Evidence map›Paper›PMID 40500715›Full record

ArticleTrials2025

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.

Annia F Schreiber, Carles Subirà, Michael Sklar, Marlene Santos, Matthew Ko, Alessandro Panelli, Stefan J Schaller, Danny Theodore, Daniel D Rowley, David Watson and 7 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05883163 (STIMIT Activator 1 Pivotal Study), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05883163 narecruitingnot on this map

STIMIT Activator 1 Pivotal Study

TypeinterventionalSponsorStimit AGRan2024 to 2026Enrolled40ConditionsDiaphragm IssuesArmsStimit Activator 1
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Annia F Schreiber *Keenan Research Centre, Li Ka Shing Knowledge Institute, Unity Health Toronto (St. Michael's Hospital), Toronto, ON, Canada.
Carles Subirà *Keenan Research Centre, Li Ka Shing Knowledge Institute, Unity Health Toronto (St. Michael's Hospital), Toronto, ON, Canada. carlessubira@gmail.com.
Michael SklarKeenan Research Centre, Li Ka Shing Knowledge Institute, Unity Health Toronto (St. Michael's Hospital), Toronto, ON, Canada.
Marlene SantosInterdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
Matthew KoKeenan Research Centre, Li Ka Shing Knowledge Institute, Unity Health Toronto (St. Michael's Hospital), Toronto, ON, Canada.
Alessandro PanelliCharité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Department of Anaesthesiology and Intensive Care Medicine (CCM/CVK), Berlin, Germany.
Stefan J SchallerCharité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, Department of Anaesthesiology and Intensive Care Medicine (CCM/CVK), Berlin, Germany.
Danny TheodoreUniversity of Virgina Department of Anesthesiology and Critical Care Medicine, Charlottesville, VA, USA.
Daniel D RowleyDepartment of Respiratory Therapy Services, University of Virginia Medical Center, Charlottesville, VA, USA.
David WatsonUniversity of Virgina Department of Anesthesiology and Critical Care Medicine, Charlottesville, VA, USA.
Pramod BondeDivision of Cardiac Surgery, Yale School of Medicine, New Heaven, CT, USA.
Elias N Baedorf KassisDivision of Pulmonary and Critical Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Daniel S TalmorDepartment of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.
Marco RanieriDepartment of Anesthesia and Intensive Care Medicine, University of Turin, Turin, Italy.
Ewan C GoligherInterdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
Arthur SlutskyKeenan Research Centre, Li Ka Shing Knowledge Institute, Unity Health Toronto (St. Michael's Hospital), Toronto, ON, Canada.
Laurent J BrochardKeenan Research Centre, Li Ka Shing Knowledge Institute, Unity Health Toronto (St. Michael's Hospital), Toronto, ON, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVentilator-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.

methodsA 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.

trial registrationClinicalTrials.gov: NCT05883163, August 29, 2023.

Indexed as

DiaphragmElectric Stimulation TherapyMuscular AtrophyPhrenic NerveRespiration, ArtificialAdaptive Clinical Trials as TopicEquivalence Trials as TopicHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeUnited StatesCritical careCritical illnessDiaphragmMechanical ventilationPhrenic nervePhrenic nerve stimulationUltrasonographyVentilator-induced diaphragm dysfunction

Identifiers

PMID40500715
PMCPMC12153206

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.