An interventional study of VentFree prototype (VF03-K) active stimulation and VentFree prototype (VF03-K) sham stimulation in Mechanical Ventilation Complication, Neuromuscular Electrical Stimulation and Muscle Weakness, sponsored by University Medical Center Nijmegen. Status unknown at 3 sites in Netherlands. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-03-05.
Sponsored by University Medical Center Nijmegen · Not applicable, Interventional, and Prevention
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.
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.
477 studies on the registry are indexed under Muscle Weakness; 73 are open to participants now.
This study's planned enrollment of 20 is below the median of 44 across 362 interventional studies indexed under Muscle Weakness.
Browse Muscle Weakness studies →University Medical Center Nijmegen is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: VentFree prototype (VF03-K) active 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.
Device: VentFree prototype (VF03-K) sham stimulation
Abdominal wall muscle stimulation synchronised with mechanical ventilation. Stimulation frequency: 30 Hz, pulse width: 352us, max. intensity: 100mA (threshold intensity determined using ultrasound)
Abdominal wall muscle sham-stimulation synchronised with mechanical ventilation. Stimulation frequency: 10 Hz, pulse width: 352us, intensity: 15 mA.
Thickness of the abdominal wall muscles
Thickness of the abdominal wall muscles over time, for both groups, as measured by ultrasound.
Time frame: Until study completion, up to 6 weeks
Thickness of the diaphragm
Thickness of the diaphragm over time, for both groups, as measured by ultrasound.
Time frame: Until study completion, up to 6 weeks
Thickness of the rectus abdominis muscle
Thickness of the rectus abdominis mucle over time, for both groups, as measured by ultrasound.
Time frame: Until study completion, up to 6 weeks
Maximum expiratory pressure (MEP)
Maximum expiratory pressure (MEP) to assess expiratory muscle function
Time frame: Within 24 hours after extubation
Maximum inspiratory pressure (MIP)
Maximum inspiratory pressure (MIP) to assess inspiratory muscle function
Time frame: Within 24 hours after extubation
Vital capacity (Vc)
Vital capacity (Vc) to assess respiratory muscle strength
Time frame: Within 24 hours after extubation
Peak expiratory flow
Peak expiratory flow (PEF) to assess cough strength
Time frame: Within 24 hours after extubation
Number of patients with extubation failure
Weaning failure defined as the failure to pass a spontaneous-breathing trial or the need for reintubation within 48 hours following extubation
Time frame: Within 24 hours after extubation
Systemic inflammatory markers
Among others, cytokines IL-6 and IL-1 will be determined from blood sample analysis
Time frame: Within 24 hours after extubation
Number of patients with respiratory complications 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.
Time frame: Up to 6 weeks after ICU discharge
Expiratory flow limitation (optional)
EFL test to determine flow limitation in COPD
Time frame: Measured before the first NMES session and within 24 hours after extubation
Started Mar 2017 (actual). Primary completion is estimated for Jul 2018, 15 months after the start.
Of 200 non-industry interventional studies with no phase under Muscle Weakness, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 15 months is above that.
Counting every sponsor, half of 212 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Medical Center Nijmegen