Clinical Trials Logo

Clinical Trial Summary

The main objective of our study is to determine whether asymptomatic influenza virus carriage is associated with an increased risk of post-operative Acute Respiratory Distress Syndrome (ARDS) after cardiac surgery. Cardiac surgery patients are particularly at risk of developing ARDS with an estimated incidence of 5-10% based on the most recent data.


Clinical Trial Description

The primary objective of our study is to determine whether asymptomatic influenza virus carriage is associated with an increased risk of post-operative Acute Respiratory Distress Syndrome (ARDS) after cardiac surgery. Cardiac surgery patients are particularly at risk of developing ARDS, with an estimated incidence of 5-10% based on the most recent data. Acute Respiratory Distress Syndrome (ARDS) is an acute pulmonary attack of inflammatory origin. ARDS is the main cause of hypoxemic postoperative respiratory distress. Hospital mortality associated with ARDS is estimated at 35-46% depending on the degree of severity, and survivors are at increased risk of cognitive decline, depression, post-traumatic stress, or musculoskeletal weakness. Recently, asymptomatic carriage of respiratory viruses, including the influenza virus, has been identified as a potential risk factor for respiratory complications, including ARDS, after cardiac surgery. In a monocentric observational cohort, Groeneveld et al. recently reported that performing scheduled cardiac surgery during the influenza season was associated with a significantly longer duration of postoperative mechanical ventilation and a higher incidence of postoperative ARDS compared to surgery performed outside the influenza season (OR 1.85 95%CI 1.06-3.23 p=0.03). While it is estimated that up to 77% of patients with positive influenza tests are asymptomatic in the general population, the authors hypothesized that asymptomatic viral lung carriage would act as pulmonary priming, which, in combination with other types of pulmonary attacks encountered during surgery, would predispose to the genesis of ARDS. However, Groeneveld et al. had not tested any respiratory viruses in their cohort. In addition, the relatively higher influenza vaccination rate in the Netherlands in this at-risk population (77%) suggests that other types of respiratory viruses may have contributed to the observed effect. These data are of major interest. Indeed, in France, during the 2017-2018 epidemic season, the vaccination rate of individuals at risk was only 46%, with an estimated vaccine efficacy of only 54% in elderly patients. The aim of this study is to determine if there is an association between asymptomatic carriage of respiratory virus, especially influenza virus, and the occurrence of post-operative complications, morbidity and mortality. If an association between asymptomatic carriage of influenza virus, or other respiratory viruses, and the occurrence of post-operative respiratory complications, including ARDS, is confirmed, a policy of routine immunization prior to cardiac surgery or postponement of scheduled surgery in the event of a positive viral test could be a simple and inexpensive strategy to reduce these complications after cardiac surgery. Pre-emptive antiviral therapy could be discussed when neither of these strategies is possible (e.g., emergency surgery). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04562207
Study type Interventional
Source Rennes University Hospital
Contact
Status Completed
Phase N/A
Start date February 9, 2021
Completion date March 10, 2023

See also
  Status Clinical Trial Phase
Withdrawn NCT03282292 - Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery N/A
Completed NCT05264766 - The Use of Cooling Helmet for Neuroprotection Management in Open Heart Surgery N/A
Completed NCT05032469 - Foot Reflexology to Reduce Pain and Anxiety Before Chest Tube Removal N/A
Completed NCT03309137 - Device for Bacteremia Prevention in Post Cardiac Surgical Intensive Care Unit Patients N/A
Recruiting NCT05740397 - Trial to Compare Different Strategies of Mean Arterial Pressure Management During Cardiopulmonary By-pass N/A
Completed NCT05824598 - Multifunctional Approach in Cardiac Surgery N/A
Recruiting NCT05178680 - Combination of Music and Relaxing Light on the Patient's Anxiety After Cardiac Surgery in the Intensive Care Unit N/A
Recruiting NCT03491163 - Evaluation of Damaging Factors to Endothelial Glycocalyx During Heart Surgery Pilot Study
Completed NCT05763238 - Exercise Training in Children With Corrective Cardiac Surgeries N/A
Completed NCT01926067 - Monitoring of Cardiac Function With 3-axis Accelerometers N/A
Recruiting NCT04094168 - Clinical Impact of Del Nido Cardioplegia in Adult Cardiac Surgery Phase 4
Completed NCT04197570 - Opioid-free Anesthesia for Open Cardiac Surgery: A Prospective Randomized Controlled Trial Phase 3
Completed NCT05966857 - FAPO-X: Assisted Digital Telemonitoring With Wearables in Patients After Cardiovascular Surgery N/A
Completed NCT05656937 - Oblique Versus Transverse Orientation Approach for Internal Jugular Venous Cannulation in Pediatrics N/A
Completed NCT01141556 - Effects of High-dose Intravenous Selenium (Selenase®) in Adult Patients Subjected to Elective All-cause Heart Surgery Phase 3
Completed NCT05902052 - Development of Open Heart Surgery Patient Care Protocol and Its Effect on Post-sternotomy Pain N/A
Completed NCT06085066 - The Role of Modified Ultrafiltration Following Open Heart Surgery N/A
Completed NCT06435715 - The Effect of 10 Repetitions of Deep Breathing Exercises N/A
Not yet recruiting NCT06286111 - Red Cell Distribution Width as a Predictor for Post Operative Atrial Fibrillation After Open Heart Surgries
Completed NCT03429335 - Just TRAC It! Transitioning Responsibly to Adult Care Using Smart Phone Technology N/A