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NCT04741217 Clinical Trial

Aerosolisation During Respiratory Procedures

Healthy Clinical Trial

Official title:
A Proof of Concept Study to Evaluate Aerosol Generation During Non-Invasive Positive Pressure Respiratory Procedures

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04741217
Other study ID # 288629
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date September 1, 2021

Study information
Verified date August 2020
Source Guy's and St Thomas' NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Currently, a major issue within respiratory medicine is undertaking procedures that generate aerosolisation with the concern of spreading infection, such as the SARS-COV-2/COVID-19 virus. It is anecdotally reported that lung function testing and positive airways pressure devices used in clinical practice are aerosol generating procedures however the data to support this is limited. With the advent of high-speed imaging systems that can capture and quantify particle size and velocity we aim to investigate the aerosol generation in routine non-invasive positive pressure respiratory procedures.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date September 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Age 18-80 years - Healthy subjects with no active medical conditions or previous pneumothorax - Cognitively and linguistically able to follow instructions given in English and provide informed consent Exclusion Criteria: - Significant respiratory, cardiac or neurological conditions or previous pneumothorax - Smoking history greater than 10 pack years - Acute illness at the time of assessment - Allergies to latex, metals or local anaesthetic agents

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Not an interventional study
No interventions are implemented. This is an observational study of respiratory droplet aerosolisation during respiratory procedures.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust

Outcome
Type Measure Description Time frame Safety issue
Primary Characterisation of aerosolised respiratory droplets Performed using high-speed imaging and particle size counters 1 year
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