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The Spread of Aerosols During Respiratory Manoeuvres and During Administration of Respiratory Support in Patients with Respiratory Disease and Healthy Volunteers

The Spread of Aerosols During Respiratory Manoeuvres and During Administration of Respiratory Support in Patients with Respiratory Disease and Healthy Volunteers

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621001237875
Enrollment
42
Registered
2021-09-13
Start date
2021-10-18
Completion date
2021-12-31
Last updated
2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

When hospitalised, patients with infective pulmonology often require some form of breathing support: oxygen administered using different delivery modes (nasal prongs, high flow nasal cannula, The currently limited data suggests that each of these strategies increase the spread of exhaled droplets, with the distance and direction-dependent upon the specific strategy, resulting in an increased viral transmission risk if this patient is still infective. Therefore, it is necessary to determine droplet spread from human patients with each of the respiratory support strategies administered to patients with a viral infection, so that protective measures can be adapted accordingly to protect staff and other patients in the hospital. We hypothesise that the administration of respiratory support will increase the number of detected respiratory aerosol particles detected around the study subject.

Interventions

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

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.

Sponsors

Woolcock Institute of Medical Research
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026