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Paediatric Oximetry Algorithms - Normative Data Collection

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ClinicalTrials.gov Identifier: NCT03823326
Recruitment Status : Completed
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Sheffield Children's NHS Foundation Trust

Study Description
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Brief Summary:
To undertake normative data collection of existing clinical algorithms using existing oximetry technology.

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Paediatric Oximetry Algorithms - Normative Data Collection
Actual Study Start Date : May 26, 2017
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 16 Years   (Child)
Sexes 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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823326


Locations
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United Kingdom
Clinical Research Facility
Sheffield, South Yorkshire, United Kingdom, S10 2TH
Sponsors and Collaborators
Sheffield Children's NHS Foundation Trust
Investigators
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Principal Investigator: Heather E Elphick, MbChBMDMRCPH Sheffield Children's Hospital
More Information
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Responsible Party: Sheffield Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03823326    
Other Study ID Numbers: SCH-2155
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases