NCT03453944

Brief Summary

Patients requiring prolonged time on the ventilator are susceptible to a wide range of clinical complications and excess mortality. It is therefore imperative for them to wean at the earliest possible time. Respiratory muscle weakness due to disuse of these muscles is a major underlying factor for weaning failure. Surprisingly, there is not much known about the impact of critical illness and MV on the expiratory abdominal wall muscles.These muscles are immediately activated as ventilation demands increase and are important in supporting respiratory function in patients with diaphragm weakness. Weakness of expiratory abdominal wall muscles will result in a decreased cough function and reduced ventilatory capacity. These are considerable causes of weaning failure and (re)hospitalisation for respiratory complications such as pneumonia. Recent evidence shows that neuromuscular electrical stimulation (NMES) can be used as a safe therapy to maintain skeletal muscle function in critically ill patients. This study will be the first to test the hypothesis that breath-synchronized NMES of the abdominal wall muscles can prevent expiratory muscle atrophy during the acute stages of MV.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 5, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

April 25, 2017

Last Update Submit

February 26, 2018

Conditions

Mechanical Ventilation ComplicationNeuromuscular Electrical StimulationMuscle Weakness

Keywords

Expiratory musclesMechanically ventilated patientsNeuromuscular electrical stimulationRespiratory functionVentilator-acquired muscle atrophy

Outcome Measures

Primary Outcomes (1)

  • Thickness of the abdominal wall muscles

    Thickness of the abdominal wall muscles over time, for both groups, as measured by ultrasound.

    Until study completion, up to 6 weeks

Secondary Outcomes (9)

  • Thickness of the diaphragm

    Until study completion, up to 6 weeks

  • Thickness of the rectus abdominis muscle

    Until study completion, up to 6 weeks

  • Maximum expiratory pressure (MEP)

    Within 24 hours after extubation

  • Maximum inspiratory pressure (MIP)

    Within 24 hours after extubation

  • Vital capacity (Vc)

    Within 24 hours after extubation

  • +4 more secondary outcomes

Other Outcomes (1)

  • Expiratory flow limitation (optional)

    Measured before the first NMES session and within 24 hours after extubation

Study Arms (2)

VF03-K active stimulation

EXPERIMENTAL

NMES applied to the abdominal wall muscles using the VentFree prototype (VF03-K). Stimulation is applied twice daily for 30 minutes, 5 days per week, for 6 weeks or until the patient is weaned from mechanical ventilation, whichever occurs sooner.

Device: VentFree prototype (VF03-K) active stimulation

VF03-K sham stimulation

SHAM COMPARATOR

Sham stimulation applied to the abdominal wall muscles using the VentFree prototype (VF03-K). Sham stimulation is applied twice daily for 30 minutes, 5 days per week, for 6 weeks or until the patient is weaned from mechanical ventilation, whichever occurs sooner.

Device: VentFree prototype (VF03-K) sham stimulation

Interventions

VentFree prototype (VF03-K) active stimulationDEVICE

Abdominal wall muscle stimulation synchronised with mechanical ventilation. Stimulation frequency: 30 Hz, pulse width: 352us, max. intensity: 100mA (threshold intensity determined using ultrasound)

VF03-K active stimulation
VentFree prototype (VF03-K) sham stimulationDEVICE

Abdominal wall muscle sham-stimulation synchronised with mechanical ventilation. Stimulation frequency: 10 Hz, pulse width: 352us, intensity: 15 mA.

VF03-K sham stimulation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 year
  • invasive mechanical ventilation less than 72 hours

You may not qualify if:

  • no clearly visible separate layers of the abdominal wall muscles (external oblique, internal oblique and transverse abdominal muscles), assessed with ultrasound during routine care
  • cardiac pacemaker
  • congenital myopathies and/or existing central or peripheral neuropathies
  • refractory epilepsy
  • body mass index (BMI) greater than 35 kg/m2
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UMC Nijmegen

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, 6532 SZ, Netherlands

RECRUITING

VU University Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Related Publications (1)

  • Jonkman AH, Frenzel T, McCaughey EJ, McLachlan AJ, Boswell-Ruys CL, Collins DW, Gandevia SC, Girbes ARJ, Hoiting O, Kox M, Oppersma E, Peters M, Pickkers P, Roesthuis LH, Schouten J, Shi ZH, Veltink PH, de Vries HJ, Shannon Weickert C, Wiedenbach C, Zhang Y, Tuinman PR, de Man AME, Butler JE, Heunks LMA. Breath-synchronized electrical stimulation of the expiratory muscles in mechanically ventilated patients: a randomized controlled feasibility study and pooled analysis. Crit Care. 2020 Oct 30;24(1):628. doi: 10.1186/s13054-020-03352-0.

    PMID: 33126902DERIVED

MeSH Terms

Conditions

Muscle WeaknessRespiratory Aspiration

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Angelique ME Spoelstra-de Man, MD, PhD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leo MA Heunks, MD, Prof

CONTACT

0204442209l.heunks@vumc.nl

Annemijn H Jonkman, MSc

CONTACT

0204442209ah.jonkman@vumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Prof

Study Record Dates

First Submitted

April 25, 2017

First Posted

March 5, 2018

Study Start

March 9, 2017

Primary Completion

July 1, 2018

Study Completion

December 31, 2018

Last Updated

March 5, 2018

Record last verified: 2018-02

Locations

NL(3)