The SPIRO-MOTE Study NCT05960344

Updated 05/31/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT05960344
Other study ID #	SCH-2539
Secondary ID
Status	Completed
Phase
First received
Last updated
Start date	February 24, 2021
Est. completion date	May 31, 2022

Study information
Verified date	July 2023
Source	Sheffield Children's NHS Foundation Trust
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status	Completed
Enrollment	40
Est. completion date	May 31, 2022
Est. primary completion date	May 31, 2022
Accepts healthy volunteers
Gender	All
Age group	5 Years to 16 Years
Eligibility	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

Related Conditions & MeSH terms

Spirometry

Intervention

Procedure:
• Spirometry
Supervised v unsupervised spirometry

Locations
Country	Name	City	State
United Kingdom	Clinical Research Facility, Sheffield Children's Hospital	Sheffield

Sponsors *(1)*
Lead Sponsor	Collaborator
Sheffield Children's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Outcome measures from spirometry tests (1)	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.	Within two weeks
Primary	Outcome measures from spirometry tests (2)	The team will record how many patients achieved technically acceptable tests, using the ATS A-F standards (9), and how many failed.	Within two weeks
Primary	Length of each standard test	Researchers will record how long each standard test took to carry out.	Within two weeks

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