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Trial registered on ANZCTR


Registration number
ACTRN12618000209291p
Ethics application status
Not yet submitted
Date submitted
1/02/2018
Date registered
9/02/2018
Date last updated
20/03/2020
Date data sharing statement initially provided
17/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Abdominal Functional Electrical Stimulation To Assist Ventilator Weaning In Critically Ill Patients: a randomised controlled trial
Scientific title
Abdominal Functional Electrical Stimulation To Assist Ventilator Weaning In Critically Ill Patients: a randomised controlled trial
Secondary ID [1] 293941 0
None
Universal Trial Number (UTN)
U1111-1208-8223
Trial acronym
Linked study record
ACTRN12617001180303

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 306434 0
Stroke 306435 0
Sepsis 306436 0
Traumatic Brain Injury 306437 0
Pneumonia 306438 0
Condition category
Condition code
Respiratory 305520 305520 0 0
Other respiratory disorders / diseases
Stroke 305521 305521 0 0
Haemorrhagic
Stroke 305522 305522 0 0
Ischaemic
Anaesthesiology 305523 305523 0 0
Anaesthetics
Physical Medicine / Rehabilitation 305524 305524 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 300208 0
Treatment: Devices
Comparator / control treatment
Participants in the placebo group will receive sham Abdominal FES for 45 minutes per day, five days per week, until discharge from the intensive care unit. Placebo Abdominal FES will be similar to active FES in all respects except for the simulation intensity, which will be kept to a level which does not cause a muscle contraction.

Specifically, stimulation pulses will be delivered at a frequency of 10 Hz and a low current amplitude (<10 mA) that does not cause abdominal muscle contraction. These settings were chosen so that participants experience the sensation of Abdominal FES without an abdominal muscle contraction. The placebo will be applied by a local physiotherapist.
Control group
Placebo

Outcomes
Primary outcome [1] 304651 0
Ventilation Duration measured in days post the start of mechanical ventilation, recorded from patient's medical record
Timepoint [1] 304651 0
When breathing independently of mechanical ventilation for 48 hours, or censored at 6 weeks for people who do not achieve independent ventilation
Secondary outcome [1] 342664 0
Thickness of the abdominal muscles as measured by ultrasound
Timepoint [1] 342664 0
48 hours after initiation of mechanical ventilation compared to when breathing independently of mechanical ventilation for 24 hours, or 6 weeks post ventilation for people who do not achieve independent ventilation.
Secondary outcome [2] 342665 0
Thickness of the diaphragm as measured by ultrasound
Timepoint [2] 342665 0
48 hours after initiation of mechanical ventilation compared to when breathing independently of mechanical ventilation for 24 hours, or 6 weeks post ventilation for people who do not achieve independent ventilation.
Secondary outcome [3] 342666 0
Maximum inspiratory pressure, measured using spirometry
Timepoint [3] 342666 0
when breathing independently of mechanical ventilation for 24 hours (note, outcome will not be assessed for patients who do not achieve independent ventilation).
Secondary outcome [4] 342667 0
Time in Intensive Care Unit (ICU), recorded from patient's medical record
Timepoint [4] 342667 0
At ICU discharge
Secondary outcome [5] 342668 0
Number of Re-intubations in intensive care, recorded from patient's medical record
Timepoint [5] 342668 0
Discharge from Intensive Care Unit
Secondary outcome [6] 342669 0
Readmissions to Intensive Care Unit, recorded from patient's medical record
Timepoint [6] 342669 0
At hospital discharge
Secondary outcome [7] 342670 0
Mortality
Timepoint [7] 342670 0
At hospital discharge
Secondary outcome [8] 342779 0
Maximum expiratory pressure, measured using spirometry
Timepoint [8] 342779 0
when breathing independently of mechanical ventilation for 24 hours (note, outcome will not be assessed for patients who do not achieve independent ventilation).
Secondary outcome [9] 342780 0
Forced vital capacity, measured using spirometry
Timepoint [9] 342780 0
when breathing independently of mechanical ventilation for 24 hours (note, outcome will not be assessed for patients who do not achieve independent ventilation).
Secondary outcome [10] 342781 0
Peak expiratory flow, measured using spirometry
Timepoint [10] 342781 0
when breathing independently of mechanical ventilation for 24 hours (note, outcome will not be assessed for patients who do not achieve independent ventilation).

Eligibility
Key inclusion criteria
mechanical ventilation dependence due to critical illness
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each participant will be randomly assigned to active or placebo Abdominal FES in a 1:1 ratio using a random, secure, web-based program (REDCap) by an independent investigator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome in this study is mechanical ventilation duration, with death before weaning from mechanical ventilation a competing event. Given the expected high level of mortality (~33%), and to avoid introducing bias due to participants who die while ventilated being unable to wean from mechanical ventilation, the primary outcome (ventilation duration) will be analysed using competing risk survival analysis. The cause-specific approach will be employed using ‘standard’ Cox regression analyses, with censoring at the competing event.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2020
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
254
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9928 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [2] 9929 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 18739 0
2031 - Randwick
Recruitment postcode(s) [2] 18740 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 298569 0
Government body
Name [1] 298569 0
National Health and Medical Research Council (NHMRC) Fellowship Funds
Country [1] 298569 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
139 Barker Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 297720 0
None
Name [1] 297720 0
Address [1] 297720 0
Country [1] 297720 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299535 0
Ethics committee address [1] 299535 0
Ethics committee country [1] 299535 0
Date submitted for ethics approval [1] 299535 0
01/01/2019
Approval date [1] 299535 0
Ethics approval number [1] 299535 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80762 0
Dr Euan McCaughey
Address 80762 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 80762 0
Australia
Phone 80762 0
+61293991827
Fax 80762 0
Email 80762 0
e.mccaughey@neura.edu.au
Contact person for public queries
Name 80763 0
Dr Euan McCaughey
Address 80763 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 80763 0
Australia
Phone 80763 0
+61293991827
Fax 80763 0
Email 80763 0
e.mccaughey@neura.edu.au
Contact person for scientific queries
Name 80764 0
Dr Euan McCaughey
Address 80764 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 80764 0
Australia
Phone 80764 0
+61293991827
Fax 80764 0
Email 80764 0
e.mccaughey@neura.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data security


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.