Calibration and Validation of High Quality Low-Cost 3D Pr... | NCT02846974

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

NCT02846974

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Unknown status

Last Update Posted

Aug 25, 2022Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Pulse Oximetry
Free and Open Source

Interventions

Pulse oximeter

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2019Actual

Primary Completion Date

Jul 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jul 23, 2016

First Submission Date that Met QC Criteria

Jul 23, 2016

First Posted Date

Jul 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2022

Last Update Posted Date

Aug 25, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tarek Loubani, MD, Principal Investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPrincipal Investigator

Lead Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sOTHER

Collaborators

Name	Class
London Health Sciences Centre	OTHER
Al Shifa Hospital, Gaza	UNKNOWN
University of Western Ontario, Canada	OTHER

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulse oximeter	Device	A pulse oximeter will be used for calibration	Calibration cohort Validation cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pulse oximetry reading	Pulse oximetry readings will be taken over the span of an hour to calibrate the device	1 hour
Arterial blood gas	Arterial blood gases will be taken to create a proper calibration curve along with the device's readings.	1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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 women
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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

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 emergency department at Victoria Hospital and University Hospital are eligible to participate.

Sampling Method

Non-Probability Sample