Clinical trial NCT03453944: NMES to Prevent Respiratory Muscle Atrophy in Mechanically Ventilated Patients
Official title: Breath Synchronized Electrical Stimulation of the Abdominal Wall Muscles to Prevent Respiratory Muscle Atrophy During the Acute Stages of Mechanical Ventilation Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mechanical Ventilation Complication
Neuromuscular Electrical Stimulation
Muscle Weakness
Keywords: Expiratory muscles
Mechanically ventilated patients
Neuromuscular electrical stimulation
Respiratory function
Ventilator-acquired muscle atrophy
Lead sponsor: University Medical Center Nijmegen
Sponsor class: OTHER
Collaborators: name: Liberate Medical
name: Amsterdam UMC, location VUmc
name: Canisius-Wilhelmina Hospital
First posted: 2018-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Thickness of the abdominal wall muscles
timeFrame: Until study completion, up to 6 weeks
Secondary outcomes:
measure: Thickness of the diaphragm
timeFrame: Until study completion, up to 6 weeks
measure: Thickness of the rectus abdominis muscle
timeFrame: Until study completion, up to 6 weeks
measure: Maximum expiratory pressure (MEP)
timeFrame: Within 24 hours after extubation
measure: Maximum inspiratory pressure (MIP)
timeFrame: Within 24 hours after extubation
measure: Vital capacity (Vc)
timeFrame: Within 24 hours after extubation
measure: Peak expiratory flow
timeFrame: Within 24 hours after extubation
measure: Number of patients with extubation failure
timeFrame: Within 24 hours after extubation
measure: Systemic inflammatory markers
timeFrame: Within 24 hours after extubation
measure: Number of patients with respiratory complications after ICU discharge
timeFrame: Up to 6 weeks after ICU discharge
Other outcomes:
measure: Expiratory flow limitation (optional)
timeFrame: Measured before the first NMES session and within 24 hours after extubation
Locations:
city: Nijmegen
country: Netherlands
facility: UMC Nijmegen
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Hospital
state: Gelderland
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Angelique ME Spoelstra-de Man, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.