Jämförelse av två syresättningsmål med två olika oximetrar - Inverkan på syreflödeshastigheter och syresättning (Oxygap pong)
The investigators recently evaluated 4 different oximeters among the most commonly used with arterial catheter in place and compared SpO2 with SaO2 obtained on arterial gas. Correlations between SaO2 and SpO2 were poor for all oximeters, as previously known, and SpO2-SaO2 bias were different between oximeters. Some oximeters (Masimo, Nellcor) had lower biases but they detected less well hypoxemia. Some oximeters underestimated SaO2 (Nonin) but detected very well hypoxemia, and some overestimated SaO2 (Philips). The investigators concluded that oximeters provide different informations to clinicians, and oxygenation targets should take into account for these differences.
The assumption is that the SpO2 target AND oximeter used will both have an impact on oxygen flows and that these effects will add up. With a high SpO2 target, oxygen flows will be significantly greater and with the Nonin oximeter, the required flows will be greater than with the Philips oximeter.
NB: the results obtained were in a population with light skin pigmentation (96% of the patients were Fitzpatrick 1-2, reflecting the local hospitalized population).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The oximeters to be evaluated will be the Nonin (Plymouth, MN), and the Philips (Eindhoven, Netherlands). The sensors used will be digital reusable sensors for all oximeters. Because of the impact of the fingers used for SpO2 measurement, each oximeter will be randomly assigned a different finger to each patient (digit 2 and 3 on the hand opposite to the arterial catheter).
Two SpO2 targets will be assessed: 90% and 94%. A total of four 10-minute periods will be performed in randomized order: Nonin 90, Nonin 94, Philips 90, and Philips 94.
At the end of each 10-minute period, arterial gas will be collected through the arterial catheter.
The adjustment of the oxygen flow rates will be performed manually. The average oxygen flow of the last 2 minutes of the period will be considered.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Francois Lellouche
- Telefonnummer: 3572 418656-8711
- E-post: francois.lellouche@criucpq.ulaval.ca
Studera Kontakt Backup
- Namn: Pierre Alexandre Bouchard
- Telefonnummer: 2712 418656-8711
- E-post: pierre-alexandre.bouchard@criucpq.ulaval.ca
Studieorter
-
-
Quebec
-
Québec, Quebec, Kanada, G1V4G5
- Rekrytering
- Institut Universitaire de Cardiologie et de Pneumologie de Québec
-
Kontakt:
- Francois Lellouche
- E-post: francois.lellouche@criucpq.ulaval.ca
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- ≥ 18 years of age
- Patients admitted to postoperative cardiac surgery intensive care unit
- Presence of an arterial catheter Specific for the extubate patient
- Ongoing on conventional oxygen therapy at moderate flow (up to a maximum of 5L/min) with SpO2 between 88 and 100% with the usual oximeter and nasal cannula.
- SpO2 < 92% ambient air Specific for the intubate patient FiO2 <= 0.60 with SpO2 between 88 and 100% with usual oximeter SpO2 < 92% with FiO2 0.21
Exclusion Criteria:
- No SpO2 signal with oximeter in use
- False nails or nail polish
- Methemoglobinemia >0.015 on last available arterial gas
- Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-CoV-2 ...) Specific for the extubate patient
- Expected to use another respiratory support within one hour of inclusion (NIV or nasal high flow oxygen) Planned extubation within one hour of inclusion
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Nonin oximeter with a 90% SpO2 target
During this periods , oxygen will be administered in an manual titration with the FreeO2 device (fixed flow mode) to reach 90% of SpO2. |
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Nonin oximeter |
|
Experimentell: Philips oximeter with a 90% SpO2 target
During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 90% of SpO2. |
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Philips oximeter |
|
Experimentell: Nonin oximeter with a 94% SpO2 target
During this periods , oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode) to reach 94% of SpO2. |
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter |
|
Experimentell: Philips oximeter with a 94% SpO2 target
During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 94% of SpO2. |
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Oxygen flow (or FiO2)
Tidsram: Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
Oxygen flows (or FiO2) at the end of each study period (last minute average) to reach SpO2 target to reach SpO2 target with specific oximeter |
Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Difference between SpO2 and SaO2
Tidsram: assessed up to 10 minutes - at the same of the arterial blood gases punction
|
Difference (%) between SpO2 from each oximeter and SaO2 (% of SaO2 overestimation and underestimation for each oximeter) |
assessed up to 10 minutes - at the same of the arterial blood gases punction
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean difference on oxymeter
Tidsram: assessed up to 10 minutes - at the same of the arterial blood gases punction
|
Mean (±SD) of the gaps between the different oximeters tested |
assessed up to 10 minutes - at the same of the arterial blood gases punction
|
|
Occult hypoxemia
Tidsram: assessed up to 10 minutes - at the same of the arterial blood gases punction
|
Percentage of occult hypoxemia (SaO2<90% and SpO2>=90%) |
assessed up to 10 minutes - at the same of the arterial blood gases punction
|
|
Occult hyperoxemia
Tidsram: assessed up to 10 minutes - at the same of the arterial blood gases punction
|
Perrcentage of occult hyperoxemia (SaO2>96% and SpO2<=96%) |
assessed up to 10 minutes - at the same of the arterial blood gases punction
|
|
Partial oxygen weaning
Tidsram: Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
Rate of partial oxygen weaning (Oxygen flow <=0.5 L/min) |
Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
|
Complete oxygen weaning
Tidsram: Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
Rate of complete oxygen weaning (Oxygen flow =0 L/min or FiO2 0.21) |
Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
|
Respiratory support escalation
Tidsram: Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
Indication of initiation of respiratory support escalation (Oxygen flow >6 L/min or FiO2 > 0.60) |
Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
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
- 22266
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .