Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001015639
Ethics application status
Approved
Date submitted
30/08/2023
Date registered
19/09/2023
Date last updated
19/09/2023
Date data sharing statement initially provided
19/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of frailty on inspiratory muscle strength among older adults post elective cardiac surgeries
Scientific title
Evaluating the effect of frailty on inspiratory muscle strength among older adults post elective cardiac surgeries
Secondary ID [1] 310501 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elderly persons 331295 0
frailty 331296 0
cardiac disease 331297 0
Condition category
Condition code
Cardiovascular 328055 328055 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 328056 328056 0 0
Physiotherapy
Respiratory 328142 328142 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Following provision of informed consent from the participants, participants will be required to complete a series of outcome measures which include a lung function test via a portable spirometry and a inspiratory muscle strength test via a Sniff Nasal Inspiratory Pressure (SNIP) machine. These outcome measures will be repeated once again at time of discharge from hospital post elective cardiac surgery to ascertain changes to the inspiratory muscle strength following cardiac surgery

Initial testing will occur at cardiothoracic preadmission clinic. Patients attend cardiothoracic preadmission clinic when their scheduled cardiac surgery is between 2 weeks to 1 month.
Duration of testing is approximately 5 minutes, time may vary depending on patients understanding the instructions
Intervention code [1] 326894 0
Early Detection / Screening
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335923 0
Inspiratory muscle strength

Inspiratory muscule strength measured by SNIP (Sniff Nasal Inspiratory Pressure) device
Timepoint [1] 335923 0
At baseline and at postoperative day 5
Secondary outcome [1] 426157 0
Lung function test
Timepoint [1] 426157 0
Lung function will be assessed by spirometer, at postoperative day 5 and on the day of discharge
Secondary outcome [2] 426806 0
Postoperative pulmonary complications (PPCs), e.g. chest x-ray radiological report of atelectasis/consolidation, an unexplained white cell count exceeding 11.2 cells/mm3 or administration of respiratory antibiotics postoperatively, fever (oral temperature > 38 degrees) with no obvious non-pulmonary focus, positive signs of infection on sputum microbiology, production of purulent (yellow/green) sputum that was different from preoperative status, percutaneous oxygen saturation < 90% on room air diagnosis of pneumonia/chest infection by attending physician, readmission to the intensive care (ICU) or high-dependency unit (HDU) or a prolonged stay (>36 hours) in ICU or HDU due to respiratory problems.
A member of the research team will be screening through the participant’s medical history to ascertain the occurrence of PPCs. PPC is said to have occurred based on the presence of four or more of the examples provided.
Timepoint [2] 426806 0
Data collected on the day of discharge
Secondary outcome [3] 426807 0
Length of stay in hospital.
The outcome will be obtained from medical records
Timepoint [3] 426807 0
Data collected on the day of discharge

Eligibility
Key inclusion criteria
To be eligible, participants are required to:
- Be over the age of 65 years
- Possess a score of six or less on the Rockwood Clinical Frailty Score (RCFS).
- Undergoing elective cardiac surgery via sternotomy.

Patients from non-English speaking backgrounds who require language assistance will be included to ensure the sample represents the population at SWSLHD. An interpreter or a family member nominated by the participant will assist in interpretations during the recruitment and throughout the study.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Undergoing a minimally invasive/emergency cardiac procedure
- Presence of neuromuscular disease based on documented past medical history in the medical notes.
- Anyone with cognitive deficits assessed by a medical profession

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
An intention to treat analysis will be conducted for the purpose of this study. Changes in inspiratory muscle pressure between baseline and post-operative will be analysed descriptively. The rate of PPCs between the non-frail and frail groups will be analysed using the independent T-test. Repeated ANOVA will be used to analyse between group differences in MIP and spirometry results. All data analysis will be conducted using SPSS v26 (IBM) available through UNSW.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/10/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25474 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 41285 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 314703 0
University
Name [1] 314703 0
Western Sydney University
Country [1] 314703 0
Australia
Primary sponsor type
University
Name
UNSW
Address
UNSWSydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 316673 0
Hospital
Name [1] 316673 0
Liverpool Hospital
Address [1] 316673 0
Elizabeth Drive,Liverpool, NSW 2170
Country [1] 316673 0
Australia
Other collaborator category [1] 282804 0
University
Name [1] 282804 0
Victoria University
Address [1] 282804 0
70/104 Ballarat RoadFootscray, Victoria 3011
Country [1] 282804 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313775 0
South Western Sydney Local Health District HREC
Ethics committee address [1] 313775 0
SWSOHD Locked Bag 7279 Eastern CampusLiverpool BC NSW 1871
Ethics committee country [1] 313775 0
Australia
Date submitted for ethics approval [1] 313775 0
Approval date [1] 313775 0
06/04/2021
Ethics approval number [1] 313775 0
2021/ETH00133

Summary
Brief summary
Older people are more likely to develop postoperative pulmonary complications (PPCs) after cardiac surgery due to the possible age-related decline in inspiratory muscle strength. We aim to investigate the impact of frailty on inspiratory. muscle strength amongst older people following elective cardiac surgeries. We also aim to investigate the impact of frailty on lung function and PPCs. The findings of the study may elucidate potential means to identify individuals who may be more at risk of PPCs following surgery and could assist in the development of tailored post-surgical management strategies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129118 0
Dr Serena Hong
Address 129118 0
UNSWSydney, NSW 2052
Country 129118 0
Australia
Phone 129118 0
+61 290652348
Fax 129118 0
Email 129118 0
[email protected]
Contact person for public queries
Name 129119 0
Dr Serena Hong
Address 129119 0
UNSWSydney, NSW 2052
Country 129119 0
Australia
Phone 129119 0
+61 290652348
Fax 129119 0
Email 129119 0
[email protected]
Contact person for scientific queries
Name 129120 0
Dr Serena Hong
Address 129120 0
UNSWSydney, NSW 2052
Country 129120 0
Australia
Phone 129120 0
+61 290652348
Fax 129120 0
Email 129120 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable participant data underlying published results
When will data be available (start and end dates)?
ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of primary sponsor
Available for what types of analyses?
to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal investigator. PI can be contacted by email, [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20180Study protocol  [email protected]



Results publications and other study-related documents

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Documents added automatically
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