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The SPIRO-MOTE Study

Sponsor
Sheffield Children's NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT05960344
Collaborator
(none)
40
Enrollment
1
Location
15.1
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Spirometry

Study Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: Validation and Comparison of Supervised and Unsupervised Spirometry
Actual Study Start Date :
Feb 24, 2021
Actual Primary Completion Date :
May 31, 2022
Actual Study Completion Date :
May 31, 2022

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. Length of each standard test [Within two weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 16 Years
Sexes Eligible for Study:
All
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Research Facility, Sheffield Children's Hospital Sheffield United Kingdom

Sponsors and Collaborators

  • Sheffield Children's NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heather Elphick, Professor Heather Elphick, Sheffield Children's NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT05960344
Other Study ID Numbers:
  • SCH-2539
First Posted:
Jul 25, 2023
Last Update Posted:
Jul 25, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 25, 2023