CMC Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, 92200, France
NCT Number: NCT04276844
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.
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Notify Me18 year and older
All sexes
Observational
Neuilly-sur-Seine, Île-de-France Region, 92200, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 8 days
Diaphragmatic excursion measured during sniff test (displacement, mm)
Time frame: up to 2 months
Occurrence of pneumonia, atelectasis requiring bronchial clearing by fibroscopy, reintubation, prolonged mechanical ventilation (>24h) or prolonged non-invasive ventilation (>48h)
Time frame: up to 2 months
Duration of ICU stay measured in days
Time frame: up to 2 months
Duration of hospitalization measured in days
Time frame: 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
CMC Ambroise Paré
Other
Acronym: INDYD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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