Multi-center randomized superiority clinical trial in the early phase of mechanically ventilated patients to preserve diaphragm thickness using non-invasive magnetic phrenic nerve stimulation: STIMIT ACTIVATOR 1 pivotal trial
Por:
Schreiber, AF, Subirà, C, Sklar, M, Santos, M, Ko, M, Panelli, A, Schaller, SJ, Theodore, D, Rowley, DD, Watson, D, Bonde, P, Kassis, ENB, Talmor, DS, Ranieri, M, Goligher, EC, Slutsky, A, Brochard, LJ
Publicada:
11 jun 2025
Resumen:
Background Ventilator-induced diaphragmatic dysfunction (VIDD) occurs in up to 60% of mechanically ventilated patients and prolongs ventilatory dependance. The consequences of VIDD are muscle atrophy, reduction of strength, and injury of muscle fibers. Atrophy and contractile activity of the diaphragm can be estimated by ultrasound muscle thickness and thickening fraction. Prior experience demonstrates invasive electrical stimulation of the diaphragm helps preserve muscle thickness. This is the first study on a non-invasive phrenic nerve stimulator that aims to assess its feasibility, safety, and usefulness in preserving diaphragm thickness. Methods A multi-center randomized clinical trial will be performed in four intensive care units (ICUs) in the United States of America and Canada. Inclusion criteria include patients older than 21 years, in the first 48 h of mechanical ventilation (MV) and predicted to remain on the ventilator for at least 48 h. Patients with contraindications for phrenic nerve stimulation, severe chronic pulmonary diseases, or impossibility to measure diaphragm thickness with ultrasound will be excluded. Patients enrolled will be randomized to standard care (control) or 30-min daily non-invasive phrenic nerve stimulation up to 10 days after enrollment (intervention). The primary effectiveness endpoint is the change in diaphragm thickness on day 10, extubation, or death whichever occurs first. Secondary endpoints include change in diaphragm thickness on day 4, maximal inspiratory pressure before extubation, and time-to rapid shallow breathing index (RSBI) <105. Safety objectives include the proportion of device- or procedure-related adverse events (SAE). The estimated sample size will be 40 patients (20 per group). Discussion The STIMIT ACTIVATOR trial is a randomized multi-center study powered to elucidate whether non-invasive phrenic nerve stimulation is feasible, safe, and preserves diaphragm thickness. Meeting the primary endpoint will demonstrate its applicability in clinical practice to prevent diaphragmatic atrophy in ventilated patients.
Filiaciones:
Schreiber, AF:
Unity Hlth Toronto, St Michaels Hosp, Li Ka Shing Knowledge Inst, Keenan Res Ctr, Toronto, ON, Canada
Univ Toronto, Interdept Div Crit Care Med, Toronto, ON, Canada
Subirà, C:
Unity Hlth Toronto, St Michaels Hosp, Li Ka Shing Knowledge Inst, Keenan Res Ctr, Toronto, ON, Canada
Hosp Santa Creu & Sant Pau, Crit Care Dept, Barcelona, Spain
Inst Recerca St Pau IR St Pau, Crit Care Med Res, Barcelona, Spain
Inst Invest Carlos III, Ctr Invest Biomed Red Enfermedades Resp CIBERES, Madrid, Spain
Sklar, M:
Unity Hlth Toronto, St Michaels Hosp, Li Ka Shing Knowledge Inst, Keenan Res Ctr, Toronto, ON, Canada
Univ Toronto, Interdept Div Crit Care Med, Toronto, ON, Canada
Unity Hlth Toronto, St Michaels Hosp, Dept Anesthesia, Toronto, ON, Canada
Santos, M:
Univ Toronto, Interdept Div Crit Care Med, Toronto, ON, Canada
Ko, M:
Unity Hlth Toronto, St Michaels Hosp, Li Ka Shing Knowledge Inst, Keenan Res Ctr, Toronto, ON, Canada
Univ Toronto, Interdept Div Crit Care Med, Toronto, ON, Canada
Panelli, A:
Charite Univ Med Berlin, Berlin, Germany
Free Univ Berlin, Berlin, Germany
Humboldt Univ, Dept Anaesthesiol & Intens Care Med CCM CVK, Berlin, Germany
Schaller, SJ:
Charite Univ Med Berlin, Berlin, Germany
Free Univ Berlin, Berlin, Germany
Humboldt Univ, Dept Anaesthesiol & Intens Care Med CCM CVK, Berlin, Germany
Tech Univ Munich, Sch Med & Hlth, Dept Anaesthesiol & Intens Care Med, Klinikum Rechts Isar, Munich, Germany
Theodore, D:
Univ Virgina, Dept Anesthesiol & Crit Care Med, Charlottesville, VA USA
Rowley, DD:
Univ Virgina, Dept Anesthesiol & Crit Care Med, Charlottesville, VA USA
Watson, D:
Univ Virgina, Dept Anesthesiol & Crit Care Med, Charlottesville, VA USA
Bonde, P:
Yale Sch Med, Div Cardiac Surg, New Haven, CT USA
Kassis, ENB:
Harvard Med Sch, Beth Israel Deaconess Med Ctr, Div Pulm & Crit Care, Boston, MA USA
Talmor, DS:
Beth Israel Deaconess Med Ctr, Dept Anesthesia Crit Care & Pain Med, Boston, MA USA
Harvard Med Sch, Boston, MA USA
Ranieri, M:
Univ Turin, Dept Anesthesia & Intens Care Med, Turin, Italy
Goligher, EC:
Univ Toronto, Interdept Div Crit Care Med, Toronto, ON, Canada
Univ Hlth Network, Dept Med, Div Respirol, Toronto, ON, Canada
Slutsky, A:
Unity Hlth Toronto, St Michaels Hosp, Li Ka Shing Knowledge Inst, Keenan Res Ctr, Toronto, ON, Canada
Univ Toronto, Interdept Div Crit Care Med, Toronto, ON, Canada
Brochard, LJ:
Unity Hlth Toronto, St Michaels Hosp, Li Ka Shing Knowledge Inst, Keenan Res Ctr, Toronto, ON, Canada
Univ Toronto, Interdept Div Crit Care Med, Toronto, ON, Canada
Green Submitted, gold
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