ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001397202

Ethics application status

Approved

Date submitted

16/08/2018

Date registered

20/08/2018

Date last updated

3/12/2020

Date data sharing statement initially provided

3/12/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Do cardiac surgery patients have weak breathing muscles before surgery? An observational study

Scientific title

Prevalence of inspiratory muscle weakness in pre-operative cardiac surgery patients: an observational study.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1219-0781

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cardiac surgery

respiratory muscle weakness

post-operative pulmonary complications

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

Target follow-up type

Weeks

Description of intervention(s) / exposure

Inspiratory muscle weakness measured prior to cardiovascular surgery
Presence of post-operative pulmonary complications in the 1 week following cardiac surgery.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Inspiratory muscle weakness measured in cmH2O.

This observational study of elective cardiac surgery patients will involve measuring maximum inspiratory pressure (MIP) at the pre-admission clinic visit. This MIP measurement is a straight-forward procedure that can be completed
by the pre-admission nurse and/ or physiotherapist using a hand-held device (MicroRPM machine and disposable filter). Briefly, the participant will be instructed to exhale to residual volume (they will be instructed to "empty their lungs"), then close their lips around a mouthpiece connected to a respiratory pressure meter, and then maximally inhale for at least 1 second. In accordance with established guidelines for respiratory measurement, they will repeat this manoeuvre 3 times, and best result will be recorded as their MIP. This allows for any learning effects or fatigue effects which may affect measurement. The total duration of testing will take less than 5 minutes. The researchers have extensive experience with this technique.

Timepoint [1]

Pre-operative appointment prior to elective cardiac surgery, usually between 2 and 6 weeks prior to surgery date.

Secondary outcome [1]

Prevalence of post-operative pulmonary complications (PPCs) as defined by the Melbourne Group Criteria.

PPCs include atelectasis , pneumonia, pleural effusion, pulmonary oedema, respiratory failure, pneumothorax and others.

We will scrutinise the patients' medical records to determine whether PPCs have occurred. This will involve a manual trawl of medical records at the hospital, and categorisation of PPCs according to the predefined criteria of the Melbourne Group Scale (Version 2):
Diagnosis will be confirmed when four or more of the following are present:
• Chest radiograph report of consolidation/collapse
• Raised temperature >38 ?C on two or more consecutive days
• SpO2 <90% on room air on two consecutive days
• Production of yellow or green sputum which is different to pre-operative assessment
• An otherwise unexplained white cell count >11 × 109 L-1 or prescription of an antibiotic specific for respiratory infection
• Physician diagnosis of chest infection
• Presence of infection on sputum culture report
• Abnormal breath sounds on auscultation which differ from pre-operative assessment

Timepoint [1]

1 week following elective cardiac surgery

Eligibility

Key inclusion criteria

Patients presenting at the pre-admission clinic for assessment prior to elective cardiac surgery (e.g. coronary artery bypass grafting, valve replacements, or any other major open cardiac surgery via sternotomy).

Must be able to follow instructions and provide informed written consent.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients will be excluded if they cannot provide informed written consent (eg due to physical or intellectual disability).
Patients with recent lung surgery, a known pneumothorax, or an inability to maintain a lip seal on the assessment device will also be excluded.

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

Data will be stored securely on a password protected computer throughout the project, and then stored at the University of Canberra for the required five-year period after which it will be destroyed according to university protocols. Data will be identifiable in the collection phase only, using hospital medical record numbers to ensure
accuracy and avoid duplication. Once data collection is complete, the data will be stored in a deidentified manner only, using study numbers instead of medical record numbers.

Demographic and inspiratory muscle strength (MIP) data will be analysed descriptively. We will then use regression analysis to determine whether any pre-operative factors were associated with prevalence of PPCs, and in particular whether MIP was
associated with PPCs in any way.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

31/08/2018

Actual

31/08/2018

Date of last participant enrolment

Anticipated

31/12/2018

Actual

30/06/2019

Date of last data collection

Anticipated

30/06/2019

Actual

30/06/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT

Recruitment hospital [1]

National Capital Private Hospital - Garran

Recruitment postcode(s) [1]

2605 - Garran

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Canberra

Address [1]

University Drive
Bruce ACT 2617

Country [1]

Australia

Primary sponsor type

University

Name

University of Canberra

Address

University Drive
Bruce ACT 2617

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Canberra Human Research Ethics Committee

Ethics committee address [1]

University Drive
Bruce ACT 2617

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/07/2018

Approval date [1]

08/08/2018

Ethics approval number [1]

20180387

Summary

Brief summary

Emerging evidence indicates that elective cardiac surgery patients may benefit from inspiratory muscle training (targeted strengthening of the respiratory muscles) to reduce the incidence of post-operative pulmonary complications (PPCs). However, little is known about the baseline (pre-operative) inspiratory muscle strength of patients undergoing elective cardiac surgery. It is unlikely that every patient requires inspiratory muscle training,and it would be helpful to clarify the proportion of patients who are likely to benefit from such training. This can be easily done through measuring their inspiratory muscle strength pre-operatively as part of their preparation for surgery. However, such measurement is not yet standard practice.

We hypothesise that the prevalence of inspiratory muscle weakness may be 30% or greater in a cohort of patients preparing for elective cardiac surgery.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Bernie Bissett

Address

12D44 University of Canberra
University Drive, Bruce ACT 2617

Country

Australia

Phone

+61 404319234

Fax

Bernie.Bissett@canberra.edu.au

Contact person for public queries

Name

Bernie Bissett

Address

12D44 University of Canberra
University Drive, Bruce ACT 2617

Country

Australia

Phone

+61 404319234

Fax

Bernie.Bissett@canberra.edu.au

Contact person for scientific queries

Name

Bernie Bissett

Address

12D44 University of Canberra
University Drive, Bruce ACT 2617

Country

Australia

Phone

+61 404319234

Fax

Bernie.Bissett@canberra.edu.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

Ethical clearance does not include patient data sharing

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

Source	Title	Year of Publication	DOI
Embase	What is the prevalence of inspiratory muscle weakness in preoperative cardiac surgery patients? An observational study.	2020	https://dx.doi.org/10.1016/j.hrtlng.2020.06.012

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically