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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03453944
Other study ID # LM-RB-01
Secondary ID
Status Recruiting
Phase N/A
First received April 25, 2017
Last updated February 26, 2018
Start date March 9, 2017
Est. completion date December 31, 2018

Study information

Verified date February 2018
Source University Medical Center Nijmegen
Contact Leo MA Heunks, MD, Prof
Phone 0204442209
Email l.heunks@vumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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 information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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)
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.

Locations

Country Name City State
Netherlands VU University Medical Center Amsterdam Noord-Holland
Netherlands Canisius Wilhelmina Hospital Nijmegen Gelderland
Netherlands UMC Nijmegen Nijmegen Gelderland

Sponsors (4)

Lead Sponsor Collaborator
University Medical Center Nijmegen Canisius-Wilhelmina Hospital, Liberate Medical, VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Expiratory flow limitation (optional) EFL test to determine flow limitation in COPD Measured before the first NMES session and within 24 hours after extubation
Primary Thickness of the abdominal wall muscles Thickness of the abdominal wall muscles over time, for both groups, as measured by ultrasound. Until study completion, up to 6 weeks
Secondary Thickness of the diaphragm Thickness of the diaphragm over time, for both groups, as measured by ultrasound. Until study completion, up to 6 weeks
Secondary Thickness of the rectus abdominis muscle Thickness of the rectus abdominis mucle over time, for both groups, as measured by ultrasound. Until study completion, up to 6 weeks
Secondary Maximum expiratory pressure (MEP) Maximum expiratory pressure (MEP) to assess expiratory muscle function Within 24 hours after extubation
Secondary Maximum inspiratory pressure (MIP) Maximum inspiratory pressure (MIP) to assess inspiratory muscle function Within 24 hours after extubation
Secondary Vital capacity (Vc) Vital capacity (Vc) to assess respiratory muscle strength Within 24 hours after extubation
Secondary Peak expiratory flow Peak expiratory flow (PEF) to assess cough strength Within 24 hours after extubation
Secondary 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 Within 24 hours after extubation
Secondary Systemic inflammatory markers Among others, cytokines IL-6 and IL-1 will be determined from blood sample analysis Within 24 hours after extubation
Secondary 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. Up to 6 weeks after ICU discharge
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