Aerosolisation During Respiratory Procedures

February 10, 2021 updated by: Guy's and St Thomas' NHS Foundation Trust

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy subjects

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterisation of aerosolised respiratory droplets
Time Frame: 1 year
Performed using high-speed imaging and particle size counters
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 3, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 288629

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Anonymised data may be shared based upon consideration of reasonable requests from researchers with a stated objective.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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