Mechanical Ventilation Complication, Muscle Weakness, Neuromuscular Electrical Stimulation
Conditions
Keywords
Expiratory muscles, Mechanically ventilated patients, Neuromuscular electrical stimulation, Respiratory function, Ventilator-acquired muscle atrophy
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.
Interventions
DEVICEVentFree 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)
DEVICEVentFree 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
Liberate Medical
Amsterdam UMC, location VUmc
Canisius-Wilhelmina Hospital
University Medical Center Nijmegen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Thickness of the diaphragm | Until study completion, up to 6 weeks | Thickness of the diaphragm over time, for both groups, as measured by ultrasound. |
| 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 expiratory pressure (MEP) | Within 24 hours after extubation | Maximum expiratory pressure (MEP) to assess expiratory muscle function |
| Maximum inspiratory pressure (MIP) | Within 24 hours after extubation | Maximum inspiratory pressure (MIP) to assess inspiratory muscle function |
| Peak expiratory flow | Within 24 hours after extubation | Peak expiratory flow (PEF) to assess cough 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 |
| 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. |
| Vital capacity (Vc) | Within 24 hours after extubation | Vital capacity (Vc) to assess respiratory muscle strength |
Other
| Measure | Time frame | Description |
|---|---|---|
| Expiratory flow limitation (optional) | Measured before the first NMES session and within 24 hours after extubation | EFL test to determine flow limitation in COPD |
Countries
Netherlands
Contacts
Primary ContactLeo MA Heunks, MD, Prof
Backup ContactAnnemijn H Jonkman, MSc
Outcome results
None listed