been to include debates of a topical nature on issues of importance in pulmonary and critical care medicine and to the membership of the American Thoracic Society. Other recent changes have included encompassing works from the field of critical care medicine and the extension of the editorial governing of journal policy to colleagues outside of the United States of America. The focus and direction of the Journal is to establish an international forum for state-of-the-art respiratory and critical care medicine.
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