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Trial record 14 of 621 for:    oximeter

Calibration and Validation of High Quality Low-Cost 3D Printed Pulse Oximeter

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ClinicalTrials.gov Identifier: NCT02846974
Recruitment Status : Unknown
Verified September 2017 by Tarek Loubani, MD, Lawson Health Research Institute.
Recruitment status was:  Not yet recruiting
First Posted : July 27, 2016
Last Update Posted : September 6, 2017
Sponsor:
Collaborators:
London Health Sciences Centre
Al Shifa Hospital, Gaza
University of Western Ontario, Canada
Information provided by (Responsible Party):
Tarek Loubani, MD, Lawson Health Research Institute

Brief Summary:
Pulse oximetry is a vital tool in the rapid and non-invasive assessment of emergency patients, providing a continuous estimate of hemoglobin saturation in arterial blood. Unfortunately, the costs of these devices are prohibitive and reduce availability in smaller centres and poor countries, putting millions of patients in danger of easily treatable and preventable conditions. With current rapid prototyping technologies such as 3D printing, it is possible to create a very inexpensive pulse oximeter that meets or exceeds the gold standard. The goal of this study is to develop, validate and certify a pulse oximeter that measures hemoglobin, carboxyhemoglobin and methemoglobin. This pulse oximeter will be certified with Health Canada, and then released under the Open Hardware License (OHL), such that hospitals and ministries of health in rural and impoverished communities in Canada and internationally would have easy access to these devices.

Condition or disease Intervention/treatment
Pulse Oximetry Free and Open Source Device: Pulse oximeter

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Calibration and Validation of High Quality Low-Cost 3D Printed Pulse Oximeter
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Group/Cohort Intervention/treatment
Calibration cohort
In this cohort, approximately 30 subjects will be put through a controlled desaturation study with controlled hypoxia until they arrive at approximately SpO2 = 70%. Measurements will be taken via arterial catheterization to resolve proper values to calibrate the device
Device: Pulse oximeter
A pulse oximeter will be used for calibration

Validation cohort
In this cohort, approximately 250 patients will have a single pulse oximetry reading taken using the novel device and a gold standard device to ensure accurate validation.
Device: Pulse oximeter
A pulse oximeter will be used for calibration




Primary Outcome Measures :
  1. Pulse oximetry reading [ Time Frame: 1 hour ]
    Pulse oximetry readings will be taken over the span of an hour to calibrate the device

  2. Arterial blood gas [ Time Frame: 1 hour ]
    Arterial blood gases will be taken to create a proper calibration curve along with the device's readings.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study has 2 Phases. In Phase 1, healthy, non-smoking adult volunteers greater than 18 years of age are invited to participate. In Phase 2, all adult (>18) non-critical patients and healthy community volunteers visiting the ED at VH and UH are eligible to participate.
Criteria

Inclusion Criteria:

- This study has 2 Phases. In Phase 1, healthy, non-smoking adult volunteers greater than 18 years of age are invited to participate. In Phase 2, all adult (>18) non-critical patients and healthy community volunteers visiting the ED at VH and UH are eligible to participate.

Exclusion Criteria:

Potential participants will be excluded based on the following criteria:

Phase 1:

  • greater than 70 years of age,
  • current smokers,
  • previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure),
  • history of moderate or severe asthma,
  • history of seizures,
  • history of stroke or transient ischemic attack
  • pregnant wome
  • Patients with any active pulmonary disease such as pneumonia
  • Individuals who are unwilling to participate or are less than 18 years old
  • Those who are unable to consent

Phase 2

  • Critical patients will be excluded from participating
  • Individuals who are unwilling to participate or are less than 18 years old will be excluded
  • Those who are unable to 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): NCT02846974


Contacts
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Contact: Tarek loubani, MD +15196858500 ext 54970 tarek@tarek.org

Locations
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Canada, Ontario
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 5W9
Contact: Tarek Loubani, MD    +15196858500 ext 54970    tarek@tarek.org   
Sponsors and Collaborators
Lawson Health Research Institute
London Health Sciences Centre
Al Shifa Hospital, Gaza
University of Western Ontario, Canada
Investigators
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Principal Investigator: Tarek Loubani, MD London Health Sciences Centre

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Responsible Party: Tarek Loubani, MD, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02846974     History of Changes
Other Study ID Numbers: 107952
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Keywords provided by Tarek Loubani, MD, Lawson Health Research Institute:
Pulse Oximetry
Free and Open Source