Respiratory FailureOxyGapNCT04772183
OxyGap : Comparison Between Different Pulse Oximeter and With the Arterial Blood Gase
An observational study of Respiratory Failure and Hypoxemia, run by Laval University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Hypoxemia, Hyperoxemia
- What is being tested?
- SpO2 and SaO2 comparison
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 2 sitesCanada
- Study dates
- 24 Mar 2021to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All patient in ICU with arterial catheter already installed will be consider.
Who may be able to join
- ≥ 18 years old
- Patients admitted to the Intensive Care Unit
- Artery catheter already installed
Who cannot join
- No signal with the oximeter
- Pigmented nails or nail polish
- Methemoglobinemia
- Patient in isolation (multi-resistant bacteria, C-Difficile, COVID-19…)
- Prone position
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Not yet recruiting
CHUM
Montreal, Quebec, H2X0A9
Emmanuel Charbonney
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, G1V4G5
Francois Lellouche, francois.lellouche@criucpq.ulaval.ca
About this study
Official title: 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
- Conditions
- Respiratory Failure, Hypoxemia, Hyperoxemia
- Being tested
- SpO2 and SaO2 comparison
- Medical subject headings
- Respiratory Insufficiency, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpO2 and SaO2 comparisonDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffence between Nellcor SpO2 and the SaO2 value
Diffence between Nellcor oximeter SpO2 and the SaO2 value
Measured: During arterial blood gase sample
Diffence between FreeO2 SpO2 and the SaO2 value
Diffence between Nonin (FreeO2) oximeter SpO2 and the SaO2 value
Measured: 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
Measured: During arterial blood gase sample
Diffence between Masimo SpO2 and the SaO2 value
Diffence between Masimo oximeter SpO2 and the SaO2 value
Measured: During arterial blood gase sample
Diffence between Philips SpO2 and the SaO2 value
Diffence between Philips oximeter SpO2 and the SaO2 value
Measured: During arterial blood gase sample
Diffence between Contec SpO2 and the SaO2 value
Difffence between Contec oximeter SpO2 and the SaO2 value
Measured: During arterial blood gase sample
Diffence between Bejing choice SpO2 and the SaO2 value
Diffence between Bejing choice oximeter SpO2 and the SaO2 value
Measured: During arterial blood gase sample
Secondary outcomes (5)
Overestimation and underestimation of SaO2
% of pairs with overestimation and underestimation of SaO2 for each oximeter.
Measured: During arterial blood gase sample
Hypoxemia detection
Ability to detect hypoxemia (SpO2 below 90% and PaO2 < 60 mmHg)
Measured: During arterial blood gase sample
Hyperoxemia detection
Ability to detect hyperoxemia (SpO2 above 95% and PaO2 > 100 mmHg)
Measured: During arterial blood gase sample
Gaps between the different oximeters
Average of the SpO2 value gaps between the different oximeters tested
Measured: During arterial blood gase sample
Finger and ear sensor comparison
Comparison of the finger sensor and ear clip sensor for Nonin oximeter
Measured: During arterial blood gase sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start24 Mar 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François Lellouche, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772183
- Sponsor's protocol ID
- 2021-3624
- Acronym
- OxyGap
- Status last verified
- Jun 2024
- First submitted
- 17 Feb 2021
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OxyGap : Comparison Between Different Pulse Oximeter and With the Arterial Blood
- ClinicalTrials.gov ID
- NCT04772183
- Acronym / sponsor ID
- OxyGap / 2021-3624
- Conditions
- Respiratory Failure, Hypoxemia, Hyperoxemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patient in ICU with arterial catheter already installed will be consider.
Key inclusion criteria (3 listed)
- ≥ 18 years old
- Patients admitted to the Intensive Care Unit
- Artery catheter already installed
Key exclusion criteria (5 listed)
- No signal with the oximeter
- Pigmented nails or nail polish
- Methemoglobinemia
- Patient in isolation (multi-resistant bacteria, C-Difficile, COVID-19…)
- Prone position
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpO2 and SaO2 comparisonSeveral pulse oximeter will be place on patient find few minutes before arterial blood gases. During an arterial blood sample, all SpO2 will be recorded | Device | – |
Primary outcome
Diffence between Nellcor SpO2 and the SaO2 value
Time frame: During arterial blood gase sample
Diffence between Nellcor oximeter SpO2 and the SaO2 value
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
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
Diffence between Masimo SpO2 and the SaO2 value
Time frame: During arterial blood gase sample
Diffence between Masimo oximeter SpO2 and the SaO2 value
Diffence between Philips SpO2 and the SaO2 value
Time frame: During arterial blood gase sample
Diffence between Philips oximeter SpO2 and the SaO2 value
Diffence between Contec SpO2 and the SaO2 value
Time frame: During arterial blood gase sample
Difffence between Contec oximeter SpO2 and the SaO2 value
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
5 secondary outcomes
Overestimation and underestimation of SaO2
Time frame: During arterial blood gase sample
Hypoxemia detection
Time frame: During arterial blood gase sample
Hyperoxemia detection
Time frame: During arterial blood gase sample
Gaps between the different oximeters
Time frame: During arterial blood gase sample
Finger and ear sensor comparison
Time frame: During arterial blood gase sample
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Hypoxemia, run by Laval University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François Lellouche (418-656-8711 ext. 3572, francois.lellouche@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffence between Nellcor SpO2 and the SaO2 value (time frame: During arterial blood gase sample). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.