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OpenTrials
Completed

NCT Number: NCT03823326

Paediatric Oximetry Algorithms - Normative Data Collection

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

Completed

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Key information

Conditions

Sleep Apnea Syndromes in Children

Age range

1 month–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Research Facility

Sheffield, South Yorkshire, S10 2TH, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Oximetry Raw data

    Time frame: 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.

    2 second data dumps of SpO2 signals from an overnight trace

  2. Pulse Rate Raw data

    Time frame: 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

    2 second data dumps of SpO2 signals from an overnight trace

Other outcomes

  1. Age

    Time frame: Taken at time of consent

    Age of child at time of oximetry

  2. Gender

    Time frame: Taken at time of consent

    Gender of child

Sponsors and collaborators

Lead sponsor

Sheffield Children's NHS Foundation Trust

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2019
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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