The SPIRO-MOTE Study

NCT05960344 | Completed

• 1 other identifier: SCH-2539
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spirometry

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Length of each standard test

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

  Within two weeks

Interventions

Spirometry PROCEDURE

Supervised v unsupervised spirometry

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited at the four participating centres: Sheffield Children's Hospital, Leeds Children's Hospital, Royal Hospital for Children (Glasgow) and Great Ormond Street Hospital (London).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead

Study Sites (1)

Clinical Research Facility, Sheffield Children's Hospital

Sheffield, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Heather Elphick

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: July 25, 2023
• Study Start: February 24, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)