NCT03453944

NMES to Prevent Respiratory Muscle Atrophy in Mechanically Ventilated Patients

Status unknown NA Last updated 5 March 2018

What this trial tests

NA trial testing VentFree prototype (VF03-K) active stimulation in Mechanical Ventilation Complication in 20 participants. Status unknown.

Timeline

9 March 2017

Primary endpoint
1 July 2018

31 December 2018

Quick facts

Lead sponsor	University Medical Center Nijmegen
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	20
Start date	9 March 2017
Primary completion	1 July 2018
Estimated completion	31 December 2018
Sites	3 locations across Netherlands

Drugs / interventions tested

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

Conditions studied

• Mechanical Ventilation Complication — all drugs for Mechanical Ventilation Complication →
• Neuromuscular Electrical Stimulation — all drugs for Neuromuscular Electrical Stimulation →
• Muscle Weakness — all drugs for Muscle Weakness →

Sponsor

University Medical Center Nijmegen

Who can join

Adults 18 to 99, any sex, with Mechanical Ventilation Complication or Neuromuscular Electrical Stimulation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical strategies for implementing lung and diaphragm-protective ventilation: avoiding insufficient and excessive effort.
   Goligher EC, Jonkman AH, Dianti J, Vaporidi K, et al · · 2020 · cited 118× · PMID 33140181 · DOI 10.1007/s00134-020-06288-9
2. Breath-synchronized electrical stimulation of the expiratory muscles in mechanically ventilated patients: a randomized controlled feasibility study and pooled analysis.
   Jonkman AH, Frenzel T, McCaughey EJ, McLachlan AJ, et al · · 2020 · cited 10× · PMID 33126902 · DOI 10.1186/s13054-020-03352-0