Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-20

Study Completion Date

2026-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 (General Electric-GE, Medtronic, Masimo and Nonin) 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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04772183

Respiratory Failure Hypoxemia Hyperoxemia

RECRUITING

Accuracy Validation of a Pulse Oximetry Monitor

NCT02506010

Healthy

WITHDRAWN

Hypoxia Blood Validation in Multiple Pulse Oximeters

NCT00881829

Hypoxia

UNKNOWN

Pulse Oximeter Accuracy in Healthy Humans During Hypoxia

NCT06142019

Hypoxia Skin Pigmentation

RECRUITING

Accuracy of Pulse Oximeters During Profound Hypoxia

NCT05790616

Hypoxia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Failure Hypoxemia Hyperoxemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pediatric population

Pediatric population \< 18 years old (estimated 100 patients)

SpO2 and SaO2 comparison

Intervention Type DEVICE

Several pulse oximeter will be place on patient find few minutes before arterial blood gases. During an arterial blood sample, all SpO2 will be recorded

Adult population

Adult population \>or= 18 years old (estimated 100 patients)

SpO2 and SaO2 comparison

Intervention Type DEVICE

Several pulse oximeter will be place on patient find few minutes before arterial blood gases. During an arterial blood sample, all SpO2 will be recorded

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SpO2 and SaO2 comparison

Several pulse oximeter will be place on patient find few minutes before arterial blood gases. During an arterial blood sample, all SpO2 will be recorded

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ≥ 18 years old (adult population) -
* Patients admitted to the Intensive Care Unit
* Artery catheter already installed

Pediatric population

* Below 18 years old
* Patients admitted to the Intensive Care Unit
* Artery catheter already installed

Exclusion Criteria

* No or poor signal with the usual pulse oximeter/based on clinician judgment
* High dose of vasopressors or inotropes (epinephrine or norepinephrine ˃ 1mcg/kg/min), shock state (lactates above 3 mmoles/L)
* Pigmented nails or nail polish
* Methemoglobinemia history
* Hemoglobin below 80 g/L
* Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-COV-2…)
* Prone position, Extra Corporel Membrane Oxygenator

Minimum Eligible Age

0 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No