Aerosolisation During Respiratory Procedures

• Sponsor: Guy's and St Thomas' NHS Foundation Trust (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04741217
• Collaborator: (none)
• Enrollment: 10
• Anticipated Duration (Months): 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Respiratory Tract Infections; Lung Infection; Droplet Spread	Other: Not an interventional study

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Proof of Concept Study to Evaluate Aerosol Generation During Non-Invasive Positive Pressure Respiratory Procedures
• Anticipated Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Sep 1, 2021

Outcome Measures

Primary Outcome Measures

1. Characterisation of aerosolised respiratory droplets [1 year]

   Performed using high-speed imaging and particle size counters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Guy's and St Thomas' NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guy's and St Thomas' NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT04741217
• Other Study ID Numbers: 288629
• First Posted: Feb 5, 2021
• Last Update Posted: Feb 15, 2021
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections

Study Results

No Results Posted as of Feb 15, 2021