Abdominal Functional Electrical Stimulation To Assist Ventilator Weaning In Critically Ill Patients
Neuroscience Research Australia
20 participants
Nov 11, 2017
Interventional
Conditions
Summary
The primary objective of this study is to investigate whether Abdominal Functional Electrical Stimulation (Abdominal FES) can prevent abdominal muscle atrophy during mechanical ventilation in critically ill patients. If feasible, data will be used to design a second, larger trial on clinically relevant endpoints. The secondary objectives of this study are to analyse whether this intervention also affects: (1) the thickness of the diaphragm, (2) respiratory function, (3) ventilation duration, (4) markers for systemic inflammation, (5) Intensive Care Unit (ICU) length of stay, (6) ICU and hospital representations, (7) re-intubations, (8) mortality and (9) quality of life.
Eligibility
Inclusion Criteria1
- mechanical ventilation dependence due to critical illness
Exclusion Criteria9
- pregnancy
- expected to be ventilated for < 24 hours (based on clinical judgement)
- ventilated for > 72 hours (to avoid excessive muscle atrophy)
- non-pharmacological paralysis (e.g. spinal cord injury or Guillain-Barré syndrome)
- physical obstacles that prevent Abdominal FES (e.g. severe abdominal trauma, pacemaker)
- terminal illness
- no response to Abdominal FES (e.g. lower motor neuron impairment)
- recent abdominal surgery within four weeks prior to study inclusion
- no clearly visible separate layers of the abdominal muscles (external oblique, internal oblique and transverse abdominal muscles), assessed with ultrasound during routine care
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Interventions
The abdominal muscles are the primary muscle group used during forced exhalation. We have shown that surface Functional Electrical Stimulation (FES) of the abdominal muscles, termed Abdominal FES, can improve respiratory function and assist weaning from mechanical ventilation in spinal cord injury. A pilot study of 11 ventilated critically ill patients found Abdominal FES maintained abdominal muscle thickness and decreased ventilation duration, however the sample size was too small to achieve statistical significance. We hypothesise that Abdominal FES in critically ill patients will reduce diaphragm and abdominal muscle atrophy, with the long term goal of this project to demonstrate reduced mechanical ventilation duration. Twenty critically ill patients being treated in the Intensive Care Unit (ICU) of the Prince of Wales Hospital, Sydney, will be recruited to this randomised, placebo controlled pilot trial. Participants will be recruited who are mechanically ventilated and are expected to remain that way for at least 48 hours. Ten patients will be randomly allocated to receive Abdominal FES and 10 will receive a placebo. In the Abdominal FES group, Abdominal FES will be applied for 30 minutes, twice per day, 5 days per week, until the patient is discharged from the ICU. Specifically, Abdominal FES will be delivered, via electrodes placed over the surface of the abdomen, at a frequency of 30 Hz and a pulse width of 350 µs. These settings are based on previous trials. The stimulation amplitude will initially be set to 60 mA, which corresponds to 90% of the maximum amplitude that was tolerated by healthy volunteers in a previous study. If this amplitude results in discomfort to the patient (based on clinical judgement) then it will be reduced as necessary. In addition, the stimulation amplitude will be evaluated five and 20 minutes after the start of each session to ensure that stimulation is still tolerable and causing a suitable muscle contraction. Ultrasound will be used to verify whether stimulation results in a contraction of the abdominal muscles during the first Abdominal FES session.
Locations(1)
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ACTRN12617001180303