Evidence map›Paper›PMID 33126902›Full record

Trial reportCritical care (London, England)2020

Breath-synchronized electrical stimulation of the expiratory muscles in mechanically ventilated patients: a randomized controlled feasibility study and pooled analysis.

Annemijn H Jonkman, Tim Frenzel, Euan J McCaughey, Angus J McLachlan, Claire L Boswell-Ruys, David W Collins, Simon C Gandevia, Armand R J Girbes, Oscar Hoiting, Matthijs Kox and 15 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Critical care (London, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03453944 (Breath Synchronized Electrical Stimulation of the Abdominal Wall Muscles to Prevent Respiratory Muscle Atrophy During the Acute Stages of Mechanical Ventilation Therapy), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 21% 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.

NCT03453944 naunknown statusnot on this map

Breath Synchronized Electrical Stimulation of the Abdominal Wall Muscles to Prevent Respiratory Muscle Atrophy During the Acute Stages of Mechanical Ventilation Therapy

TypeinterventionalSponsorUniversity Medical Center NijmegenRan2017 to 2018Enrolled20ConditionsMechanical Ventilation Complication, Neuromuscular Electrical Stimulation, Muscle WeaknessArmsVentFree prototype (VF03-K) active stimulation, VentFree prototype (VF03-K) sham stimulation
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Guideline
  2. Pooled it
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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

25 authors at 8 institutions in 3 countries.

Annemijn H JonkmanDepartment of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.ORCID 0000-0001-8778-5135
Tim FrenzelDepartment of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
Euan J McCaugheyNeuroscience Research Australia, 139 Barker Street, Randwick, NSW, 2031, Australia.
Angus J McLachlanLiberate Medical LLC, Crestwood, KY, 40014, USA.
Claire L Boswell-RuysNeuroscience Research Australia, 139 Barker Street, Randwick, NSW, 2031, Australia.
David W CollinsPrince of Wales Hospital, Randwick, NSW, 2031, Australia.
Simon C GandeviaNeuroscience Research Australia, 139 Barker Street, Randwick, NSW, 2031, Australia.
Armand R J GirbesDepartment of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.
Oscar HoitingDepartment of Intensive Care Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.
Matthijs KoxDepartment of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
Eline OppersmaCardiovascular and Respiratory Physiology Group, Technical Medical Centre, University of Twente, Enschede, The Netherlands.
Marco PetersDepartment of Intensive Care Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.
Peter PickkersDepartment of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
Lisanne H RoesthuisDepartment of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
Jeroen SchoutenDepartment of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
Zhong-Hua ShiDepartment of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.
Peter H VeltinkDepartment of Biomedical Signals and Systems, Technical Medical Centre, University of Twente, Enschede, The Netherlands.
Heder J de VriesDepartment of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.
Cyndi Shannon WeickertNeuroscience Research Australia, 139 Barker Street, Randwick, NSW, 2031, Australia.
Carsten WiedenbachDepartment of Intensive Care Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.
Yingrui ZhangDepartment of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.
Pieter R TuinmanDepartment of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.
Angélique M E de ManDepartment of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.
Jane E ButlerNeuroscience Research Australia, 139 Barker Street, Randwick, NSW, 2031, Australia.
Leo M A HeunksDepartment of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands. L.Heunks@amsterdamumc.nl.
Amsterdam University Medical Centers · NLRadboud University Nijmegen · NLUNSW Sydney · AUCanisius-Wilhelmina Ziekenhuis · NLUniversity of Twente · NLAmsterdam Neuroscience · NLPrince of Wales Hospital · AUSUNY Upstate Medical University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundExpiratory muscle weakness leads to difficult ventilator weaning. Maintaining their activity with functional electrical stimulation (FES) may improve outcome. We studied feasibility of breath-synchronized expiratory population muscle FES in a mixed ICU population ("Holland study") and pooled data with our previous work ("Australian study") to estimate potential clinical effects in a larger group.

methodsHolland: Patients with a contractile response to FES received active or sham expiratory muscle FES (30 min, twice daily, 5 days/week until weaned). Main endpoints were feasibility (e.g., patient recruitment, treatment compliance, stimulation intensity) and safety. Pooled: Data on respiratory muscle thickness and ventilation duration from the Holland and Australian studies were combined (N = 40) in order to estimate potential effect size. Plasma cytokines (day 0, 3) were analyzed to study the effects of FES on systemic inflammation.

resultsHolland: A total of 272 sessions were performed (active/sham: 169/103) in 20 patients (N = active/sham: 10/10) with a total treatment compliance rate of 91.1%. No FES-related serious adverse events were reported. Pooled: On day 3, there was a between-group difference (N = active/sham: 7/12) in total abdominal expiratory muscle thickness favoring the active group [treatment difference (95% confidence interval); 2.25 (0.34, 4.16) mm, P = 0.02] but not on day 5. Plasma cytokine levels indicated that early FES did not induce systemic inflammation. Using a survival analysis approach for the total study population, median ventilation duration and ICU length of stay were 10 versus 52 (P = 0.07), and 12 versus 54 (P = 0.03) days for the active versus sham group. Median ventilation duration of patients that were successfully extubated was 8.5 [5.6-12.2] versus 10.5 [5.3-25.6] days (P = 0.60) for the active (N = 16) versus sham (N = 10) group, and median ICU length of stay was 10.5 [8.0-14.5] versus 14.0 [9.0-19.5] days (P = 0.36) for those active (N = 16) versus sham (N = 8) patients that were extubated and discharged alive from the ICU. During ICU stay, 3/20 patients died in the active group versus 8/20 in the sham group (P = 0.16).

conclusionExpiratory muscle FES is feasible in selected ICU patients and might be a promising technique within a respiratory muscle-protective ventilation strategy. The next step is to study the effects on weaning and ventilator liberation outcome.

trial registrationClinicalTrials.gov, ID NCT03453944. Registered 05 March 2018-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03453944 .

Indexed as

AgedAged, 80 and overCohort StudiesElectric StimulationFeasibility StudiesFemaleHospital MortalityHumansMaleMedicareProportional Hazards ModelsRespiration, ArtificialRespiratory MusclesRetrospective StudiesUnited StatesExpiratory musclesFunctional electrical stimulationMechanical ventilation

Identifiers

PMID33126902
PMCPMC7596623
OpenAlexW3095051235

What OpenQuestion holds

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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.