OxyGap : Comparison Between Different Pulse Oximeter and With the Arterial Blood Gase (OxyGap)

June 17, 2024 updated by: François Lellouche, Laval University

OxyGap : Comparison Between Different Pulse Oximeter and With the Arterial Blood

The oximeter is used to monitor intensive care patients undergoing oxygen therapy. It indicates pulsed oxygen saturation (SpO2), a reflection of arterial oxygen saturation (SaO2) which enables detection of hypoxemia and hyperoxia, both deleterious state. Current SpO2 recommendations aim to reduce both risk of hypoxemia and hyperoxia. SpO2 is considered the 5th vital sign.

Current recommendations for SpO2 targets do not consider the variability of oximeters used in clinical practice. This variability and lack of specification represent an obstacle to an optimal practice of oxygen therapy.

Thus, this study aims to compare the SpO2 values of different oximeters (Nonin, Masimo, Philips, Nellcor) used in clinical practice with the SaO2 reference value obtained by an arterial gas in order to specify the precision and the systematic biases of the oximeters studied. This data will also make it possible to refine the recommendations concerning optimal oxygenation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2X0A9
        • Not yet recruiting
        • CHUM
        • Contact:
          • Emmanuel Charbonney

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patient in ICU with arterial catheter already installed will be consider.

Description

Inclusion Criteria:

  • ≥ 18 years old
  • Patients admitted to the Intensive Care Unit
  • Artery catheter already installed

Exclusion Criteria:

  • No signal with the oximeter
  • Pigmented nails or nail polish
  • Methemoglobinemia
  • Patient in isolation (multi-resistant bacteria, C-Difficile, COVID-19…)
  • Prone position

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diffence between Nellcor SpO2 and the SaO2 value
Time Frame: During arterial blood gase sample
Diffence between Nellcor oximeter SpO2 and the SaO2 value
During arterial blood gase sample
Diffence between FreeO2 SpO2 and the SaO2 value
Time Frame: During arterial blood gase sample
Diffence between Nonin (FreeO2) oximeter SpO2 and the SaO2 value
During arterial blood gase sample
Diffence between Nonin ear clip and the SaO2 value
Time Frame: During arterial blood gase sample
Diffence between Nonin (ear sensor) oximeter SpO2 and the SaO2 value
During arterial blood gase sample
Diffence between Masimo SpO2 and the SaO2 value
Time Frame: During arterial blood gase sample
Diffence between Masimo oximeter SpO2 and the SaO2 value
During arterial blood gase sample
Diffence between Philips SpO2 and the SaO2 value
Time Frame: During arterial blood gase sample
Diffence between Philips oximeter SpO2 and the SaO2 value
During arterial blood gase sample
Diffence between Contec SpO2 and the SaO2 value
Time Frame: During arterial blood gase sample
Difffence between Contec oximeter SpO2 and the SaO2 value
During arterial blood gase sample
Diffence between Bejing choice SpO2 and the SaO2 value
Time Frame: During arterial blood gase sample
Diffence between Bejing choice oximeter SpO2 and the SaO2 value
During arterial blood gase sample

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overestimation and underestimation of SaO2
Time Frame: During arterial blood gase sample
% of pairs with overestimation and underestimation of SaO2 for each oximeter.
During arterial blood gase sample
Hypoxemia detection
Time Frame: During arterial blood gase sample
Ability to detect hypoxemia (SpO2 below 90% and PaO2 < 60 mmHg)
During arterial blood gase sample
Hyperoxemia detection
Time Frame: During arterial blood gase sample
Ability to detect hyperoxemia (SpO2 above 95% and PaO2 > 100 mmHg)
During arterial blood gase sample
Gaps between the different oximeters
Time Frame: During arterial blood gase sample
Average of the SpO2 value gaps between the different oximeters tested
During arterial blood gase sample
Finger and ear sensor comparison
Time Frame: During arterial blood gase sample
Comparison of the finger sensor and ear clip sensor for Nonin oximeter
During arterial blood gase sample

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-3624

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

Dietary Supplements

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Locations

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