Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001032448p
Ethics application status
Submitted, not yet approved
Date submitted
2/04/2025
Date registered
17/09/2025
Date last updated
17/09/2025
Date data sharing statement initially provided
17/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the safety and feasibility of Inspiratory Muscle Training in ventilated (non-invasive and invasive) paediatric patients
Scientific title
Testing the safety and feasibility of Inspiratory Muscle Training in ventilated (non-invasive and invasive) paediatric patients
Secondary ID [1] 314061 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
respiratory muscle weakness 336808 0
Condition category
Condition code
Physical Medicine / Rehabilitation 333382 333382 0 0
Physiotherapy
Respiratory 333383 333383 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 330692 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341102 0
Safety
Timepoint [1] 341102 0
Baseline, each treatment episode, on completion of treatment.
Primary outcome [2] 341103 0
Feasibility
Timepoint [2] 341103 0
Baseline, each treatment episode, on completion of treatment.
Secondary outcome [1] 445597 0
Breathlessness
Timepoint [1] 445597 0
Baseline, at each intervention session, on completion of 10 sessions of intervention.
Secondary outcome [2] 446258 0
Physical function
Timepoint [2] 446258 0
Baseline, on completion of 10 sessions of intervention.
Secondary outcome [3] 446259 0
Respiratory muscle strength
Timepoint [3] 446259 0
Baseline, on completion of 10 sessions of intervention.
Secondary outcome [4] 446260 0
Diaphragm thickening fraction and end expiratory thickness
Timepoint [4] 446260 0
Baseline, on completion of 10 sessions of intervention.
Secondary outcome [5] 446261 0
Quality of life
Timepoint [5] 446261 0
Baseline, on completion of 10 sessions of intervention.

Eligibility
Key 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).
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

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
Statistical methods / analysis
Twelve participants will be recruited to the study. Descriptive statistics will be used to summarize baseline characteristics of the study participants, including demographic data, ventilatory status (invasive vs. non-invasive), and clinical parameters. Categorical data will be described as frequency (percentage) and continuous data as either mean (standard deviation) or median (interquartile range) depending on the distribution of the data. The feasibility of inspiratory muscle training (IMT) will be assessed by calculating the proportion of completed IMT sessions among eligible participants, with feasibility defined as a completion rate of =80%. Safety outcomes will be evaluated by recording the incidence of adverse events, categorized as major or minor, with a target of <3% minor adverse events and no major adverse events.

For secondary outcomes, changes in respiratory muscle strength, dyspnoea, quality of life, and physical strength over the 2-week IMT period will be analyzed. Depending on data distribution, paired t-tests or Wilcoxon signed-rank tests will be used for within-group comparisons. Repeated measures ANOVA or linear mixed models may be applied to assess trends over time. A p-value of <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
1/12/2026
Actual
Date of last data collection
Anticipated
18/12/2026
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 28485 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 43879 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 318566 0
Hospital
Name [1] 318566 0
Children's Health Queensland
Country [1] 318566 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 321037 0
None
Name [1] 321037 0
Address [1] 321037 0
Country [1] 321037 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317169 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 317169 0
Ethics committee country [1] 317169 0
Australia
Date submitted for ethics approval [1] 317169 0
11/09/2025
Approval date [1] 317169 0
Ethics approval number [1] 317169 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140226 0
Ms Alexandra Ferguson
Address 140226 0
Physiotherapy Department, Queensland Children's Hospital, 501 Stanley St, South Brisbane, Qld, 4101
Country 140226 0
Australia
Phone 140226 0
+61 730684544
Fax 140226 0
Email 140226 0
[email protected]
Contact person for public queries
Name 140227 0
Alexandra Ferguson
Address 140227 0
Physiotherapy Department, Queensland Children's Hospital, 501 Stanley St, South Brisbane, Qld, 4101
Country 140227 0
Australia
Phone 140227 0
+61 730684544
Fax 140227 0
Email 140227 0
[email protected]
Contact person for scientific queries
Name 140228 0
Alexandra Ferguson
Address 140228 0
Physiotherapy Department, Queensland Children's Hospital, 501 Stanley St, South Brisbane, Qld, 4101
Country 140228 0
Australia
Phone 140228 0
+61 730684544
Fax 140228 0
Email 140228 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email Principal Investigator [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.