Incidence of Postoperative Persistent Diaphragmatic Dysfunctions in Cardiac Surgery
NCT ID: NCT04276844
Last Updated: 2021-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
157 participants
OBSERVATIONAL
2020-03-04
2021-01-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparative Ultrasonic Study of Post Operative Diaphragmatic Dysfunction in Abdominal and Head and Neck Surgery
NCT01737775
Contract-Relax (CR) Technique in the Management of Diaphragmatic Paresis After Cardiac Surgery
NCT05068219
Hyperoxia and Pulmonary Complications After Cardiac Surgery
NCT04278066
Early Identification of Patients in Surgical Intensive Care With a Risk of Acute Respiratory Distress Following Visceral Surgery
NCT03289975
Diaphragmatic Inspiratory Amplitude as a Prognosticator for Postoperative Pulmonary Complications After Cardiac Surgery
NCT06396767
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients with persistent DD at day 7 post-surgery will have additional Respiratory Functional Explorations.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Non diaphragmatic dysfunction at day 7 post-surgery
Diaphragmatic displacement after sniff test ≥ 16 mm for women and ≥ 18 mm for men
Ultrasonography using the two-dimensional (2D) mode
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
Ultrasonography using the two-dimensional (2D) mode
Diaphragmatic amplitude assessed by ultrasonography during quiet breathing and after sniff test, before the surgery and at day 7 post-surgery in all patients.
Respiratory Functional Explorations
Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV) and total lung capacity (TLC) measured at day 7
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ultrasonography using the two-dimensional (2D) mode
Diaphragmatic amplitude assessed by ultrasonography during quiet breathing and after sniff test, before the surgery and at day 7 post-surgery in all patients.
Respiratory Functional Explorations
Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV) and total lung capacity (TLC) measured at day 7
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Consent for participation
* Affiliation to the social security system
Exclusion Criteria
* Pregnant or breastfeeding women
* Patients under protection of the adults (guardianship, curators or safeguard of justice)
* Communication difficulties or neuropsychiatric disorder
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CMC Ambroise Paré
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CMC Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Laghlam D, Naudin C, Srour A, Monsonego R, Malvy J, Rahoual G, Squara P, Nguyen LS, Estagnasie P. Persistent diaphragm dysfunction after cardiac surgery is associated with adverse respiratory outcomes: a prospective observational ultrasound study. Can J Anaesth. 2023 Feb;70(2):228-236. doi: 10.1007/s12630-022-02360-8. Epub 2022 Dec 13.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019/06
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.