Paediatric Oximetry Algorithms - Normative Data Collection

Sleep Apnea Syndromes in Children Clinical Trial

Official title:

Paediatric Oximetry Algorithms - Normative Data Collection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823326
• Other study ID #: SCH-2155
• Status: Completed
• Start date: May 26, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: January 2019
• Source: Sheffield Children's NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Gender: All
• Age group: 1 Month to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea Syndromes in Children

Locations

Country	Name	City	State
United Kingdom	Clinical Research Facility	Sheffield	South Yorkshire

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
Other	Age	Age of child at time of oximetry	Taken at time of consent
Other	Gender	Gender of child	Taken at time of consent
Primary	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.
Primary	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