Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001237875
Ethics application status
Approved
Date submitted
16/07/2021
Date registered
13/09/2021
Date last updated
13/09/2021
Date data sharing statement initially provided
13/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Spread of Aerosols During Respiratory Manoeuvres and During Administration of Respiratory Support in Patients with Respiratory Disease and Healthy Volunteers
Scientific title
The Spread of Aerosols During Respiratory Manoeuvres and During Administration of Respiratory Support in Patients with Respiratory Disease and Healthy Volunteers
Secondary ID [1] 304796 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airborne viral transmission via respiratory aerosols 322863 0
Condition category
Condition code
Respiratory 320439 320439 0 0
Other respiratory disorders / diseases
Public Health 320440 320440 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants are required to attend a testing session involving the administration of respiratory support via Nasal prong Oxygen, High-flow nasal cannula, and continuous positive airway pressure (CPAP) mask as would be standard care for respiratory disease patients in the respiratory ward of the hospital. Participants will be required to talk quietly and simulate coughing during aerosol measurements around the perimeter of the patient's bed.

Study Design:
Participants will visit the laboratory for a single session, with the visit length lasting between 1.5-2.5 hours. Testing will be performed in one single session and no follow-up is required. We will measure respiratory aerosol spread during different respiratory manoeuvres and with different breathing support strategies in healthy participants to confirm study feasibility, followed by hospitalised patients with non-infective pulmonary pathology.

Healthy participants will have measurements made during quiet tidal breathing, cough, talking, spirometry (with and without filter), nebuliser with saline, and continuous positive airway pressure (with and without a mask leak). All testing procedures for healthy controls will be performed at the Woolcock Institute of Medical Research. Safety protocols and training are in practice to avoid viral transmission, and all investigators will undergo compulsory research training on how to test patients safely during the global pandemic. Investigators and study personnel are currently required to wear gloves, gowns and a facemask during the testing procedures and at any time that close contact is required with participants. The required PPE for investigators and safe lung function testing will be adapted to keep up with NSW health Guidelines.

Hospitalised patients will be split into two groups in order to reduce the burden of testing (n=16/group). These two groups will perform different respiratory manoeuvres and be fitted with different respiratory support as follows:

Group 1 will have measurements of aerosol production during quiet tidal breathing, cough, talking, Continuous Positive Airway Pressure (CPAP)(with and without a mask leak). Each test will take 10-15 minutes to measure aerosol at each grid point around the patients’ bed.

Group 2 will have measurements of aerosol production during quiet tidal breathing, oxygen administration with high flow nasal cannula (HFNC), oxygen administration with nasal prongs, and nebulised saline administration. Each test will take 10-15 minutes to measure aerosol at each grid point around the patients’ bed.

Administration of respiratory support will be performed by either Prof Greg King, Dr Jack T Callum, Dr David G Chapman or Dr Jack Bozier, and aerosol measurements will be taken by Dr Jack Bozier.
Intervention code [1] 321171 0
Early Detection / Screening
Comparator / control treatment
Aerosol spread during talking/breathing room air used as a comparator to aerosol spread during the administration of respiratory support.

Tests will be performed by healthy control participants to confirm study feasibility, followed by respiratory disease participants to determine aerosol spread in the clinical setting under normal clinical conditions (i.e. administration of common respiratory support measures to patients who would typically receive it during normal clinical procedure).
Control group
Active

Outcomes
Primary outcome [1] 328279 0
The total number of particles in room air during common respiratory manoeuvres and administration of breathing support in both healthy and diseased participants will be measured using an optical particle sizer (OPS) and high-resolution electrical low-pressure impactor (HR-ELPI)
Timepoint [1] 328279 0
During the administration of respiratory support measured over a period of 15 minutes of respiratory support or common respiratory manoeuvres
Secondary outcome [1] 398329 0
Size distribution of particles in room air during common respiratory manoeuvres and administration of breathing support in both healthy and diseased participants will be measured using an optical particle sizer (OPS) and high-resolution electrical low-pressure impactor (HR-ELPI)
Timepoint [1] 398329 0
During the administration of respiratory support measured over a period of 15 minutes of respiratory support or common respiratory manoeuvres.

Eligibility
Key inclusion criteria
Healthy Participants
Subjects recruited will have normal lung function with no underlying physician-diagnosed respiratory disease and satisfy the following criteria:
• Non-smoker with pack years < 10 years
• BMI < 30kg/m3

Respiratory Disease Patients
Subjects recruited will be admitted to RNSH with resolved infective pulmonary pathology, or attending outpatient clinics with physician-diagnosed respiratory disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Healthy Participants
• No Intensive Care Unit admissions in the last 12 months.
• Active or chronic respiratory pathologies (for example, interstitial lung disease, asthma, chest wall pathology causing ventilatory restriction)
• History of lung surgery (including lobectomy or pneumonectomy, but not lung biopsy) or thoracic radiation therapy (excluding isolated mediastinal radiation therapy with no evidence of subsequent pulmonary fibrosis)
• Any major comorbidities deemed to impact on respiratory physiology or symptoms, including severe on uncontrolled heart failure, morbid obesity (BMI >40), muscular or neurological disorders causing respiratory muscle weakness or dysfunctional swallowing
• History of chronic kidney disease (creatine greater than the upper limit of normal)
• Unable to perform lung function testing
• Women who are breast feeding, pregnant, or unwilling to avoid pregnancy during the study period
• Unable to provide informed consent

Respiratory Disease Patients
• Unable to perform lung function testing
• Serious comorbidities that put the patient at risk when performing spirometry or during the administration of breathing support
• Unable to provide informed consent
• Known infective Tuberculosis, viral respiratory infection, or HIV.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/10/2021
Actual
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
11/02/2022
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309168 0
Commercial sector/Industry
Name [1] 309168 0
GlaxoSmithKline
Country [1] 309168 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
431 Glebe Point Road, Glebe, NSW, 2037
Country
Australia
Secondary sponsor category [1] 310349 0
None
Name [1] 310349 0
Address [1] 310349 0
Country [1] 310349 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309030 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 309030 0
Ethics committee country [1] 309030 0
Australia
Date submitted for ethics approval [1] 309030 0
27/11/2020
Approval date [1] 309030 0
03/12/2020
Ethics approval number [1] 309030 0
2020/ETH02786

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

Contacts
Principal investigator
Name 112710 0
Prof Gregory King
Address 112710 0
Woolcock Institute of Medical Research, 431 Glebe Point Road, Glebe, NSW, 2037
Country 112710 0
Australia
Phone 112710 0
+61299140413
Fax 112710 0
Email 112710 0
[email protected]
Contact person for public queries
Name 112711 0
Jack Bozier
Address 112711 0
Woolcock Institute of Medical Research, 431 Glebe Point Road, Glebe, NSW, 2037
Country 112711 0
Australia
Phone 112711 0
+61416753275
Fax 112711 0
Email 112711 0
[email protected]
Contact person for scientific queries
Name 112712 0
Jack Bozier
Address 112712 0
Woolcock Institute of Medical Research, 431 Glebe Point Road, Glebe, NSW, 2037
Country 112712 0
Australia
Phone 112712 0
+61416753275
Fax 112712 0
Email 112712 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


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.