Validation of an Artificial Intelligence Enabled Diagnostic Support Software (ArtiQ.Spiro) in Primary Care Spirometry Datasets - a Retrospective Analysis

NCT05648227 | Active Not Recruiting

• 1 other identifier: 314058
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

A retrospective study to evaluate the diagnostic performance of an Artificial Intelligence enabled software (ArtiQ.Spiro) in UK primary care spirometry datasets.

Conditions

Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• Evaluate diagnostic performance of an Artificial Intelligence enabled software (ArtiQ.Spiro) in UK primary care spirometry datasets.

  Evaluate diagnostic performance of an Artificial Intelligence enabled software (ArtiQ.Spiro) in UK care spirometry datasets.

  24 months

Secondary Outcomes (1)

• To evaluate the performance of an Artificial Intelligence enabled software (ArtiQ.Spiro) in the quality grading of Forced Expiratory Volume in One second (FEV1) and Forced Vital Capacity (FVC) from UK primary care spirometry datasets.

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The datasets, which will be analysed retrospectively, will comprise spirometry data previously collected as part of clinical spirometry pathways in primary care.

You may qualify if:

• Adult aged 18 years or over
• At least one of the following respiratory symptoms: cough, wheeze, shortness of breath, reduced exercise tolerance
• Spirometry performed for clinical purposes in a non-hospital lung function setting (such as a community clinic, a GP practice, or at home)
• Spirometry was supervised by a doctor or non-medical allied health professional

You may not qualify if:

• Aged 17 or under
• No respiratory symptoms
• Spirometry performed for pre-operative assessment
• Spirometry performed exclusively as part of a research study
• Spirometry performed at home without supervision.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• The Hillingdon Hospitals NHS Foundation Trust: collaborator
• University of Leicester: collaborator
• Southern Health NHS Foundation Trust: collaborator
• Imperial College London: collaborator
• Queen Mary University of London: collaborator
• King's College London: collaborator
• Papworth Hospital NHS Foundation Trust: collaborator
• King's College Hospital NHS Trust: collaborator

Study Sites (1)

Harefield Hospital

Middlesex, UB9 6JH, United Kingdom

Location

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• William Man, FRCP

  Royal Brompton & Harefield Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: July 1, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 28, 2025
• Last Updated: January 31, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)