NMES to Prevent Respiratory Muscle Atrophy in Mechanically Ventilated Patients

NCT ID: NCT03453944

Last Updated: 2018-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-09
• Study Completion Date: 2018-12-31

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.

Detailed Description

Approximately 30-40% of intubated patients at the intensive care unit (ICU) take more than one attempt to wean from mechanical ventilation (MV). 6-14% of intubated patients take longer than 7 days to wean from MV. 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. It is known that diaphragm strength rapidly declines within a few days after the initiation of MV. 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, e.g. by stimulating quadriceps muscles in patients receiving MV.

This study will be the first to test the hypothesis that exhalation synchronized NMES of the abdominal wall muscles can prevent expiratory muscle atrophy during the acute stages of MV. The investigators hypothesize that this approach will improve respiratory function and thereby will reduce the amount of time it takes to wean patients from mechanical ventilation.

Conditions

Mechanical Ventilation Complication; Neuromuscular Electrical Stimulation; Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

VF03-K active stimulation

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.

Group Type: EXPERIMENTAL

VentFree prototype (VF03-K) active stimulation

Intervention Type: DEVICE

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 sham stimulation

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.

Group Type: SHAM_COMPARATOR

VentFree prototype (VF03-K) sham stimulation

Intervention Type: DEVICE

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

Interventions

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)

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• age > 18 year
• invasive mechanical ventilation less than 72 hours
• expected duration of MV after inclusion > 72 hours

Exclusion Criteria

• 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
• recent abdominal surgery within four weeks prior to study inclusion
• body mass index (BMI) greater than 35 kg/m2
• pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liberate Medical

INDUSTRY

Sponsor Role: collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: collaborator

Canisius-Wilhelmina Hospital

OTHER

Sponsor Role: collaborator

University Medical Center Nijmegen

OTHER

Sponsor Role: lead

Responsible Party

Leo Heunks

MD, Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angelique ME Spoelstra-de Man, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

UMC Nijmegen

Nijmegen, Gelderland, Netherlands

Site Status: RECRUITING

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, Netherlands

Site Status: RECRUITING

VU University Medical Center

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Leo MA Heunks, MD, Prof

Role: CONTACT

l.heunks@vumc.nl

0204442209

Annemijn H Jonkman, MSc

Role: CONTACT

ah.jonkman@vumc.nl

0204442209

Facility Contacts

Tim Frenzel, MD, PhD

Role: primary

tim.frenzel@radboudumc.nl

+31 (0) 24 3665010

Jeroen Schouten, MD

Role: primary

j.schouten@cwz.nl

+31 (0)24 - 365 7915

Mirjam Evers

Role: backup

m.evers@cwz.nl

+31 (0)24 - 365 7915

Leo MA Heunks, MD, Prof

Role: primary

l.heunks@vumc.nl

Angelique ME Spoelstra-de Man, MD, PhD

Role: backup

am.spoelstra@vumc.nl

References

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.

Reference Type: DERIVED

PMID: 33126902 (View on PubMed)

Other Identifiers

LM-RB-01

Identifier Type: -

Identifier Source: org_study_id