- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04276844
Incidence of Postoperative Persistent Diaphragmatic Dysfunctions in Cardiac Surgery (INDYD)
Postoperative respiratory complication is a common complication that occurs in 6% of patients after cardiac surgery and increases morbidity and mortality and hospital length of stay. Diaphragmatic dysfunction (DD) is one of the main risk factors for post-operative respiratory distress syndrome. It alters the ventilatory mechanical function of patients and promotes pneumonia. In the literature, risk factors included older age, diabetes, harvesting of a mammary artery, intraoperative ice solution using, prolonged cardiopulmonary bypass and intra-operative phrenic nerve injury.
Ultrasonography using the two-dimensional (2D) mode is a diagnosis tool for DD. For patients with DD, ultrasound criteria are: 1) an excursion during quiet breathing < 9 mm for woman and < 10 mm for man, 2) an excursion after sniff test < 16 mm for woman and < 18 mm for man and 3) an excursion during deep breathing < 37 mm for woman and < 47 mm for man. A paradoxical diaphragmatic ascent may also be observed during inspiration.
DD may be transient, linked to mechanical factors such as pain, the presence of pleural and mediastinal drains, lying down or sternotomy; with recovery from 5 postoperative days. It may be more prolonged (persistent after 7 days) in connection with a partial or complete phrenic nerve injury and / or diaphragmatic devascularization after mammary artery harvesting.
The aim of this prospective study is to determine the incidence of persistent DD after cardiac surgery.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Diaphragmatic amplitude will be assessed by ultrasonography during quiet breathing and after sniff test, before the surgery and at day 7 post-surgery in all patients.
Patients with persistent DD at day 7 post-surgery will have additional Respiratory Functional Explorations.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Ile-de-France
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Neuilly-sur-Seine, Ile-de-France, France, 92200
- CMC Ambroise Paré
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients undergoing cardiac surgery requiring sternotomy
- Consent for participation
- Affiliation to the social security system
Exclusion Criteria:
- Contraindication to preoperative respiratory functional explorations
- Pregnant or breastfeeding women
- Patients under protection of the adults (guardianship, curators or safeguard of justice)
- Communication difficulties or neuropsychiatric disorder
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Non diaphragmatic dysfunction at day 7 post-surgery
Diaphragmatic displacement after sniff test ≥ 16 mm for women and ≥ 18 mm for men
|
Diaphragmatic amplitude assessed by ultrasonography during quiet breathing and after sniff test, before the surgery and at day 7 post-surgery in all patients.
|
Persistent diaphragmatic dysfunction at day 7 post-surgery
Diaphragmatic displacement after sniff test < 16 mm for women and < 18 mm for men
|
Diaphragmatic amplitude assessed by ultrasonography during quiet breathing and after sniff test, before the surgery and at day 7 post-surgery in all patients.
Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV) and total lung capacity (TLC) measured at day 7
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Incidence of persistent diaphragmatic dysfunctions after cardiac surgery
Délai: 8 days
|
Diaphragmatic excursion measured during sniff test (displacement, mm)
|
8 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Incidence of respiratory complications
Délai: up to 2 months
|
Occurrence of pneumonia, atelectasis requiring bronchial clearing by fibroscopy, reintubation, prolonged mechanical ventilation (>24h) or prolonged non-invasive ventilation (>48h)
|
up to 2 months
|
Intensive Care Unit (ICU) length of stay
Délai: up to 2 months
|
Duration of ICU stay measured in days
|
up to 2 months
|
Hospital length of stay
Délai: up to 2 months
|
Duration of hospitalization measured in days
|
up to 2 months
|
Respiratory function test in the group with persistent diaphragmatic dysfunction
Délai: 8 days
|
Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV) and total lung capacity (TLC) measured at day 7 and compared to day 0
|
8 days
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Autres numéros d'identification d'étude
- 2019/06
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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