Evidence map›Paper›PMID 30654837›Full record

ArticleTrials2019

Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial.

Douglas Evans, Deborah Shure, Linda Clark, Gerard J Criner, Martin Dres, Marcelo Gama de Abreu, Franco Laghi, David McDonagh, Basil Petrof, Teresa Nelson and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03096639 (Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
3.5field-weighted citation impact, top 7% of its field
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.

NCT03096639 nacompletednot on this map

Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing

TypeinterventionalSponsorLungpacer Medical Inc.Ran2017 to 2020Enrolled110ConditionsVentilator Induced Diaphragm DysfunctionArmsDiaphragmatic Pacing Therapy DPTS
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 32 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Managing respiratory muscle weakness during weaning from invasive ventilation.European respiratory review : an official journal of the European Respiratory Society · 2023
    Article
  11. Article
  12. Article
  13. Experimental biology and medicine (Maywood, N.J.) · 2022
    Article
  14. Article
  15. Preliminary Results of the Outpatient Endovascular and Interventional Society National Registry.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2020
    Article
  16. Article
  17. Review
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

11 authors at 9 institutions in 4 countries.

Douglas EvansLungpacer Medical Incorporated, Burnaby, BC, Canada.
Deborah ShureDeborah Shure MD PA, Miami, FL, USA.
Linda ClarkLungpacer Medical Incorporated, Burnaby, BC, Canada.
Gerard J CrinerDepartment of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.
Martin DresSorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique and AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie et Réanimation Médicale du Département R3S, Paris, France.
Marcelo Gama de AbreuDepartment of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
Franco LaghiDivision of Pulmonary and Critical Care Medicine, Hines Veterans Affairs Hospital Hines, Loyola University, Maywood, IL, USA.
David McDonaghDepartments of Anesthesiology and Pain Management, Neurological surgery, Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Basil PetrofMeakins-Christie Laboratories, and Translational Research in Respiratory Diseases Program, McGill University Health Centre and Research Institute, Montreal, QC, Canada.
Teresa NelsonTechnomics Research, LLC, Minneapolis, MN, USA.
Thomas SimilowskiSorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique and AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie et Réanimation Médicale du Département R3S, Paris, France. thomas.similowski@sorbonne-universite.fr.ORCID http://orcid.org/0000-0003-2868-9279
Inserm · FRLungpacer Medical (Canada) · CADeborah Heart and Lung Center · USEdward Hines, Jr. VA Hospital · USHealth Technomics (United States) · USMcGill University Health Centre · CATemple University · USThe University of Texas Southwestern Medical Center · USUniversity Hospital Carl Gustav Carus · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMechanical ventilation (MV) is a life-saving technology that restores or assists breathing. Like any treatment, MV has side effects. In some patients it can cause diaphragmatic atrophy, injury, and dysfunction (ventilator-induced diaphragmatic dysfunction, VIDD). Accumulating evidence suggests that VIDD makes weaning from MV difficult, which involves increased morbidity and mortality. METHODS AND ANALYSIS: This paper describes the protocol of a randomized, controlled, open-label, multicenter trial that is designed to investigate the safety and effectiveness of a novel therapy, temporary transvenous diaphragm pacing (TTVDP), to improve weaning from MV in up to 88 mechanically ventilated adult patients who have failed at least two spontaneous breathing trials over at least 7 days. Patients will be randomized (1:1) to TTVDP (treatment) or standard of care (control) groups. The primary efficacy endpoint is time to successful extubation with no reintubation within 48 h. Secondary endpoints include maximal inspiratory pressure and ultrasound-measured changes in diaphragm thickness and diaphragm thickening fraction over time. In addition, observational data will be collected and analyzed, including 30-day mortality and time to discharge from the intensive care unit and from the hospital. The hypothesis to be tested postulates that more TTVDP patients than control patients will be successfully weaned from MV within the 30 days following randomization. DISCUSSION: This study is the first large-scale clinical trial of a novel technology (TTVDP) aimed at accelerating difficult weaning from MV. The technology tested provides the first therapy directed specifically at VIDD, an important cause of delayed weaning from MV. Its results will help delineate the place of this therapeutic approach in clinical practice and help design future studies aimed at defining the indications and benefits of TTVDP.

trial registrationClinicalTrials.gov, NCT03096639 . Registered on 30 March 2017.

Indexed as

RespirationRespiration, ArtificialAirway ExtubationDiaphragmElectric Stimulation TherapyFranceGermanyHumansLength of StayLungMulticenter Studies as TopicPatient DischargeProspective StudiesRandomized Controlled Trials as TopicRecovery of FunctionRespiratory Function TestsDiaphragmMechanical ventilationPhrenic stimulationVentilator-induced diaphragmatic dysfunctionWeaning

Identifiers

PMID30654837
PMCPMC6337771
OpenAlexW2909141225

What OpenQuestion holds

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LicenceCC BY
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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.