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

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

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-24

Study Completion Date

2025-06-30

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 (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

Related Clinical Trials

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

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

NCT06102499

Respiratory Failure Hypoxemia Hyperoxemia

RECRUITING

Pulse Oximeter Hypoxia

NCT04562584

Oximetry

COMPLETED NA

Accuracy and Precision of Different Devices for the Monitoring of Pulsed Oxygen Saturation

NCT02832817

Arterial Pulsed Oxygen Saturation

UNKNOWN

Calibration and Evaluation of an Audio Pulse Oximeter Sensor (AudioOx) at Ascent and Descent From Simulated Altitude

NCT01732029

Blood Oxygen Saturation Level Heart Rate

COMPLETED NA

Pulse Oximeter Accuracy in Healthy Humans During Hypoxia

NCT06142019

Hypoxia Skin Pigmentation

RECRUITING

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

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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No