Mechanical Ventilation ComplicationNCT03453944
NMES to Prevent Respiratory Muscle Atrophy in Mechanically Ventilated Patients
A study testing VentFree prototype (VF03-K) active stimulation in people with Mechanical Ventilation Complication and Neuromuscular Electrical Stimulation, run by University Medical Center Nijmegen at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Mechanical Ventilation Complication, Neuromuscular Electrical Stimulation, Muscle Weakness
- What is being tested?
- VentFree prototype (VF03-K) active stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesNetherlands
- Study dates
- 9 Mar 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 year
- invasive mechanical ventilation less than 72 hours
- expected duration of MV after inclusion > 72 hours
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites, 3 recruiting
- Recruiting
VU University Medical Center
Amsterdam, North Holland, 1081 HV
Leo MA Heunks, MD, Prof, l.heunks@vumc.nl
Angelique ME Spoelstra-de Man, MD, PhD, am.spoelstra@vumc.nl
- Recruiting
UMC Nijmegen
Nijmegen, Gelderland, 6525 GA
Tim Frenzel, MD, PhD, +31 (0) 24 3665010, tim.frenzel@radboudumc.nl
- Recruiting
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, 6532 SZ
Jeroen Schouten, MD, +31 (0)24 - 365 7915, j.schouten@cwz.nl
Mirjam Evers, +31 (0)24 - 365 7915, m.evers@cwz.nl
About this study
Official title: Breath Synchronized Electrical Stimulation of the Abdominal Wall Muscles to Prevent Respiratory Muscle Atrophy During the Acute Stages of Mechanical Ventilation Therapy
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.
Read the 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
- Being tested
- VentFree prototype (VF03-K) active stimulation, VentFree prototype (VF03-K) sham stimulation
- Keywords
- Expiratory muscles, Mechanically ventilated patients, Neuromuscular electrical stimulation, Respiratory function, Ventilator-acquired muscle atrophy
- Medical subject headings
- Muscle Weakness, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentFree prototype (VF03-K) active stimulationDevice
Abdominal wall muscle stimulation synchronised with mechanical ventilation. Stimulation frequency: 30 Hz, pulse width: 352us, max. intensity: 100mA (threshold intensity determined using ultrasound)
VentFree prototype (VF03-K) sham stimulationDevice
Abdominal wall muscle sham-stimulation synchronised with mechanical ventilation. Stimulation frequency: 10 Hz, pulse width: 352us, intensity: 15 mA.
| Study group | Role | What they receive |
|---|---|---|
| VF03-K active stimulation | Experimental | 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. Receives: Device: VentFree prototype (VF03-K) active stimulation |
| VF03-K sham stimulation | Sham comparator | 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. Receives: Device: VentFree prototype (VF03-K) sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of the abdominal wall muscles
Thickness of the abdominal wall muscles over time, for both groups, as measured by ultrasound.
Measured: Until study completion, up to 6 weeks
Secondary outcomes (9)
Thickness of the diaphragm
Thickness of the diaphragm over time, for both groups, as measured by ultrasound.
Measured: 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.
Measured: Until study completion, up to 6 weeks
Maximum expiratory pressure (MEP)
Maximum expiratory pressure (MEP) to assess expiratory muscle function
Measured: Within 24 hours after extubation
Maximum inspiratory pressure (MIP)
Maximum inspiratory pressure (MIP) to assess inspiratory muscle function
Measured: Within 24 hours after extubation
Vital capacity (Vc)
Vital capacity (Vc) to assess respiratory muscle strength
Measured: Within 24 hours after extubation
Peak expiratory flow
Peak expiratory flow (PEF) to assess cough strength
Measured: 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
Measured: Within 24 hours after extubation
Systemic inflammatory markers
Among others, cytokines IL-6 and IL-1 will be determined from blood sample analysis
Measured: 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.
Measured: Up to 6 weeks after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start9 Mar 2017
- Primary completion1 Jul 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Nijmegen
- Sponsor type
- University, hospital or other
- Collaborators
- Liberate Medical, Amsterdam UMC, location VUmc, Canisius-Wilhelmina Hospital
- Responsible party
- Principal investigator, Leo Heunks, Amsterdam UMC, location VUmc
- Investigators
- Angelique ME Spoelstra-de Man, MD, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453944
- Sponsor's protocol ID
- LM-RB-01
- Status last verified
- Feb 2018
- First submitted
- 25 Apr 2017
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33126902
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Synchronized Electrical Stimulation of the Abdominal Wall Muscles to Prevent Respiratory Muscle Atrophy During the Acute Stages of Mechanical Ventilation Therapy
- ClinicalTrials.gov ID
- NCT03453944
- Acronym / sponsor ID
- LM-RB-01
- Conditions
- Mechanical Ventilation Complication, Neuromuscular Electrical Stimulation, Muscle Weakness
- Keywords
- Expiratory muscles, Mechanically ventilated patients, Neuromuscular electrical stimulation, Respiratory function, Ventilator-acquired muscle atrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Medical Center NijmegenUniversity, hospital or other
- Collaborators
- Liberate Medical, Amsterdam UMC, location VUmc, Canisius-Wilhelmina Hospital
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VF03-K active stimulation | Experimental | Device: VentFree prototype (VF03-K) active stimulationNMES 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. |
| VF03-K sham stimulation | Sham comparator | Device: VentFree prototype (VF03-K) sham stimulationSham 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 year
- invasive mechanical ventilation less than 72 hours
- expected duration of MV after inclusion > 72 hours
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VentFree prototype (VF03-K) active stimulationAbdominal wall muscle stimulation synchronised with mechanical ventilation. Stimulation frequency: 30 Hz, pulse width: 352us, max. intensity: 100mA (threshold intensity determined using ultrasound) | Device | VF03-K active stimulation |
| VentFree prototype (VF03-K) sham stimulationAbdominal wall muscle sham-stimulation synchronised with mechanical ventilation. Stimulation frequency: 10 Hz, pulse width: 352us, intensity: 15 mA. | Device | VF03-K sham stimulation |
Primary outcome
Thickness of the abdominal wall muscles
Time frame: Until study completion, up to 6 weeks
Thickness of the abdominal wall muscles over time, for both groups, as measured by ultrasound.
9 secondary outcomes
Thickness of the diaphragm
Time frame: Until study completion, up to 6 weeks
Thickness of the rectus abdominis muscle
Time frame: Until study completion, up to 6 weeks
Maximum expiratory pressure (MEP)
Time frame: Within 24 hours after extubation
Maximum inspiratory pressure (MIP)
Time frame: Within 24 hours after extubation
Vital capacity (Vc)
Time frame: Within 24 hours after extubation
Peak expiratory flow
Time frame: Within 24 hours after extubation
Number of patients with extubation failure
Time frame: Within 24 hours after extubation
Systemic inflammatory markers
Time frame: Within 24 hours after extubation
Number of patients with respiratory complications after ICU discharge
Time frame: Up to 6 weeks after ICU discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Derived from this study: PubMed 33126902Jonkman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelique ME Spoelstra-de Man, MD, PhD principal investigator
Amsterdam UMC, location VUmc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VentFree prototype (VF03-K) active stimulation in people with Mechanical Ventilation Complication and Neuromuscular Electrical Stimulation, run by University Medical Center Nijmegen at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leo MA Heunks, MD, Prof (0204442209, l.heunks@vumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness of the abdominal wall muscles (time frame: Until study completion, up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03453944, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.