None listed
Conditions
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.
Interventions
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 physiotherapi
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.
Sponsors
University of Canberra
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Mechanically ventilated > 5 days OR Failed spontaneous breathing trial in past 24 hours Alert and able to participate with training
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).
Outcome results
None listed