The SPIRO-MOTE Study

Completed

• Conditions: Spirometry

• Registration Number: NCT05960344
• Lead Sponsor: Sheffield Children's NHS Foundation Trust

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-24
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Study First Submitted: 2023-04-19
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-21
• Last Update Submitted: 2023-07-21
• Study First Posted: 2023-07-25
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome measures from spirometry tests (1)	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	Within two weeks	Researchers will record how long each standard test took to carry out.
Outcome measures from spirometry tests (2)	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.

Trial Locations

Locations (1)

Clinical Research Facility, Sheffield Children's Hospital; 🇬🇧 Sheffield, United Kingdom