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

NCT04772183 | Recruiting

• 1 other identifier: 2021-3624
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Respiratory Failure; Hypoxemia; Hyperoxemia

Outcome Measures

Primary Outcomes (7)

• Diffence between Nellcor SpO2 and the SaO2 value

  Diffence between Nellcor oximeter SpO2 and the SaO2 value

  During arterial blood gase sample

• Diffence between FreeO2 SpO2 and the SaO2 value

  Diffence between Nonin (FreeO2) oximeter SpO2 and the SaO2 value

  During arterial blood gase sample

• Diffence between Nonin ear clip and the SaO2 value

  Diffence between Nonin (ear sensor) oximeter SpO2 and the SaO2 value

  During arterial blood gase sample

• Diffence between Masimo SpO2 and the SaO2 value

  Diffence between Masimo oximeter SpO2 and the SaO2 value

  During arterial blood gase sample

• Diffence between Philips SpO2 and the SaO2 value

  Diffence between Philips oximeter SpO2 and the SaO2 value

  During arterial blood gase sample

• Diffence between Contec SpO2 and the SaO2 value

  Difffence between Contec oximeter SpO2 and the SaO2 value

  During arterial blood gase sample

• Diffence between Bejing choice SpO2 and the SaO2 value

  Diffence between Bejing choice oximeter SpO2 and the SaO2 value

  During arterial blood gase sample

Secondary Outcomes (5)

• Overestimation and underestimation of SaO2

  During arterial blood gase sample

• Hypoxemia detection

  During arterial blood gase sample

• Hyperoxemia detection

  During arterial blood gase sample

• Gaps between the different oximeters

  During arterial blood gase sample

• Finger and ear sensor comparison

  During arterial blood gase sample

Interventions

SpO2 and SaO2 comparison 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Laval University: lead

Study Sites (2)

CHUM

Montreal, Quebec, H2X0A9, Canada

NOT YET RECRUITING

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, G1V4G5, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Hypoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

François Lellouche

CONTACT

418-656-8711; francois.lellouche@criucpq.ulaval.ca

Pierre-alexandre Bouchard

CONTACT

418-656-8711; pierre-alexandre.bouchard@criucpq.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 26, 2021
• Study Start: March 24, 2021
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)