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NMES to Prevent Respiratory Muscle Atrophy in Mechanically Ventilated Patients

NCT03453944 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-03-05

No results posted yet for this study

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.

Conditions

  • Mechanical Ventilation Complication
  • Neuromuscular Electrical Stimulation
  • Muscle Weakness

Interventions

DEVICE

VentFree prototype (VF03-K) active stimulation

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

DEVICE

VentFree prototype (VF03-K) sham stimulation

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

Sponsors & Collaborators

  • Liberate Medical

    collaborator INDUSTRY

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • Canisius-Wilhelmina Hospital

    collaborator OTHER

  • University Medical Center Nijmegen

    lead OTHER

Principal Investigators

  • Angelique ME Spoelstra-de Man, MD, PhD · Amsterdam UMC, location VUmc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2018-07-01
Completion
2018-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03453944 on ClinicalTrials.gov