Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001151729
Ethics application status
Approved
Date submitted
17/08/2022
Date registered
23/08/2022
Date last updated
23/08/2022
Date data sharing statement initially provided
23/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility, acceptability and change in inspiratory muscle strength in patients performing supervised breathing strengthening exercises using an inspiratory muscle trainer (IMT) device while waiting in hospital to have urgent cardiac surgery.
Scientific title
Pilot randomised controlled trial (RCT) aiming to primarily evaluate feasibility, acceptability, and change in inspiratory muscle strength (maximum inspiratory pressure - MIP) in patients performing supervised inspiratory muscle training using an inspiratory muscle trainer (IMT) device while waiting in hospital to have urgent cardiac surgery.
Secondary ID [1] 307776 0
none
Universal Trial Number (UTN)
Trial acronym
CARDIAC Surgery PReoperative INspiratory muscle Training - CARDIAC SPRINT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiothoracic Surgery 327354 0
Condition category
Condition code
Surgery 324479 324479 0 0
Other surgery
Cardiovascular 324526 324526 0 0
Other cardiovascular diseases
Respiratory 324527 324527 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is Inspiratory Muscle Training (IMT). This training is supervised by the research physiotherapist and is done with participant in the intervention group at a mutually convenient time on the ward where the participant is located until surgery. IMT is done by inspiring against resistance from an IMT device. The device used in this study is an electronic Powerbreathe. This is a portable TGA approved device that provides resistance to inspiration that can be modified to suit individual people and training load. The research physiotherapists in this study have all had greater than 8 years clinical experience and are experienced in research and in IMT and no specific training is required.
The research physiotherapist will supervise all IMT sessions and monitor safety by review of the medical record and observation chart, general observations, and monitoring of SpO2 and HR during and immediately after for 5 minutes post training using a portable oximeter. Blood pressure and respiratory rate will be measured pre and post training.
Participants will be suitable for IMT if there is a minimum of 2 days training available pre-surgery and they therefore can receive a minimum of 4 training sessions.
The participant’s Maximal Inspiratory Pressure (MIP) will be used to determine the appropriate training load. This is the highest inspiratory pressure generated by the participant as measured by the Powerbreathe. The research physiotherapist will prescribe a training intensity of at least 50% of MIP, and from there will titrate the highest tolerable intensity (up to maximum 80% of MIP) that allows the participant to just complete the 6th breath in a set of 6 breaths. The BORG rate of perceived exertion scale will be used to ensure intensity of training is sufficient. This will aim to be the equivalent of 14-16 on the BORG scale, and this scale will be measured at each session. The intensity will be increased by the research physiotherapist across the training period and across training sessions to ensure adequate training stimulus. Training will be performed twice daily on weekdays (morning and afternoon), with the research physiotherapist assisting the participant to perform 5 sets of 6 breaths each session. Weekend IMT will not be done due to potential poor performance with unsupervised sessions and limited physiotherapy staff. Between sets, participants are allowed a rest period as required, and there will be at least 4 hours between sessions. Each training session is expected to take approximately 20 minutes, and training will continue until the day of surgery. Training will occur no closer than 1 hour after a meal. Before and after each training session, participants will be asked to report any current symptoms of pain on a 0-10 scale, and other symptoms. The research physiotherapist will monitor for any adverse events and respond accordingly to ensure safety.
The intervention group also receive usual care. Usual care is standard physiotherapy pre-operative education. This is what is normally delivered to all patients having cardiothoracic surgery at this hospital, and involves watching video education, an opportunity to ask questions and written information in a booklet. This is delivered generally between 12-24 hours prior to surgery. The booklet and video are standard resources used at TPCH. The booklet called "Your guide to Cardiac Surgery" , and the video education (available on hospital TV loop and TPCH website) were developed by TPCH staff prior to this study and are standard practice.
Intervention code [1] 324240 0
Treatment: Devices
Comparator / control treatment
The control group only receive usual care. Usual care is standard physiotherapy pre-operative education. This is what is normally delivered to all patients having cardiothoracic surgery at this hospital, and involves watching standardised video education, an opportunity to ask questions and a written information booklet. This is delivered generally between 12-24 hours prior to surgery. The booklet and video are standard resources used at TPCH. The booklet called "Your guide to Cardiac Surgery" , and the video education (available on hospital TV loop and TPCH website) were developed by TPCH staff prior to this study and are standard practice.
Control group
Active

Outcomes
Primary outcome [1] 332305 0
Feasibility is a composite primary outcome - defined as 50 percent or more planned sessions completed, and 4 or more sessions completed - via recording on the study assessment form
Timepoint [1] 332305 0
Cumulative data will be assessed at the conclusion of the study
Primary outcome [2] 332307 0
Acceptability of IMT - via an IMT Acceptability Questionnaire. This questionnaire has been designed for this study
Timepoint [2] 332307 0
Immediately prior to participants surgery
Primary outcome [3] 332308 0
Consent and Recruitment rate including reasons for lack of consent - via patient interview and recording on study assessment form
Timepoint [3] 332308 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [1] 412927 0
Change in Maximal Inspiratory Pressure (MIP) from baseline - via measurement with the IMT training device (primary outcome)
Timepoint [1] 412927 0
Immediately prior to participants surgery, prior to participant hospital discharge
Secondary outcome [2] 412928 0
Incidence of Post-operative Pulmonary Complications (PPCs) - via Melbourne Group Scale (MGS)
Timepoint [2] 412928 0
Prior to participant hospital discharge, 6 weeks post-surgery
Secondary outcome [3] 412930 0
Treatment time to achieve clinically significant increase in MIP - via recording on the study assessment form
Timepoint [3] 412930 0
Immediately prior to participants surgery
Secondary outcome [4] 412931 0
Incidence of adverse events defined as follows: (i) haemodynamic instability (new arrhythmias - via ECG, alteration in mean arterial pressure requiring an alteration on in vasoactive medication, symptomatic change in SBP > 20mmHg, change in HR >20 bpm) - via BP machine, (ii) persistent increased RR > 10 breaths/min above baseline for 5 mins - via manual observation and count, (iii) increase in FiO2 during / immediately after the exercise session - via oximeter, (iv) increased patient agitation requiring medical intervention - via researcher observations, (vi) chest pain/other pain - via subjective assessment, (v) any additional events requiring medical intervention. - via subjective and objective assessment and observations
Timepoint [4] 412931 0
At every IMT training timepoint
Secondary outcome [5] 412932 0
Duration of Mechanical Ventilation - via ICU Metavision computer database
Timepoint [5] 412932 0
At participant discharge from ICU to ward
Secondary outcome [6] 412933 0
Gait speed - via 5metre walk track and stopwatch
Timepoint [6] 412933 0
Initial assessment- performed after consent is obtained and before randomisation. Final assessment - prior to participant hospital discharge (at approximately day 4 post surgery) recorded on study assessment form
Secondary outcome [7] 412934 0
Mortality
Timepoint [7] 412934 0
Via Medical record. Via The Viewer (web-based application available on desktop
computers and mobile devices that collates data from multiple Queensland Health systems) Monitored daily post-surgery during participant inpatient stay and recorded at 30 days post participant hospital discharge
Secondary outcome [8] 412935 0
Post-operative complications - via Medical Record, Via ICU Metavision digital database
Timepoint [8] 412935 0
Monitored daily post-surgery and recorded at timepoint of participant discharge from ICU to ward, and at participant hospital discharge
Secondary outcome [9] 412936 0
Length of ICU admission - via Metavision computer database
Timepoint [9] 412936 0
Monitored daily post surgery and recorded at time of participant discharge from ICU to ward
Secondary outcome [10] 412937 0
Length of hospital stay. Via Medical record. Via The Viewer (web-based application available on desktop computers and mobile devices that collates data from multiple Queensland Health systems)
Timepoint [10] 412937 0
At time of participant hospital discharge
Secondary outcome [11] 412938 0
Escalation of respiratory support and use of non-invasive ventilation - composite outcome measure. Via Medical record, Via ICU metavision computer data
Timepoint [11] 412938 0
Measured daily post surgery until participant hospital discharge
Secondary outcome [12] 412939 0
ICU readmission rate - via Medical Record, Via ICU Metavision computer data
Timepoint [12] 412939 0
Daily from timepoint of participant discharge from ICU to ward
Secondary outcome [13] 412940 0
Quality of Life - EQ-5L-5D
Timepoint [13] 412940 0
At initial assessment and at 6 weeks post surgery on the EQ-5L-3D form
Secondary outcome [14] 412941 0
Pain score - 0-10 scale
Timepoint [14] 412941 0
Daily until hospital discharge for intervention group. Daily after surgery until hospital discharge for control group. On a written marked 0-10 scale.
Secondary outcome [15] 412942 0
Self reported shortness of breath (SOB) - via Shortness of breath scale 0-10 designed for this study
Timepoint [15] 412942 0
Daily until hospital discharge for intervention group. Daily after surgery until hospital discharge for control group. On written SOB scale.
Secondary outcome [16] 413180 0
Days alive at home (30 days) Via Medical record. The Viewer (web-based application available on desktop computers and mobile devices that collates data from multiple Queensland Health systems)
Timepoint [16] 413180 0
After 30 days post-participant hospital discharge and prior to telephone follow up (at approximately 6 weeks)

Eligibility
Key inclusion criteria
Adult patients who can provide written informed consent and are admitted to TPCH for urgent cardiac surgery with cardiopulmonary bypass (for this study defined as patients admitted to hospital following the diagnosis of their heart condition and considered not safe to be discharged home before their surgery). Participants will be included in this study if they are determined to be at higher risk of developing PPCs as per current evidence. This would include one or more of the following:
• Current or recent smoker – defined as any amount of smoking history within 1 year of study recruitment
• Diagnosed COPD – defined by medical documentation of COPD, and/or respiratory function tests, and/or current or long-term use of respiratory medications
• Age greater than or equal to 70 years
• BMI greater than or equal to 30 kg/m2
• Clinical Frailty Scale greater than or equal to 4
• Diabetes Mellitus on pharmacological treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
• <18 years of age
• Unable to provide informed consent and/or unable to participate due to cognitive issues, intellectual disability or neurological impairment
• Emergency/salvage surgery or insufficient time to provide effective intervention (cardiac surgery within 48 hours of diagnosis, admission or recruitment)
• Patients discharged home prior to surgery
• Contraindications/precautions to IMT:
o Large emphysematous bullae
o Recent or current pneumothorax
o Recent lung anastomosis – within past 8 weeks
o Severe osteoporosis with high risk of rib fractures
o Current fractured or flail ribs
o Acute/unstable angina
o Known perforated eardrum
o Haemodynamic instability -new significant arrhythmias, alteration in BP requiring an alteration in vasoactive medication, Systolic BP > 180mmHg or <85, HR >130 or <50, and/or fluctuations in BP or HR causing symptoms, Acute/decompensated cardiac failure or severe/decompensated valvular disorders as determined by medical staff
o Significant pain affecting breathing capacity

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment is followed - participants are randomised using computer generated random number tables in concealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be done using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Blinding will be ensured by the following arrangement to separate the training and the assessments. Investigator 1: recruitment, consent, baseline data collection (MIP, gait speed, EQ-5D-5L, frailty), randomisation and daily training; SOB scale; pain scale; safety. Investigator 1 is blinded to all outcome measures.
Investigator 2: all measures after initial recruitment and assessment – MIP immediately pre-surgery and post-surgery; and all other primary and secondary outcomes except safety (determined by Investigator 1 during training). Investigator 2 is blinded to randomisation and intervention.
Demographic and participant data collected includes age, history of present condition, type of surgery, COPD/other respiratory disease, smoking history, diabetes mellitus, weight, height, other co-morbidities, previous sternotomy/other surgery, exercise history/tolerance, medications, ADL and relevant investigations such as RFTs, echo results. Frailty is recorded as per the Clinical Frailty Scale.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Continuous variables will be summarised as mean (SD) or median (IQR) as appropriate and categorical variables will be summarised as frequency (percentage). Baseline patient characteristics will be compared between groups using t-tests, non-parametric tests of chi-square tests as appropriate. Change from baseline to day 5 and/or immediately before surgery in the intervention group will be tested using a paired t-test. The effect of training, duration of training (time) and their interaction will be assessed using a linear mixed effects model.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2022
Actual
Date of last participant enrolment
Anticipated
2/09/2024
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22974 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 38280 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 312045 0
Other Collaborative groups
Name [1] 312045 0
Australian and New Zealand College of Anaesthetists - pilot grant
Country [1] 312045 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
The Prince Charles Hospital
Rode Rd
Chermside QLD 4032
Country
Australia
Secondary sponsor category [1] 313555 0
None
Name [1] 313555 0
none
Address [1] 313555 0
none
Country [1] 313555 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311459 0
Metro North Health Human Research Ethics Committee B
Ethics committee address [1] 311459 0
Ethics committee country [1] 311459 0
Australia
Date submitted for ethics approval [1] 311459 0
02/07/2022
Approval date [1] 311459 0
12/08/2022
Ethics approval number [1] 311459 0
HREC/2022/MNHB/84614

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

Contacts
Principal investigator
Name 121170 0
Dr Usha Gurunathan
Address 121170 0
Senior Staff Specialist Anaesthetist
Department of Anaesthetics
The Prince Charles Hospital
Rode Rd Chermside QLD 4032
Country 121170 0
Australia
Phone 121170 0
+61 07 3139 4995
Fax 121170 0
Email 121170 0
[email protected]
Contact person for public queries
Name 121171 0
Alison Mahoney
Address 121171 0
Senior Physiotherapist
Physiotherapy Department
The Prince Charles Hospital
Rode Rd Chermside QLD 4032
Country 121171 0
Australia
Phone 121171 0
+61 07 3139 5440
Fax 121171 0
Email 121171 0
[email protected]
Contact person for scientific queries
Name 121172 0
Alison Mahoney
Address 121172 0
Senior Physiotherapist
Physiotherapy Department
The Prince Charles Hospital
Rode Rd Chermside QLD 4032
Country 121172 0
Australia
Phone 121172 0
+61 07 3139 5440
Fax 121172 0
Email 121172 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD dissemination beyond this research group has not been approved by ethics.


What supporting documents are/will be available?




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.