Breath synchronized electrical stimulation of the abdominal wall muscles to prevent respiratory muscle atrophy during the acute stages of mechanical ventilation therapy

Breath synchronized electrical stimulation of the abdominal wall muscles to prevent respiratory muscle atrophy during the acute stages of mechanical ventilation therapy - NMES to prevent respiratory muscle atrophy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46155

Enrollment

Registered

2016-05-24

Start date

2017-03-09

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory muscle weakness due to mechanical ventilation weaning failure

Interventions

The intervention will be NMES (versus a sham [control] intervention) applied to the abdominal wall muscles for 30 minutes per session, twice a day, 5 days per week, for 6 weeks or until the patient i

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - informed consent - age > 18 year - invasive mechanical ventilation less than 72 hours - expected duration of MV after inclusion > 72 hours

Exclusion criteria

Exclusion criteria: - no visible abdominal wall muscles, assessed with ultrasound during routine care - cardiac pacemaker - congenital myopathies and/or existing central or peripheral neuropathies - recent abdominal surgery within four weeks prior to study inclusion - refractory / uncontrolled epilepsy - BMI > 35 - pregnancy

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the thickness of the abdominal wall muscles during end-inspiration (ITabd) and end-expiration (ETabd), for both groups, as measured by ultrasound.	—

Secondary

Measure	Time frame
The secondary endpoints are: - the thickening fraction (TF) of the abdominal wall muscles: TFadb = (ITabd - ETabd) / ETabd x 100% - the thickness of the diaphragm during end-inspiration (ITdi) and end-expiration (ETdi) - the thickening fraction of the diaphragm: TFdi = (ITdi - ETdi) / ETdi x 100% - echogenicity of the abdominal wall muscles - the thickness of the rectus abdominis muscle - functional respiratory measurements: vital capacity (VC), maximal expiratory pressure (MEP), maximal inspiratory pressure (MIP), cough pressure - blood inflammatory markers (IL-6, IL-1, IL-8) - weaning outcome During follow-up: - readmission to the ICU due to respiratory problems - pneumonia acquired after ICU discharge. These outcomes will be compared between both groups. At last, feasibility parameters will be investigated: - Estimated sample size for a larger randomized control trial, based on the primary outcome parameter. - Time needed to recruit patients - Number of eligible patients: as number of the total ICU population - Replacement rate after first stimulation test with ultrasound verification of contraction during stimulation	—

Measure

Time frame

The secondary endpoints are: - the thickening fraction (TF) of the abdominal wall muscles: TFadb = (ITabd - ETabd) / ETabd x 100% - the thickness of the diaphragm during end-inspiration (ITdi) and end-expiration (ETdi) - the thickening fraction of the diaphragm: TFdi = (ITdi - ETdi) / ETdi x 100% - echogenicity of the abdominal wall muscles - the thickness of the rectus abdominis muscle - functional respiratory measurements: vital capacity (VC), maximal expiratory pressure (MEP), maximal inspiratory pressure (MIP), cough pressure - blood inflammatory markers (IL-6, IL-1, IL-8) - weaning outcome During follow-up: - readmission to the ICU due to respiratory problems - pneumonia acquired after ICU discharge. These outcomes will be compared between both groups. At last, feasibility parameters will be investigated: - Estimated sample size for a larger randomized control trial, based on the primary outcome parameter. - Time needed to recruit patients - Number of eligible patients: as number of the total ICU population - Replacement rate after first stimulation test with ultrasound verification of contraction during stimulation

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)