NMES to Prevent Respiratory Muscle Atrophy in Mechanically Ventilated Patients

Muscle Weakness Clinical Trial

Official title:

Breath Synchronized Electrical Stimulation of the Abdominal Wall Muscles to Prevent Respiratory Muscle Atrophy During the Acute Stages of Mechanical Ventilation Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03453944
• Other study ID #: LM-RB-01
• 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
• 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

Related Conditions & MeSH terms

• Atrophy
• Mechanical Ventilation Complication
• Muscle Weakness
• Muscular Atrophy
• Neuromuscular Electrical Stimulation
• Paresis

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