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NMES to Prevent Respiratory Muscle Atrophy in Mechanically Ventilated Patients

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ClinicalTrials.gov Identifier: NCT03453944
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Collaborators:
Liberate Medical
VU University Medical Center
Canisius-Wilhelmina Hospital
Information provided by (Responsible Party):
Leo Heunks, VU University Medical Center

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.


Condition or disease Intervention/treatment Phase
Mechanical Ventilation Complication Neuromuscular Electrical Stimulation Muscle Weakness Device: VentFree prototype (VF03-K) active stimulation Device: VentFree prototype (VF03-K) sham stimulation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Breath Synchronized Electrical Stimulation of the Abdominal Wall Muscles to Prevent Respiratory Muscle Atrophy During the Acute Stages of Mechanical Ventilation Therapy
Actual Study Start Date : March 9, 2017
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: 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.
Device: VentFree 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)

Sham Comparator: 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.
Device: VentFree prototype (VF03-K) sham stimulation
Abdominal wall muscle sham-stimulation synchronised with mechanical ventilation. Stimulation frequency: 10 Hz, pulse width: 352us, intensity: 15 mA.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Thickness of the diaphragm [ Time Frame: Until study completion, up to 6 weeks ]
    Thickness of the diaphragm over time, for both groups, as measured by ultrasound.

  2. Thickness of the rectus abdominis muscle [ Time Frame: Until study completion, up to 6 weeks ]
    Thickness of the rectus abdominis mucle over time, for both groups, as measured by ultrasound.

  3. Maximum expiratory pressure (MEP) [ Time Frame: Within 24 hours after extubation ]
    Maximum expiratory pressure (MEP) to assess expiratory muscle function

  4. Maximum inspiratory pressure (MIP) [ Time Frame: Within 24 hours after extubation ]
    Maximum inspiratory pressure (MIP) to assess inspiratory muscle function

  5. Vital capacity (Vc) [ Time Frame: Within 24 hours after extubation ]
    Vital capacity (Vc) to assess respiratory muscle strength

  6. Peak expiratory flow [ Time Frame: Within 24 hours after extubation ]
    Peak expiratory flow (PEF) to assess cough strength

  7. Number of patients with extubation failure [ Time Frame: 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

  8. Systemic inflammatory markers [ Time Frame: Within 24 hours after extubation ]
    Among others, cytokines IL-6 and IL-1 will be determined from blood sample analysis

  9. Number of patients with respiratory complications after ICU discharge [ Time Frame: 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.


Other Outcome Measures:
  1. Expiratory flow limitation (optional) [ Time Frame: Measured before the first NMES session and within 24 hours after extubation ]
    EFL test to determine flow limitation in COPD



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453944


Contacts
Contact: Leo MA Heunks, MD, Prof 0204442209 l.heunks@vumc.nl
Contact: Annemijn H Jonkman, MSc 0204442209 ah.jonkman@vumc.nl

Locations
Netherlands
UMC Nijmegen Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Contact: Tim Frenzel, MD, PhD    +31 (0) 24 3665010    tim.frenzel@radboudumc.nl   
Canisius Wilhelmina Hospital Recruiting
Nijmegen, Gelderland, Netherlands, 6532 SZ
Contact: Jeroen Schouten, MD    +31 (0)24 - 365 7915    j.schouten@cwz.nl   
Contact: Mirjam Evers    +31 (0)24 - 365 7915    m.evers@cwz.nl   
VU University Medical Center Recruiting
Amsterdam, Noord-Holland, Netherlands, 1081 HV
Contact: Leo MA Heunks, MD, Prof       l.heunks@vumc.nl   
Contact: Angelique ME Spoelstra-de Man, MD, PhD       am.spoelstra@vumc.nl   
Sub-Investigator: Annemijn Jonkman, MSc         
Sponsors and Collaborators
University Medical Center Nijmegen
Liberate Medical
VU University Medical Center
Canisius-Wilhelmina Hospital
Investigators
Principal Investigator: Angelique ME Spoelstra-de Man, MD, PhD VU University Medical Center

Responsible Party: Leo Heunks, MD, Prof, VU University Medical Center
ClinicalTrials.gov Identifier: NCT03453944     History of Changes
Other Study ID Numbers: LM-RB-01
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Leo Heunks, VU University Medical Center:
Expiratory muscles
Mechanically ventilated patients
Neuromuscular electrical stimulation
Respiratory function
Ventilator-acquired muscle atrophy

Additional relevant MeSH terms:
Muscular Diseases
Neuromuscular Manifestations
Atrophy
Muscle Weakness
Paresis
Muscular Atrophy
Pathological Conditions, Anatomical
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms