The SPIRO-MOTE Study

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

Completed

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Key information

Conditions

Spirometry

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Research Facility, Sheffield Children's Hospital

Sheffield, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Spirometry

Procedure

Supervised v unsupervised spirometry

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.
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.
Length of each standard test

Time frame: Within two weeks

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

Sponsors and collaborators

Lead sponsor

Sheffield Children's NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jul 25, 2023
Registry last updated: Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed