None listed
Conditions
Brief summary
Children who are supported on mechanical ventilation for a prolonged period of critical illness are at risk of developing respiratory muscle weakness which may lead to dependence on ventilatory support. Inspiratory muscle training (IMT) is a technique which has been proven in adults to help strengthen weakened respiratory muscles (such as the diaphragm and intercostal muscles) and may improve the success of liberating critically ill patients from mechanical ventilation (MV). This weakness can significantly impact the ability to wean from MV support and may subsequently lead to prolonged admissions to the intensive care unit, at a significant cost to the healthcare system (approximate cost per patient is in excess of $4000/day). Adult publications using IMT in prolonged ventilated patients have demonstrated several benefits, including increased inspiratory muscle strength, reduced weaning time from MV, and improved weaning success rates. It may also contribute to shorter ICU stays, as well as patient centered outcome measures such as reduced dyspnoea, physical function and improved quality of life (Bissett et.al, 2016, 2020, 2024). There are no published studies using IMT in children who are ventilated (non-invasive and invasive ventilation) despite the potential benefits of IMT in this patient group. This pilot trial aims to demonstrate that inspiratory muscle training (IMT) is safe and feasible for use in children who are ventilated (non-invasive or invasive ventilation).
Interventions
Inspiratory Muscle Training (IMT) in children ventilated =3 days (invasive and non-invasive ventilation) in the Paediatric Intensive Care Unit of the Queensland Children's Hospital. The device used will be the Powerbreathe Medic Plus IMT device.
The intervention will be delivered face-to-face and one on one by a specially trained physiotherapist. IMT training sessions will continue (irrespective of whether the patient remains on mechanical ventilation or is weaned/extubated), on weekdays Monda
Inspiratory Muscle Training (IMT) in children ventilated =3 days (invasive and non-invasive ventilation) in the Paediatric Intensive Care Unit of the Queensland Children's Hospital. The device used will be the Powerbreathe Medic Plus IMT device. The intervention will be delivered face-to-face and one on one by a specially trained physiotherapist. IMT training sessions will continue (irrespective of whether the patient remains on mechanical ventilation or is weaned/extubated), on weekdays Monday-Friday for 2 weeks (14 days) or until the patient is discharged, whichever is earlier. If the patient commences the study and then has to pause the study due to any of the reasons listed under exclusion criteria the patient may recommence from the study day they finished on and continue for the 14-day duration (10 sessions total). The maximum number of IMT sessions for any participant will be 10. The intervention will proceed as follows: The physiotherapist will explain the process to the patient and family/carer. The physiotherapist will disconnect the patient from mechanical ventilation and connect the IMT device (PowerBreathe Medic Plus device) to the ETT/tracheostomy/mask or mouthpiece. If the IMT is attached to a tracheostomy the cuff must be inflated to ensure accurate loading. The physiotherapist will set the threshold device to 50% of the maximum inspiratory pressure (MIP) for the first training set and instruct the patient to take 6 breaths in strongly against resistance. During the first training set the physiotherapist will increase the load to the highest tolerable load, that being the highest tolerable intensity that allows the participant to just complete the sixth breath in a set of six breaths. Five sets of 6 breaths will be completed each session. Patients are allowed to rest on the ventilator between sets. The total of 30 IMT breaths and rest will take approximately 10 minutes. Participants will complete the IMT program 5 days per week. IMT will be performed daily for at least 2 weeks (or until discharged if shorter). Each day the IMT PowerBreathe Medic Plus device resistance will start from the level of the previous day. During the first set of 6 breaths IMT the therapist increases the intensity by 1-2cm H2O as tolerated by the patient, so that each day they are achieving their highest tolerable intensity. The physiotherapist will be actively personalising the treatment to ensure 100percent adherance to the treament protocol. Any lack of adherance to the protocol will be documented in the session notes in the medical record.
Sponsors
Queensland Children's Hospital and Health Service
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
• Patients admitted to PICU and dependent on mechanical ventilation (invasive or non-invasive) =3 days and expected to be admitted to hospital for > 7 days aged =6 years and able to follow simple commands (Dassios & Dimitriou, 2019). • level of alertness corresponding to Richmond Agitation and Sedation Score (RASS, an instrument designed to assess the level of alertness and agitated behaviour in critically ill patients) of -1 to +1 (Kudchadkar et al., 2019) (Nickels et al., 2024). • FiO2 = 0.6, PEEP < 10 (Nickels et al., 2024). • Patients must be able to trigger spontaneous breaths on ventilator (Bissett et al., 2019). • Respiratory rate < 25 breaths per minute, as patients will struggle to maintain a faster rate during loaded breathing (Bissett et al., 2019).
Exclusion criteria
• Children younger than 6 years of age are excluded due to poor reliability in reproducible maneuvers requiring a maximal effort (Dassios & Dimitriou, 2019). • Patients who are not on active treatment (end of life or withdrawal of care). • Patients who are unable to participate due to decreased level of cognition or conscious state (RASS score above +1 or below -1). • Patients who are experiencing significant pain that interferes with breathing capacity (eg, fractured ribs, costochondritis or facial fractures) (Bissett et al., 2019; Bissett et al., 2016). Patients experiencing any of the following which are contraindications to IMT: • Medical instability i.e. where the medical treating team considers that interference with ventilatory support could compromise the patient’s state • Abdominal surgery in the previous 2 weeks and those with an abdominal hernia (Kulkarni et al., 2010) • Asthma patients who have a very low symptom perception and suffer from frequent and/or severe exacerbations, • Ruptured eardrum or any other condition of the ear • History of spontaneous pneumothorax • Pulmonary hypertension or large bullae on chest x-ray • Osteoporosis with history of spontaneous rib fractures • Patients with worsening heart failure signs such as tachycardia, tachypnoea, respiratory distress, and hypotension (Agrawal et al., 2024)
Outcome results
None listed