Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 620 for:    oximeter

Development of a Robust and Reliable Pulse Oximeter for Children With Pneumonia in Low-income Countries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02941237
Recruitment Status : Unknown
Verified October 2016 by Isabeau Walker, Great Ormond Street Hospital for Children NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : October 21, 2016
Last Update Posted : October 24, 2016
Sponsor:
Collaborators:
Johns Hopkins University
University College, London
PACHI Malawi – Parent and Child Health Initiative Trust
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Isabeau Walker, Great Ormond Street Hospital for Children NHS Foundation Trust

Brief Summary:
This study is to test the usability of a new pulse oximeter probe designed for children 0-5 years.

Condition or disease Intervention/treatment Phase
Pneumonia in Children Measurement of Peripheral Oxygen Saturation Device: Pulse oximeter Not Applicable

Detailed Description:

Pneumonia is the leading infectious cause of death in children under five. World Health Organization guidelines recommend measurement of peripheral oxygen saturation (SpO2) in children with pneumonia to guide treatment. This project focuses on the design of a new 'Lifebox' pulse oximeter probe for use in children 0-5 years of age.

A new oximeter probe compatible with the Lifebox oximeter has been designed to be used for children 0-5 years in all settings.

The aims of the study are to:

  1. to evaluate the usability of the redesigned Lifebox oximeter probe by an expert user
  2. to evaluate the usability of the redesigned oximeter probe by trained healthcare workers, against defined product specifications.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Development of a Robust and Reliable Pulse Oximeter for Use by Frontline Healthcare Providers Caring for Children With Pneumonia in Low-income Countries
Study Start Date : December 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Healthcare worker measurement of SpO2
Measurement of SpO2 using the Lifebox pulse oximeter probe in children of different ages, stratified by age: 0-1 months, 2-11 months, 12-23 months and 24-59 months
Device: Pulse oximeter

Time taken to measure oxygen saturation.

Completion of usability questionnaire


Expert measurement of SpO2
Measurement of SpO2 using the Lifebox pulse oximeter probe in children of different ages, stratified by age: 0-1 months, 2-11 months, 12-23 months and 24-59 months
Device: Pulse oximeter

Time taken to measure oxygen saturation.

Completion of usability questionnaire





Primary Outcome Measures :
  1. Time to obtain SpO2 reading [ Time Frame: Through completion of study, average one hour ]
    The time to obtain a stable reading will be declared by the healthcare worker and noted by the independent observer, to give a proportion fulfilling the Target Product Profile (TPP).


Other Outcome Measures:
  1. Usability questionnaire [ Time Frame: Through study completion, average one hour ]
    Healthcare workers and the expert user will complete a usability questionnaire after completion of readings in children of different ages



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patient participants:

  • Inpatients (or child awaiting surgery on pre-operative ward) in Great Ormond Street Hospital
  • Aged 0 - 59 months
  • Clinically stable (as judged by the ward sister and medical team)
  • Parent (or adult with parental responsibility) present
  • Written informed consent from the parent (or adult with parental responsibility)

Healthcare worker participants:

  • Nursing staff employed at Great Ormond Street Hospital who are trained in the use of pulse oximetry
  • Written informed consent from the healthcare worker

Exclusion Criteria:

Patient participants:

  • Unstable or critically unwell patients (as judged by the ward sister and medical team)
  • Parents (or adult with parental responsibility) who are not able or willing to give informed consent
  • Parents (or adult with parental responsibility) unable to speak English well enough to understand study methods or consent form
  • For part of the study assessing usability of the probe by healthcare workers, patients with oxygen saturation 95% or below will be excluded

Healthcare worker participants:

  • Nursing staff who are not trained to use a pulse oximeter
  • Nursing staff who have not given written informed consent

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): NCT02941237


Contacts
Layout table for location contacts
Contact: Isabeau A Walker, FRCA +44 207 405 9200 ext 8865 isabeau.walker@gosh.nhs.uk
Contact: Nicholas Boyd, FRCA +44 207 405 9200 ext 8865 nicholas.boyd@gosh.nhs.uk

Locations
Layout table for location information
United Kingdom
Great Ormond Street Hospital NHS Foundation Trust Not yet recruiting
London, United Kingdom, WC1N 3JH
Contact: Isabeau A Walker, FRCA    0207 2074059200 ext 8865    isabeau.walker@gosh.nhs.uk   
Contact: Nicholas Boyd, FRCA    0207 4059200 ext 8865    nicholas.boyd@gosh.nhs.uk   
Principal Investigator: Isabeau A Walker, FRCA         
Sub-Investigator: Nicholas Boyd, FRCA         
Sponsors and Collaborators
The Lifebox Foundation
Johns Hopkins University
University College, London
PACHI Malawi – Parent and Child Health Initiative Trust
Bill and Melinda Gates Foundation
Investigators
Layout table for investigator information
Principal Investigator: Isabeau A Walker, FRCA Great Ormond Street Hospital NHS Foundation Trust

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Isabeau Walker, Consultant Paediatric Anaesthetist, Honorary Senior Lecturer, Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02941237     History of Changes
Other Study ID Numbers: OPP1133291
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Yes. De-identified individual participant data for all primary and secondary outcomes will be made available for all study participants within 6 months of study completion
Keywords provided by Isabeau Walker, Great Ormond Street Hospital for Children NHS Foundation Trust:
Pulse oximetry
Children
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections