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Trial registered on ANZCTR


Registration number
ACTRN12619000968178
Ethics application status
Approved
Date submitted
31/05/2019
Date registered
9/07/2019
Date last updated
9/07/2019
Date data sharing statement initially provided
9/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of electronic strength training for ICU patients with breathing muscle weakness
Scientific title
Feasibility of electronic inspiratory muscle strength training for mechanically-ventilated ICU patients with inspiratory muscle weakness
Secondary ID [1] 298383 0
None
Universal Trial Number (UTN)
U1111-1234-5019
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ICU acquired weakness 313060 0
Respiratory failure 313061 0
Condition category
Condition code
Physical Medicine / Rehabilitation 311554 311554 0 0
Physiotherapy
Respiratory 311555 311555 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete electronic inspiratory muscle training under the direct supervision of a trained ICU physiotherapist (>5 years' clinical experience). Training will be performed in the ICU in the patient's bedspace.

Inspiratory muscle training will be performed with an electronic training device (Powerbreathe KH2, U.K). This device provides training from 1 - 200 cmH2O and can be connected to a patient's endotracheal tube or tracheostomy via a disposable connector.

The physiotherapist will prescribe a training intensity of at least 50% of maximum inspiratory pressure, and from there will titrate the highest tolerable intensity that allows the participant to just complete the 6th breath in a set of 6 breaths. Intensity will be increased by the physiotherapist across the training period to provide adequate training stimulus. Training will be performed daily on week days, with the physiotherapist assisting the patient to perform 5 sets of 6 breaths each session. Between sets, patients are allowed a rest period as required. The training session will take less than 10 minutes per day.

Training will continue daily until 6 weeks or hospital discharge, whichever occurs soonest.
Intervention code [1] 314626 0
Rehabilitation
Intervention code [2] 314627 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320262 0
Feasibility: % of planned sessions completed (as per medical record)
Timepoint [1] 320262 0
Hospital discharge or 6 weeks following commencement of training (whichever happens soonest)
Primary outcome [2] 320263 0
Safety: incidence of adverse events

Pre-defined adverse events:
• Unplanned airway removal (assessed clinically and as documented in medical record)
• Haemodynamic instability (new arrhythmias, alteration in mean arterial pressure requiring an alteration in vasoactive medication, change in SBP > 20mmHg, change in HR >20 bpm) as clinically assessed by the supervising physiotherapist
• Persistent increased RR > 10 breaths/min above baseline for 5 mins (as clinically assessed by the supervising physiotherapist)
• Increase in respiratory support (increase in FiO2 or PEEP) (as documented in medical record)
• Increased patient agitation requiring medical intervention (as reported in the medical record)
• Any additional events requiring medical intervention will also be recorded.
Timepoint [2] 320263 0
Hospital discharge, or 6 weeks following commencement of training, whichever occurs sooner.
Secondary outcome [1] 371028 0
Time breathing spontaneously on ventilator (duration of Pressure Support Ventilation) as recorded in Metavision data system
Timepoint [1] 371028 0
Point of successful weaning from mechanical ventilation (24 hours ventilator-free)
Secondary outcome [2] 371029 0
Change in maximum inspiratory pressure (measured with a respiratory pressure meter)
Timepoint [2] 371029 0
Hospital discharge or 6 weeks following commencement of training, whichever happens soonest.
Secondary outcome [3] 371030 0
Time to wean from mechanical ventilation (as recorded in Metavision data system)
Timepoint [3] 371030 0
Point of ventilatory weaning (ventilator-free for 24 hours) assessed for up to 3 months following enrolment
Secondary outcome [4] 371031 0
Acceptability of Intervention - Patient Questionnaire (study-specific)
Timepoint [4] 371031 0
Study completion: hospital discharge or 6 weeks following commencement, whichever occurs soonest
Secondary outcome [5] 371033 0
Dyspnoea (Borg Scale) as self-reported by patient (0 -1 0 scale)
Timepoint [5] 371033 0
Immediately prior to training, immediately following training and 5 minutes later
Secondary outcome [6] 372071 0
Heart rate, measured via ECG leads or portable SpO2 monitor
Timepoint [6] 372071 0
Immediately prior to training, immediately following training and 5 minutes later
Secondary outcome [7] 372079 0
Respiratory rate, measured by ventilator screen
Timepoint [7] 372079 0
Immediately prior to training, immediately following training and 5 minutes later
Secondary outcome [8] 372080 0
Pulse oxygen saturation, measured through pulse oximeter
Timepoint [8] 372080 0
Immediately prior to training, immediately following training and 5 minutes later
Secondary outcome [9] 372081 0
Blood pressure, measured via arterial line or sphygmomanometer (whichever is insitu)
Timepoint [9] 372081 0
Immediately prior to training, immediately following training and 5 minutes later

Eligibility
Key inclusion criteria
Mechanically ventilated > 5 days OR
Failed spontaneous breathing trial in past 24 hours
Alert and able to participate with training
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• New or existing condition likely to limit ability to follow simple commands (e.g. severe neurological injury, intellectual disability requiring assistance with personal ADLs)
• New or existing persistent respiratory dysfunction (e.g. high C-spine SCI)
• Poor prognosis
• Significant pain from chest trauma affecting breathing capacity
• Fractured or flail ribs
• Recent or current pneumothorax (undrained or drained)
• Treating intensivist recommends that a patient is not enrolled in the study (rationale to be documented to inform future study design).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Feasibility data will be analysed to describe the number of intended training sessions completed. Safety data will be reported as per pre-defined adverse outcomes and any new adverse events.
Descriptive statistics will be used to compare physiological parameters (HR, BP, MAP, SpO2, BORG) before and after training.
The change in maximum inspiratory strength across the training period will be analysed descriptively.
Qualitative data regarding patient acceptability of intervention (questionnaire) will be analysed and reported thematically.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,QLD
Recruitment hospital [1] 13880 0
The Canberra Hospital - Garran
Recruitment hospital [2] 13881 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 26652 0
2605 - Garran
Recruitment postcode(s) [2] 26653 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 302919 0
University
Name [1] 302919 0
University of Canberra
Address [1] 302919 0
Faculty of Health
University of Canberra
Bruce, ACT, 2617
Country [1] 302919 0
Australia
Funding source category [2] 302920 0
Charities/Societies/Foundations
Name [2] 302920 0
Queensland Cardiorespiratory Physiotherapy Network
Address [2] 302920 0
199 Ipswich Road
Woolloongabba, Queensland 4102
Country [2] 302920 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
Faculty of Health
University of Canberra
Bruce, ACT, 2617
Country
Australia
Secondary sponsor category [1] 302882 0
Hospital
Name [1] 302882 0
Princess Alexandra Hospital
Address [1] 302882 0
199 Ipswich Road
Woolloongabba, Queensland 4102
Country [1] 302882 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303489 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 303489 0
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 303489 0
Australia
Date submitted for ethics approval [1] 303489 0
Approval date [1] 303489 0
15/05/2019
Ethics approval number [1] 303489 0
HREC/2018/QMS/45151

Summary
Brief summary
Prolonged mechanical ventilation has been associated with significant respiratory muscle weakness that remains detectable 7 days post successful weaning. This weakness has been associated with difficulty weaning from mechanical ventilation. Inspiratory Muscle Training (IMT) is a novel physiotherapy technique that addresses respiratory muscle weakness. IMT uses progressive resistance to achieve a strengthening effect for respiratory muscles. Several high quality RCTs and a recent systematic review demonstrate IMT increases Maximal Inspiratory Pressure (MIP) in patients following prolonged mechanical ventilation. Furthermore a case series utilising threshold-based IMT have demonstrated safety and feasibility in ventilator dependent ICU patient. The resistance of this device is limited to 9 - 41cmH20, creating a ceiling and floor effect. Electronic inspiratory muscle training devices offer a greater magnitude of inspiratory resistance and may be more effective in providing precise assessments and training loads. However electronic inspiratory muscle training has received less attention in the literature, with only one pilot study indicating it could be feasible in ICU patients (Tonella et al 2017). While some European centres are already using electronic IMT and planning randomised trials using this technology (Hoffman et al 2018), the feasibility of this approach in ICU patients is yet to be established.

Before establishing efficacy of the electronic inspiratory muscle training device for mechanically ventilated patients, safety/feasibility of the intervention must be established. Therefore we are aiming to conduct a dual centre feasibility study with an aim to recruit 20 patients at both Princess Alexandra Hospital (Brisbane, Queensland) and Canberra Hospital. Eligible participants will be mechanically ventilated for greater than 5 days or have failed a spontaneous breathing trial. Furthermore participants will be required to have sufficient alertness to follow commands in order to participate with training whilst ventilated. Outcomes will evaluate both feasibility and safety of the intervention. We expect the electronic inspiratory muscle training device will be feasible to use in clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93834 0
A/Prof Bernie Bissett
Address 93834 0
12D44 University of Canberra
Bruce, ACT. 2617
Country 93834 0
Australia
Phone 93834 0
+61 2 6201 2566
Fax 93834 0
Email 93834 0
Bernie.Bissett@canberra.edu.au
Contact person for public queries
Name 93835 0
A/Prof Bernie Bissett
Address 93835 0
12D44 University of Canberra
Bruce, ACT. 2617
Country 93835 0
Australia
Phone 93835 0
+61 2 6201 2566
Fax 93835 0
Email 93835 0
Bernie.Bissett@canberra.edu.au
Contact person for scientific queries
Name 93836 0
A/Prof Bernie Bissett
Address 93836 0
12D44 University of Canberra
Bruce, ACT. 2617
Country 93836 0
Australia
Phone 93836 0
+61 2 6201 2566
Fax 93836 0
Email 93836 0
Bernie.Bissett@canberra.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
Patient privacy requirements as per ethical approval
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2857 0
Ethical approval
Citation [1] 2857 0
Link [1] 2857 0
Email [1] 2857 0
Other [1] 2857 0
Type [2] 2858 0
Informed consent form
Citation [2] 2858 0
Link [2] 2858 0
Email [2] 2858 0
Other [2] 2858 0
Type [3] 2859 0
Study protocol
Citation [3] 2859 0
Link [3] 2859 0
Email [3] 2859 0
Other [3] 2859 0
Summary results
No Results