Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001087640p
Ethics application status
Submitted, not yet approved
Date submitted
2/06/2023
Date registered
17/10/2023
Date last updated
17/10/2023
Date data sharing statement initially provided
17/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Predicting aspiration pneumonia.
Scientific title
Risk estimation for aspiration pneumonia from known physiological risk factors.
Secondary ID [1] 309818 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aspiration pneumonia 330235 0
Condition category
Condition code
Respiratory 327106 327106 0 0
Other respiratory disorders / diseases
Infection 327312 327312 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Risk factors for the development of aspiration pneumonia will be analyzed. Physiological data taken from all participants will include measures of voluntary and induced cough strength, swallowing-respiratory coordination and indices of oral health (breath analysis). In addition to this, collection of key information from participant medical records will be recorded. Participant involvement will entail approximately 40 minutes of time during one data collection session with a follow-up five minute telephone call three months later for some participants.

We have a prototype device that measures swallowing-respiratory coordination, cough strength and oral health.
Intervention code [1] 326251 0
Not applicable
Comparator / control treatment

Healthy age- and gender-matched (where possible) individuals and patients.

Data collection will involve up to 40 minutes of participant time.
Healthy participants will be required to complete a short questionnaire.
Both healthy and patient participants will be asked to breathe into the measurement device whereupon measures of swallowing-respiratory coordination, voluntary cough strength and analysis of breath will be taken. Finally, participants will be required to complete a cough reflex test.
Control group
Active

Outcomes
Primary outcome [1] 334967 0
Swallowing-respiratory coordination will be measured using a prototype device.

Timepoint [1] 334967 0
At a single data collection visit.
Primary outcome [2] 334968 0
Cough strength: voluntary and induced will be measured using a prototype device.
Timepoint [2] 334968 0
At single data collection visit
Primary outcome [3] 335173 0
Oral health will be measured using a prototype device.
Timepoint [3] 335173 0
At single data collection visit
Secondary outcome [1] 422593 0
Aspiration pneumonia diagnosis will be ascertained through medical records/phone call for patients and by a follow up phone call for healthy participants.
Timepoint [1] 422593 0
3 months post data collection visit.

Eligibility
Key inclusion criteria
Patients:
Referred to clinicians (e.g. Speech & Language Pathologists) in the Health New Zealand Canterbury region.
Able to provide informed consent in isolation or with support of family, friends, and whanau (supported consent).
Able to undertake a citric acid cough reflex test (see exclusions below).

Healthy aged-matched individuals
Able to provide informed consent in isolation or with support of family, friends, and whanau (supported consent).
Able to undertake a citric acid cough reflex test (see exclusions below).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient exclusion criteria
Has a stoma or tracheostomy tube.
Is unable to take a cough reflex test.
Current diagnosis of pneumonia
Has any facial injuries, such as wounds, abrasions, skin allergies or bruising.
Has excessive ear wax or other foreign material in ears, an ear infection or inflammation, swelling, or pain in the ear canal.

Healthy aged-matched and gender matched individual criteria
As per patient exclusion criteria with the addition of:
Has a significant disorder, disease, structural or medical abnormality, or injury affecting swallowing or respiration.
Has a neurological condition.
Has had an upper respiratory tract infection within the last two weeks.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis
A cluster analysis will be performed to determine characteristics of an unspecified number of groups encompassing the patient and healthy aged-matched individual sample. A sample size of 80 was estimated based on four outcome variables.

Feature extraction for the purposes of inputting to a machine learning model will be conducted in an exploratory fashion and as such it is not possible to definitively list all the measures that will be extracted from the data.

Each participant’s aspiration pneumonia status following data collection will be used as the ‘ground-truth’ data to provide labelled data for training and testing of the predictive model. These features will be used to train different machine learning models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 25575 0
New Zealand
State/province [1] 25575 0
Canterbury

Funding & Sponsors
Funding source category [1] 314003 0
University
Name [1] 314003 0
University of Canterbury Rose Centre for Stroke Recovery & Research
Country [1] 314003 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
University of Canterbury20 Kirkwood AvenueUpper Riccarton, Christchurch8041
Country
New Zealand
Secondary sponsor category [1] 315888 0
None
Name [1] 315888 0
Address [1] 315888 0
Country [1] 315888 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313141 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 313141 0
Postal address:Ministry of HealthHealth and Disability Ethics CommitteesPO Box 5013Wellington 6140Street address:133 Molesworth StreetThorndonWellington 6011
Ethics committee country [1] 313141 0
New Zealand
Date submitted for ethics approval [1] 313141 0
25/07/2023
Approval date [1] 313141 0
Ethics approval number [1] 313141 0

Summary
Brief summary
This study will identify whether physiological data collected with clinical information can be used to predict the development of aspiration pneumonia. Additionally, we hypothesize that this information can be used to train a machine learning system for predicting a patient’s risk of developing aspiration pneumonia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127130 0
Miss Laura Strevens
Address 127130 0
University of Canterbury Rose Centre for Stroke Recovery and ResearchSt George's Health Centre249 Papanui RoadStrowan 8041Christchurch.
Country 127130 0
New Zealand
Phone 127130 0
+64 3 369 2385
Fax 127130 0
Email 127130 0
laura.strevens@pg.canterbury.ac.nz
Contact person for public queries
Name 127131 0
Miss Laura Strevens
Address 127131 0
University of Canterbury Rose Centre for Stroke Recovery and ResearchSt George's Health Centre249 Papanui RoadStrowan 8041Christchurch.
Country 127131 0
New Zealand
Phone 127131 0
+64 3 369 2385
Fax 127131 0
Email 127131 0
laura.strevens@pg.canterbury.ac.nz
Contact person for scientific queries
Name 127132 0
Miss Laura Strevens
Address 127132 0
University of Canterbury Rose Centre for Stroke Recovery and ResearchSt George's Health Centre249 Papanui RoadStrowan 8041Christchurch.
Country 127132 0
New Zealand
Phone 127132 0
+64 3 369 2385
Fax 127132 0
Email 127132 0
laura.strevens@pg.canterbury.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is embargoed due to potential commercial potential of device.


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.