- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06646991
Sammenligning av flere oksygeneringsmål med forskjellige oksygengrensesnitt - innvirkning på oksygenstrømningshastigheter (Interfaces)
Oxygen therapy is at the heart of the healthcare system. Oxygen flow rates depend on a number of confounding factors confounding factors (target used, skin pigmentation, pulse oximeter used, etc.) The investigators have recently have recently demonstrated that the combination of these factors (different peripheral oxygen saturation (SpO2) targets and different oximeters) can have a significant impact on oxygen flows rates. The effect on oxygen flow was not simply additive .
The aim of this study is to evaluate the impact of the interface used on oxygen flow rates in different patient populations (main objective). The investigatoers also evaluate the impact of the interface on carbon dioxide (PaCO2), in particular with closed oxygen masks, with which rebreathing is theoretically possible (secondary objective).
secondary objective).
Studieoversikt
Status
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: François Lellouche
- Telefonnummer: 1-418-656-8711
- E-post: françoislellouche@criucpq.ulaval.ca
Studiesteder
-
-
Quebec
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Québec, Quebec, Canada, G1V4G5
- Rekruttering
- Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
-
Ta kontakt med:
- Francois Lellouche Principal Investigator
- Telefonnummer: 418-656-8711
- E-post: francois.lellouche@criucpq.ulaval.ca
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Adult (> or = 18 years old)
- Ongoing on conventional oxygen therapy with peripheral oxygen saturation (SpO2) between 88 and 100% with the usual oximeter
- SpO2 < 92% ambient air with the usual oximeter
Exclusion Criteria:
- No SpO2 signal with with the usual oximeter
- False nails or nail polish
- Severe anemia documented on last blood count during current hospitalization (haemoglobin (Hb) < 80g/L)
- Oxygen flow > 6 L/min
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Nellcor oksymeter
|
Oxygen will be administered via nasal cannula up to 6 liters per minute during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the peripheral oxygen saturation (SpO2) target (92% for non chronic obstructive pulmonary disease (non COPD) patient and 90% for chronic obstructive pulmonary disease (COPD) patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used. Oxygen will be administered via nasal cannula up to 15 liters per minute during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used. Oxygen will be administered via an open during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used. Oxygen will be administered via simple oxygen face mask during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used. |
|
Annen: Nonin oksymeter
|
Oxygen will be administered via nasal cannula up to 6 liters per minute during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the peripheral oxygen saturation (SpO2) target (92% for non chronic obstructive pulmonary disease (non COPD) patient and 90% for chronic obstructive pulmonary disease (COPD) patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Oxygen flow
Tidsramme: Mean Oxygen flow in the five last minute of each study period (between minute 10 and 15)
|
Oxygen flows (or fraction of inspired oxygen (FiO2)) at the end of each study period (last minute average) to reach peripheral oxygen saturation (SpO2) target to reach SpO2 target with specific oxygen administration interfaces |
Mean Oxygen flow in the five last minute of each study period (between minute 10 and 15)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Partial oxygen weaning
Tidsramme: Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)
|
Rate of partial oxygen weaning (Oxygen flow <=0.5 L/min) |
Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)
|
|
Complete oxygen weaning
Tidsramme: Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)
|
Rate of complete oxygen weaning (Oxygen flow =0 L/min or FiO2 0.21) |
Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Gaps between the different oximeters
Tidsramme: through period completion, minute 15
|
Average of the SpO2 value gaps between the different oximeters tested |
through period completion, minute 15
|
|
Gaps between PaCO2
Tidsramme: through period completion, minute 15
|
PaCO2 value at the end of the period |
through period completion, minute 15
|
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
- 2025-4198
Plan for individuelle deltakerdata (IPD)
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