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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]

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

Condition category

Condition code

Surgery

Other surgery

Cardiovascular

Other cardiovascular diseases

Respiratory

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]

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]

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]

Cumulative data will be assessed at the conclusion of the study

Primary outcome [2]

Acceptability of IMT - via an IMT Acceptability Questionnaire. This questionnaire has been designed for this study

Timepoint [2]

Immediately prior to participants surgery

Primary outcome [3]

Consent and Recruitment rate including reasons for lack of consent - via patient interview and recording on study assessment form

Timepoint [3]

Cumulative data will be assessed at the conclusion of the study

Secondary outcome [1]

Change in Maximal Inspiratory Pressure (MIP) from baseline - via measurement with the IMT training device (primary outcome)

Timepoint [1]

Immediately prior to participants surgery, prior to participant hospital discharge

Secondary outcome [2]

Incidence of Post-operative Pulmonary Complications (PPCs) - via Melbourne Group Scale (MGS)

Timepoint [2]

Prior to participant hospital discharge, 6 weeks post-surgery

Secondary outcome [3]

Treatment time to achieve clinically significant increase in MIP - via recording on the study assessment form

Timepoint [3]

Immediately prior to participants surgery

Secondary outcome [4]

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]

At every IMT training timepoint

Secondary outcome [5]

Duration of Mechanical Ventilation - via ICU Metavision computer database

Timepoint [5]

At participant discharge from ICU to ward

Secondary outcome [6]

Gait speed - via 5metre walk track and stopwatch

Timepoint [6]

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]

Mortality

Timepoint [7]

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]

Post-operative complications - via Medical Record, Via ICU Metavision digital database

Timepoint [8]

Monitored daily post-surgery and recorded at timepoint of participant discharge from ICU to ward, and at participant hospital discharge

Secondary outcome [9]

Length of ICU admission - via Metavision computer database

Timepoint [9]

Monitored daily post surgery and recorded at time of participant discharge from ICU to ward

Secondary outcome [10]

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]

At time of participant hospital discharge

Secondary outcome [11]

Escalation of respiratory support and use of non-invasive ventilation - composite outcome measure. Via Medical record, Via ICU metavision computer data

Timepoint [11]

Measured daily post surgery until participant hospital discharge

Secondary outcome [12]

ICU readmission rate - via Medical Record, Via ICU Metavision computer data

Timepoint [12]

Daily from timepoint of participant discharge from ICU to ward

Secondary outcome [13]

Quality of Life - EQ-5L-5D

Timepoint [13]

At initial assessment and at 6 weeks post surgery on the EQ-5L-3D form

Secondary outcome [14]

Pain score - 0-10 scale

Timepoint [14]

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]

Self reported shortness of breath (SOB) - via Shortness of breath scale 0-10 designed for this study

Timepoint [15]

Daily until hospital discharge for intervention group. Daily after surgery until hospital discharge for control group. On written SOB scale.

Secondary outcome [16]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Prince Charles Hospital - Chermside

Recruitment postcode(s) [1]

4032 - Chermside

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Australian and New Zealand College of Anaesthetists - pilot grant

Address [1]

ANZCA Clinical Trials Network
ANZCA House
630 St Kilda Road
Melbourne Vic 3004

Country [1]

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]

None

Name [1]

none

Address [1]

none

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro North Health Human Research Ethics Committee B

Ethics committee address [1]

Metro North Health Human Research Ethics Committee
Metro North Office of Research
Royal Brisbane and Women's Hospital Campus
Level 7, Block 7, 
330B Herston Rd
Herston QLD 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/07/2022

Approval date [1]

12/08/2022

Ethics approval number [1]

HREC/2022/MNHB/84614

Summary

Brief summary

With any major surgery, there are risks of complications such as lung infection or pneumonia. These risks may be greater if surgery is urgent, patients must wait in hospital, and have limited physical activity.  We know that it is good to prepare physically for surgery and one way we are looking at is how best to do this with the lungs and breathing muscles. 
 Researchers have studied breathing muscle strengthening exercises before elective surgery and know that improving strength helps prevent complications, however we need to know more about what happens in the short period of time while patients are waiting in hospital for urgent surgery. Exercising with and without specific devices may assist, however we are not sure whether this works, what is best, how much and how strong the training should be, and whether patients having surgery will want to do the training or enjoy it.
In summary we want to know how to best prepare lungs before surgery in a short period of time, to know if higher-intensity exercise for the breathing muscles is better and to decide whether we could use this routinely on patients who would require urgent surgery. 
This study is comparing 2 groups of participants having urgent open-heart surgery, to see if there is a difference in inspiratory (breathing in) muscle strength with training. This is called inspiratory muscle training (IMT). One group will do exercises with the breathing strengthening device and one will not.  All participants in either intervention or control groups will receive usual pre-operative physiotherapy and other interventions that are currently provided.
It is hypothesised that short term, high-intensity IMT is feasible, safe and acceptable with patients in hospital awaiting urgent cardiac surgery. It is also hypothesised that short term, higher-intensity IMT will give a clinically significant increase in maximum inspiratory breathing pressure (MIP) from baseline.

Trial website

Trial related presentations / publications

Public notes

There are set criteria for participation in this study.  Any potential participants are provided with written information about the study, and face to face explanation. Once they understand the study, if they wish to participate, they sign a consent form. Participation is not compulsory, and withdrawl from the study can happen at any time.
Participants then perform two short tests – a measure of comfortable walk speed over 5-metres, and a breathing test to measure MIP. Participants are given a short questionnaire asking about general health and well-being, and after this, are randomly allocated to one of the two groups. Participants in the exercise group are taught how to do the inspiratory muscle training exercise and are visited daily by the physiotherapist to assist in these exercises. 
All participants will have their inspiratory muscle strength re-tested just before surgery and again a few days after surgery. Those participants who did the training will be asked questions about how they felt the training was, and if they had any pain when training. All participants will be asked how breathless they felt doing certain activities before surgery, and every day afterwards. Pain is assessed every day before and after surgery. The research physiotherapist will call participants around 6 weeks post-surgery to again complete the short health questionnaire.  All other treatment in hospital is the same as what would happen if there was no study.

Contacts

Principal investigator

Name

Dr Usha Gurunathan

Address

Senior Staff Specialist Anaesthetist
Department of Anaesthetics
The Prince Charles Hospital
Rode Rd Chermside QLD 4032

Country

Australia

Phone

+61 07 3139 4995

Fax

Usha.Gurunathan@health.qld.gov.au

Contact person for public queries

Name

Alison Mahoney

Address

Senior Physiotherapist
Physiotherapy Department
The Prince Charles Hospital
Rode Rd Chermside QLD 4032

Country

Australia

Phone

+61 07 3139 5440

Fax

Alison.Mahoney@health.qld.gov.au

Contact person for scientific queries

Name

Alison Mahoney

Address

Senior Physiotherapist
Physiotherapy Department
The Prince Charles Hospital
Rode Rd Chermside QLD 4032

Country

Australia

Phone

+61 07 3139 5440

Fax

Alison.Mahoney@health.qld.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Email	Attachment
16918	Study protocol	Alison.Mahoney@health.qld.gov.au	384528-(Uploaded-15-08-2022-17-37-15)-Study-related document.docx
16919	Informed consent form	Alison.Mahoney@health.qld.gov.au	384528-(Uploaded-15-08-2022-17-37-15)-Study-related document.doc
16920	Ethical approval	Alison.Mahoney@health.qld.gov.au	384528-(Uploaded-15-08-2022-17-37-15)-Study-related document.pdf

Results publications and other study-related documents

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No additional documents have been identified.

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