Jämförelse av pulsoximetri (SpO2) med olika oximetrar och artärmättnad (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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
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Les Abymes, Guadeloupe, 97139
- Har inte rekryterat ännu
- CHU de la Guadeloupe
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Kontakt:
- Frederic Martino
- Telefonnummer: : +590 590 89 11 32
- E-post: frederic.martino@chu-guadeloupe.fr
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Quebec
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Montreal, Quebec, Kanada, H3T 1C5
- Rekrytering
- CHU Ste-Justine
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Kontakt:
- Michael Sauthier
- Telefonnummer: 514 345-4931
- E-post: Michael.Sauthier.med@ssss.gouv.qc.ca
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Montreal, Quebec, Kanada, H2X0A9
- Avslutad
- CHUM
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Québec, Quebec, Kanada, G1V 4G5
- Rekrytering
- Institut Universitaire de Cardiologie et de Pneumologie de Québec
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Kontakt:
- Francois Lellouche
- Telefonnummer: 3572 1-418-656-8711
- E-post: francois.lellouche@criucpq.ulaval.ca
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Sousse, Tunisien, 4000
- Har inte rekryterat ännu
- Hôpital Universitaire Farhat Hached,
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Kontakt:
- Mohamed Boussarsar
- Telefonnummer: +216 73 102 500
- E-post: hamadi.boussarsar@gmail.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
All patient in ICU with arterial catheter already installed will be consider
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Difference between GE oximeter SpO2 value and the SaO2 value on arterial blood gases
Tidsram: During procedure (arterial blood gas sample collection)
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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
Tidsram: 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
Tidsram: 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
Tidsram: During procedure (arterial blood gas sample collection)
|
Difference between Nonin oximeter SpO2 and the SaO2 value |
During procedure (arterial blood gas sample collection)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overestimation and underestimation of SaO2
Tidsram: 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
Tidsram: 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)
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Hyperoxemia detection
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 22373
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