Sammenligning av pulsoksymetri (SpO2) med forskjellige oksymetre og arteriell metning (SaO2): Oxygap2-studie (Oxygap 2)
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
-
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Quebec
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Montreal, Quebec, Canada, H3T 1C5
- Rekruttering
- CHU Ste-Justine
-
Ta kontakt med:
- Michael Sauthier
- Telefonnummer: 514 345-4931
- E-post: Michael.Sauthier.med@ssss.gouv.qc.ca
-
Montreal, Quebec, Canada, H2X0A9
- Fullført
- CHUM
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Québec, Quebec, Canada, G1V 4G5
- Rekruttering
- Institut Universitaire de Cardiologie et de Pneumologie de Québec
-
Ta kontakt med:
- Francois Lellouche
- Telefonnummer: 3572 1-418-656-8711
- E-post: francois.lellouche@criucpq.ulaval.ca
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-
-
-
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Les Abymes, Guadeloupe, 97139
- Har ikke rekruttert ennå
- CHU de la Guadeloupe
-
Ta kontakt med:
- Frederic Martino
- Telefonnummer: : +590 590 89 11 32
- E-post: frederic.martino@chu-guadeloupe.fr
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-
-
-
-
Sousse, Tunisia, 4000
- Har ikke rekruttert ennå
- Hôpital Universitaire Farhat Hached,
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Ta kontakt med:
- Mohamed Boussarsar
- Telefonnummer: +216 73 102 500
- E-post: hamadi.boussarsar@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
All patient in ICU with arterial catheter already installed will be consider
Beskrivelse
Adult population
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Pediatric population
Pediatric population < 18 years old (estimated 100 patients) |
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 150 patients) |
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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference between GE oximeter SpO2 value and the SaO2 value on arterial blood gases
Tidsramme: During procedure (arterial blood gas sample collection)
|
Difference between GE oximeter SpO2 and the SaO2 value |
During procedure (arterial blood gas sample collection)
|
|
Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gases
Tidsramme: During procedure (arterial blood gassample collection)
|
Difference between Nellcor oximeter SpO2 and the SaO2 value |
During procedure (arterial blood gassample collection)
|
|
Difference between Masimo oximeter SpO2 value and the SaO2 value on arterial blood gases
Tidsramme: During procedure (arterial blood gas sample collection)
|
Difference between Masimo oximeter SpO2 and the SaO2 value |
During procedure (arterial blood gas sample collection)
|
|
Difference between Nonin oximeter SpO2 value and the SaO2 value on arterial blood gases
Tidsramme: During procedure (arterial blood gas sample collection)
|
Difference between Nonin oximeter SpO2 and the SaO2 value |
During procedure (arterial blood gas sample collection)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overestimation and underestimation of SaO2
Tidsramme: During procedure (arterial blood gas sample collection)
|
Percent of pairs with overestimation and underestimation of SaO2 for each oximeter. |
During procedure (arterial blood gas sample collection)
|
|
Hypoxemia detection
Tidsramme: During procedure (arterial blood gas sample collection)
|
Ability to detect hypoxemia (SpO2 below 90% and PaO2 < 60 mmHg) |
During procedure (arterial blood gas sample collection)
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hyperoxemia detection
Tidsramme: During procedure (arterial blood gas sample collection)
|
Ability to detect hyperoxemia (SpO2 above 95% and PaO2 > 100 mmHg) |
During procedure (arterial blood gas sample collection)
|
|
Gaps between the different oximeters
Tidsramme: During procedure (arterial blood gas sample collection)
|
Average of the SpO2 value gaps between the different oximeters tested |
During procedure (arterial blood gas sample collection)
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 22373
Plan for individuelle deltakerdata (IPD)
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