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Clinical Trials/NCT05960344
NCT05960344
Completed
Not Applicable

Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: Validation and Comparison of Supervised and Unsupervised Spirometry

Sheffield Children's NHS Foundation Trust1 site in 1 country40 target enrollmentFebruary 24, 2021
ConditionsSpirometry

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spirometry
Sponsor
Sheffield Children's NHS Foundation Trust
Enrollment
40
Locations
1
Primary Endpoint
Outcome measures from spirometry tests (1)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: validation and comparison of supervised and unsupervised spirometry

Registry
clinicaltrials.gov
Start Date
February 24, 2021
End Date
May 31, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heather Elphick

Professor Heather Elphick

Sheffield Children's NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

  • Male and female children aged 5 to 16 years old
  • Doctor diagnosed respiratory condition, including asthma, cystic fibrosis, PCD, bronchiectasis
  • Child able to perform reliable spirometry
  • Family have access to a smartphone or tablet and a second device for video consultation

Exclusion Criteria

  • Significant learning difficulties
  • Other reasons for being unable to do lung function tests, for example, unable to make a seal around the mouthpiece
  • Informed consent/assent has not been provided
  • No English speaking member of the family
  • Contraindications as outlined by the ARTP, e.g. pneumothorax, haemoptysis of unknown origin, unstable cardiovascular status, recent eye surgery, vomiting or any acute disease that would interfere with the test performance, recent surgery (thoracic/abdominal)

Outcomes

Primary Outcomes

Outcome measures from spirometry tests (1)

Time Frame: Within two weeks

The researchers will use the absolute values for FEV1 and FVC, coupled with the demographic data, to calculate FEV1/FVC, percent predicted and z-scores using a batch calculator from the GLI website. The team will record how many patients achieved technically acceptable tests, using the ATS A-F standards (9), and how many failed.

Length of each standard test

Time Frame: Within two weeks

Researchers will record how long each standard test took to carry out.

Outcome measures from spirometry tests (2)

Time Frame: Within two weeks

The team will record how many patients achieved technically acceptable tests, using the ATS A-F standards (9), and how many failed.

Study Sites (1)

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