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Trial record 14 of 629 for:    oximeter

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

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: 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

Tracking Information
First Submitted Date July 23, 2016
First Posted Date July 27, 2016
Last Update Posted Date September 6, 2017
Estimated Study Start Date June 2018
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 23, 2016)
  • Pulse oximetry reading [ Time Frame: 1 hour ]
    Pulse oximetry readings will be taken over the span of an hour to calibrate the device
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02846974 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Calibration and Validation of High Quality Low-Cost 3D Printed Pulse Oximeter
Official Title Calibration and Validation of High Quality Low-Cost 3D Printed Pulse Oximeter
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Pulse Oximetry
  • Free and Open Source
Intervention Device: Pulse oximeter
A pulse oximeter will be used for calibration
Study Groups/Cohorts
  • 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
    Intervention: Device: Pulse oximeter
  • 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.
    Intervention: Device: Pulse oximeter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 23, 2016)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02846974
Other Study ID Numbers 107952
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Tarek Loubani, MD, Lawson Health Research Institute
Study Sponsor Lawson Health Research Institute
Collaborators
  • London Health Sciences Centre
  • Al Shifa Hospital, Gaza
  • University of Western Ontario, Canada
Investigators
Principal Investigator: Tarek Loubani, MD London Health Sciences Centre
PRS Account Lawson Health Research Institute
Verification Date September 2017