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Reduction of drainage-associated complications in cardiac surgery with a digital drainage system: a randomized controlled trial.

ABSTRACT: Background:Thoracic chest drains are placed after cardiac surgery allowing for the clearance of blood, fluid, and air to prevent post-operative complications. Despite its importance, there is little data on the application of digital chest drainage systems in cardiac surgery. Therefore, the differences between an analog and a digital chest drainage system in cardiac surgery patients were investigated in a randomized controlled trial. Methods:A total of 354 elective cardiac surgery patients were preoperatively randomized 1:1 between September 2016 and September 2017 to either an analog (Ocean) or a digital (Thopaz+) chest drainage system aiming to compare drainage-associated postoperative outcome parameters. Results:A total of 340 patients were included in the analysis (analog: 188; digital: 152) with no significant differences in preoperative baseline parameters. Incidence of X-rays to detect air leaks was significantly lower in the digital group (analog: 20.2%; digital: 8.6%; P<0.01). Patients treated with the digital system showed a 3.3% reduction of re-thoracotomies, however, not statistically significant (analog: 5.3%; digital: 2.0%; P=0.19). Median total fluid amount did not significantly differ between study groups [median (P25; P75); analog: 705 (400; 1,333) mL; digital: 686 (404; 1,229) mL; P=0.83]; however, the use of the digital drainage system resulted in a quicker removal with a reduced median drainage duration of 16 hours (analog: 65 hours; digital: 49 hours; P?0.01). Conclusions:The study provides evidence that digital drainage systems can be safely applied in cardiac surgery patients. The use of the digital management system led to a decreased incidence of drainage-associated complications as well as to shortened chest tube duration. Findings require confirmation by additional studies.

SUBMITTER: Van Linden A

PROVIDER: S-EPMC6988078 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Reduction of drainage-associated complications in cardiac surgery with a digital drainage system: a randomized controlled trial.

Van Linden Arnaud A Hecker Florian F Courvoisier Delphine S DS Arsalan Mani M Köhne Josepha J Brei Christina C Holubec Tomas T Walther Thomas T

Journal of thoracic disease 20191201 12

<h4>Background</h4>Thoracic chest drains are placed after cardiac surgery allowing for the clearance of blood, fluid, and air to prevent post-operative complications. Despite its importance, there is little data on the application of digital chest drainage systems in cardiac surgery. Therefore, the differences between an analog and a digital chest drainage system in cardiac surgery patients were investigated in a randomized controlled trial.<h4>Methods</h4>A total of 354 elective cardiac surgery ...[more]

PMID: 32030235

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Project description:Background:Despite decades of investigation, the balance of clinical risks and benefits of fluid supplementation with starch remain unresolved. Patient-centered outcomes have not been well explored in a "real-world" trial in cardiac surgery. Objective:We sought to compare a starch-based fluid strategy with a saline-based fluid strategy in the cardiac surgery patient. Design:A pragmatic blinded randomized controlled trial comparing starch-based with saline-based fluid strategy. Setting:A large tertiary academic center in London Ontario between September 2009 and February 2011. Participants:Patients undergoing planned, isolated coronary revascularization. Measurements:Serum creatinine and patient weight were measured daily postoperatively. Methods:Patients were randomized to receive 6% hydroxyethyl starch (Voluven) or saline for perioperative fluid requirements. Fluid administration was not protocolized. Co-primary outcomes were incidence of acute kidney injury (AKI) and maximum postoperative weight gain. Secondary outcomes included bleeding, transfusion, inotropic and ventilator support, and fluid utilization. Results:The study was prematurely terminated due to resource limitations. A total of 69 patients (19% female, mean age = 65) were randomized. Using RIFLE criteria for AKI, "risk" occurred in 12 patients in each group (risk ratio [RR] = 1.0; 95% confidence interval [CI] = 0.5-1.9; P = 1.00), whereas "injury" occurred in 7 of 35 (20%) and 3 of 34 (9%) of patients in the starch and saline groups, respectively (RR = 2.3; 95% CI = 0.6-8.1; P = .31). Maximum weight gain, bleeding and blood product usage, and overall fluid requirement were similar between groups. Limitations:The study had to be prematurely terminated due to resource limitations which led to a small sample size which was not sufficiently powered to detect a difference in the primary outcomes. Conclusions:This pragmatic double-blinded randomized controlled trial revealed a number of interesting hypothesis-generating trends and confirmed the feasibility of undertaking a logistically complex trial in a pragmatic fashion.

Project description:ObjectivesTo investigate if sevoflurane based anesthesia is superior to propofol in preventing lung inflammation and preventing postoperative pulmonary complications.DesignRandomized controlled trial.SettingSingle tertiary care university hospital.ParticipantsForty adults undergoing cardiac surgery with cardiopulmonary bypass.InterventionsPatients were randomized in a 1:1 ratio to anesthetic maintenance with sevoflurane or propofol.Measurements and main resultsBlood and bronchoalveolar lavage fluid was sampled before and after bypass to measure pulmonary inflammation using a biomarker panel. The change in bronchoalveolar lavage concentration of tumor necrosis factor alpha (TNFα) was the primary outcome. Secondary outcomes included lung inflammation defined as changes in other biomarkers and postoperative pulmonary complications. There were no significant differences between groups in the change in bronchoalveolar lavage TNFα concentration (median [IQR] change, 17.24 [1.11-536.77] v 101.51 [1.47-402.84] pg/mL, sevoflurane v propofol, p = 0.31). There was a significantly lower postbypass concentration of plasma interleukin 8 (median [IQR], 53.92 [34.5-55.91] v 66.92 [53.03-94.44] pg/mL, p = 0.04) and a significantly smaller postbypass increase in the plasma receptor for advanced glycosylation end products (median [IQR], 174.59 [73.59-446.06] v 548.22 [193.15-852.39] pg/mL, p = 0.03) in the sevoflurane group compared with propofol. The incidence of postoperative pulmonary complications was 100% in both groups, with high rates of pleural effusion (17/18 [94.44%] v 19/22 [86.36%], p = 0.39) and hypoxemia (16/18 [88.88%] v 22/22 [100%], p = 0.11).ConclusionsSevoflurane anesthesia during cardiac surgery did not consistently prevent lung inflammation or prevent postoperative pulmonary complications compared to propofol. There were significantly lower levels of 2 plasma biomarkers specific for lung injury and inflammation in the sevoflurane group.

Project description:BackgroundBlood-based cardioplegia is the standard myocardial protection strategy in pediatric cardiac surgery. Custadiol (histidine-tryptophan-ketoglutarate), an alternative, may have some advantages but is potentially less effective at myocardial protection. This study aimed to test whether custadiol is not inferior to blood-based cardioplegia in pediatric cardiac surgery.MethodsThe study was designed as a randomized controlled trial with a blinded outcome assessment. All pediatric patients undergoing cardiac surgery with cardiopulmonary bypass and cardioplegia, including neonates, were eligible. Emergency surgery was excluded. The primary outcome was a composite of death within 30 days, an ICU stay longer than 5 days, or arrhythmia requiring intervention. Secondary endpoints included total hospital stay, inotropic score, cardiac troponin levels, ventricular function, and extended survival postdischarge. The sample size was determined a priori for a noninferiority design with an expected primary outcome of 40% and a clinical significance difference of 20%.ResultsBetween January 2018 and January 2021, 226 patients, divided into the Custodiol cardioplegia (CC) group (n = 107) and the blood cardioplegia (BC) group (n = 119), completed the study protocol. There was no difference in the composite endpoint between the CC and BC groups, 65 (60.75%) vs. 71 (59.66%), respectively (P = 0.87). The total length of stay in the hospital was 14 (Q2-Q3: 10-19) days in the CC group vs. 13 (10-21) days in the BC group (P = 0.85). The inotropic score was not significantly different between the CC and BC groups, 5 (2.6-7.45) vs. 5 (2.6-7.5), respectively (P = 0.82). The cardiac troponin level and ventricular function did not differ significantly between the two groups (P = 0.34 and P = 0.85, respectively). The median duration of follow-up was 32.75 (Q2-Q3: 18.73-41.53) months, and there was no difference in survival between the two groups (log-rank P = 0.55).ConclusionsCustodial cardioplegia is not inferior to blood cardioplegia for myocardial protection in pediatric patients. Trial registration The trial was registered in Clinicaltrials.gov, and the ClinicalTrials.gov Identifier number is NCT03082716 Date: 17/03/2017.

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Reduction of drainage-associated complications in cardiac surgery with a digital drainage system: a randomized controlled trial.

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Reduction of drainage-associated complications in cardiac surgery with a digital drainage system: a randomized controlled trial.

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