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- Essai clinique NCT06646991
Comparaison de plusieurs cibles d'oxygénation avec différentes interfaces d'oxygène - Impact sur les débits d'oxygène (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).
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: François Lellouche
- Numéro de téléphone: 1-418-656-8711
- E-mail: françoislellouche@criucpq.ulaval.ca
Lieux d'étude
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Quebec
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Québec, Quebec, Canada, G1V4G5
- Recrutement
- Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
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Contact:
- Francois Lellouche Principal Investigator
- Numéro de téléphone: 418-656-8711
- E-mail: francois.lellouche@criucpq.ulaval.ca
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Oxymètre Nellcor
|
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. |
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Autre: Oxymètre Nonin
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Oxygen flow
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Partial oxygen weaning
Délai: 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)
|
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Complete oxygen weaning
Délai: 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)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Gaps between the different oximeters
Délai: through period completion, minute 15
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Average of the SpO2 value gaps between the different oximeters tested |
through period completion, minute 15
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Gaps between PaCO2
Délai: through period completion, minute 15
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PaCO2 value at the end of the period |
through period completion, minute 15
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025-4198
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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