NCT04741217

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 15, 2021

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

February 3, 2021

Last Update Submit

February 10, 2021

Conditions

HealthyRespiratory Tract InfectionsLung InfectionDroplet Spread

Outcome Measures

Primary Outcomes (1)

  • Characterisation of aerosolised respiratory droplets

    Performed using high-speed imaging and particle size counters

    1 year

Interventions

Not an interventional studyOTHER

No interventions are implemented. This is an observational study of respiratory droplet aerosolisation during respiratory procedures.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 5, 2021

Study Start

March 1, 2021

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

February 15, 2021

Record last verified: 2020-08