Skip to content

Abdominal Functional Electrical Stimulation To Assist Ventilator Weaning In Critically Ill Patients: a randomised controlled trial

Abdominal Functional Electrical Stimulation To Assist Ventilator Weaning In Critically Ill Patients: a randomised controlled trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000209291
Enrollment
254
Registered
2018-02-09
Start date
2020-06-01
Completion date
2023-06-30
Last updated
2020-03-30

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

Conditions

None listed

Brief summary

The primary objective of this study is to investigate whether Abdominal Functional Electrical Stimulation (Abdominal FES) can reduce mechanical ventilation duration in critically ill patients. The secondary objectives of this study are to analyse whether this intervention also affects: (1) the thickness of respiratory muscles, (2) respiratory function, (3) Intensive Care Unit (ICU) length of stay, (4) ICU and hospital representations, (5) re-intubations and (6) mortality.

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. We hypothesise that Abdominal FES in critically ill

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. We hypothesise that Abdominal FES in critically ill patients will reduce mechanical ventilation duration. Two hundred and fifty four critically ill patients being treated in the Intensive Care Unit (ICU) of the Prince of Wales Hospital, Sydney, and Royal North Shore Hospital, Sydney, will be recruited to this randomised, placebo controlled trial. Participants will be recruited who are mechanically ventilated and are expected to remain that way for at least 48 hours. 127 patients will be randomly allocated to receive Abdominal FES and 127 will receive a placebo. In the Abdominal FES group, Abdominal FES will be applied for 45 minutes per day, 5 days per week, until the patient is discharged from the ICU, by a local physiotherapist. Specifically, Abdominal FES will be delivered, via electrodes placed over the posterolateral surface of the abdomen. The stimulation amplitude will initially be set to 60 mA (50 Hz), 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 every five minutes to ensure that stimulation is still tolerable and causing a suitable muscle contraction.

Sponsors

Neuroscience Research Australia
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

mechanical ventilation dependence due to critical illness

Exclusion criteria

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. pregnancy, 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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026