Paediatric Oximetry Algorithms - Normative Data Collection

To undertake normative data collection of existing clinical algorithms using existing oximetry technology.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes in Children

Detailed Description

Paediatric patients who are undergoing routine diagnostic pulse oximetry, will be approached to also wear an additional oximeter at the same time so that comparisons between two oximeters and their clinical algorithms can be compared.

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2TH
      • Clinical Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 16 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All children aged 1 month - 16 years who are undergoing an overnight pulse oximetry investigation.

Description

Inclusion Criteria:

• All children who have been referred for a clinical overnight pulse oximetry test

Exclusion Criteria:

• Families who do not understand written English if an interpreter is not present for clinical reasons
• Times when the kit is already being used for another recruit
• If children do not attend with the legal guardian and so informed consent cannot be signed
• Patient is deemed too unwell by clinical team to be approached about the research

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oximetry Raw data	2 second data dumps of SpO2 signals from an overnight trace	Overnight (8-10 hours) of pulse oximetry data is collected from participants and then they have completed the study. It is a single time frame of data collection.
Pulse Rate Raw data	2 second data dumps of SpO2 signals from an overnight trace	Overnight (8-10 hours) of pulse oximetry data is collected from participants and then they have completed the study. It is a single time frame of data collection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age of child at time of oximetry	Taken at time of consent
Gender	Gender of child	Taken at time of consent

Collaborators and Investigators

• Sponsor: Sheffield Children's NHS Foundation Trust
• Investigators: Principal Investigator: Heather E Elphick, MbChBMDMRCPH, Sheffield Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2017
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: SCH-2155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No