NMES to Prevent Respiratory Muscle Atrophy in Mechanically Ventilated Patients
- Conditions
- Mechanical Ventilation ComplicationMuscle WeaknessNeuromuscular Electrical Stimulation
- Interventions
- Device: VentFree prototype (VF03-K) sham stimulationDevice: VentFree prototype (VF03-K) active stimulation
- Registration Number
- NCT03453944
- Lead Sponsor
- University Medical Center Nijmegen
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- age > 18 year
- invasive mechanical ventilation less than 72 hours
- expected duration of MV after inclusion > 72 hours
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VF03-K sham stimulation VentFree prototype (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. VF03-K active stimulation VentFree prototype (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.
- Primary Outcome Measures
Name Time Method Thickness of the abdominal wall muscles Until study completion, up to 6 weeks Thickness of the abdominal wall muscles over time, for both groups, as measured by ultrasound.
- Secondary Outcome Measures
Name Time Method Thickness of the diaphragm Until study completion, up to 6 weeks Thickness of the diaphragm over time, for both groups, as measured by ultrasound.
Maximum expiratory pressure (MEP) Within 24 hours after extubation Maximum expiratory pressure (MEP) to assess expiratory muscle function
Peak expiratory flow Within 24 hours after extubation Peak expiratory flow (PEF) to assess cough strength
Systemic inflammatory markers Within 24 hours after extubation Among others, cytokines IL-6 and IL-1 will be determined from blood sample analysis
Number of patients with respiratory complications after ICU discharge Up to 6 weeks after ICU discharge Number of patients with development of pneumonia, and readmission to the ICU due to atelectasis or respiratory problems that require mechanical ventilation.
Thickness of the rectus abdominis muscle Until study completion, up to 6 weeks Thickness of the rectus abdominis mucle over time, for both groups, as measured by ultrasound.
Maximum inspiratory pressure (MIP) Within 24 hours after extubation Maximum inspiratory pressure (MIP) to assess inspiratory muscle function
Vital capacity (Vc) Within 24 hours after extubation Vital capacity (Vc) to assess respiratory muscle strength
Number of patients with extubation failure Within 24 hours after extubation Weaning failure defined as the failure to pass a spontaneous-breathing trial or the need for reintubation within 48 hours following extubation
Trial Locations
- Locations (3)
UMC Nijmegen
🇳🇱Nijmegen, Gelderland, Netherlands
VU University Medical Center
🇳🇱Amsterdam, Noord-Holland, Netherlands
Canisius Wilhelmina Hospital
🇳🇱Nijmegen, Gelderland, Netherlands