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Use of Smart Technology for the Early Diagnosis of Complications After Cardiac Surgery: The Box 2.0 Study Protocol.

ABSTRACT: BACKGROUND:Atrial fibrillation (AF), sternal wound infection, and cardiac decompensation are complications that can occur after cardiac surgery. Early detection of these complications is clinically relevant, as early treatment is associated with better clinical outcomes. Remote monitoring with the use of a smartphone (mobile health [mHealth]) might improve the early detection of complications after cardiac surgery. OBJECTIVE:The primary aim of this study is to compare the detection rate of AF diagnosed with an mHealth solution to the detection rate of AF diagnosed with standard care. Secondary objectives include detection of sternal wound infection and cardiac decompensation, as well as assessment of quality of life, patient satisfaction, and cost-effectiveness. METHODS:The Box 2.0 is a study with a prospective intervention group and a historical control group for comparison. Patients undergoing cardiac surgery at Leiden University Medical Center are eligible for enrollment. In this study, 365 historical patients will be used as controls and 365 other participants will be asked to receive either The Box 2.0 intervention consisting of seven home measurement devices along with a video consultation 2 weeks after discharge or standard cardiac care for 3 months. Patient information will be analyzed according to the intention-to-treat principle. The Box 2.0 devices include a blood pressure monitor, thermometer, weight scale, step count watch, single-lead electrocardiogram (ECG) device, 12-lead ECG device, and pulse oximeter. RESULTS:The study started in November 2018. The primary outcome of this study is the detection rate of AF in both groups. Quality of life is measured with the five-level EuroQol five-dimension (EQ-5D-5L) questionnaire. Cost-effectiveness is calculated from a society perspective using prices from Dutch costing guidelines and quality of life data from the study. In the historical cohort, 93.9% (336/358) completed the EQ-5D-5L and patient satisfaction questionnaires 3 months after cardiac surgery. CONCLUSIONS:The rationale and design of a study to investigate mHealth devices in postoperative cardiac surgery patients are presented. The first results are expected in September 2020. TRIAL REGISTRATION:ClinicalTrials.gov NCT03690492; http://clinicaltrials.gov/show/NCT03690492. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16326.

SUBMITTER: Biersteker TE

PROVIDER: S-EPMC7201318 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Use of Smart Technology for the Early Diagnosis of Complications After Cardiac Surgery: The Box 2.0 Study Protocol.

Biersteker Tom E TE Boogers Mark J MJ de Lind van Wijngaarden Robert Af RA Groenwold Rolf Hh RH Trines Serge A SA van Alem Anouk P AP Kirchhof Charles Jhj CJ van Hof Nicolette N Klautz Robert Jm RJ Schalij Martin J MJ Treskes Roderick W RW

JMIR research protocols 20200421 4

<h4>Background</h4>Atrial fibrillation (AF), sternal wound infection, and cardiac decompensation are complications that can occur after cardiac surgery. Early detection of these complications is clinically relevant, as early treatment is associated with better clinical outcomes. Remote monitoring with the use of a smartphone (mobile health [mHealth]) might improve the early detection of complications after cardiac surgery.<h4>Objective</h4>The primary aim of this study is to compare the detectio ...[more]

PMID: 32314974

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Project description:IntroductionContinually rising life expectancy and a shift towards an ageing population are resulting in an increasing population of nonagenarians. By 2030, the global population of nonagenarians is expected to exceed 30 million. The incidence of symptomatic cardiac disease is reported to occur in 25% of those aged over 75 years. Therefore, the number of nonagenarians undergoing cardiac surgery is also expected to increase. A linear relationship between advanced age and surgical risk has previously been demonstrated; however, it is not yet known whether this knowledge extends to the perioperative course and mortality of nonagenarians undergoing cardiac surgery. This scoping review aims to review the literature, assess whether a deficiency exists in the published literature and potentially identify knowledge gaps to guide future efforts to improve the understanding of nonagenarians undergoing cardiac surgery.Methods and analysisFollowing the relevant aspects of the Preferred Reporting Items for Systematic Review and Meta-Analysis Extension for Scoping Review guidelines, electronic databases of MEDLINE, EMBASE and the Cochrane Library will be systematically searched, with additional reference tracking of eligible studies. Studies reporting the outcomes of nonagenarians undergoing open cardiac surgery or minimally invasive cardiac surgery requiring cardiopulmonary bypass will be included. Screening and data extraction will be performed by two reviewers independently. The data will be analysed and summarised descriptively with a narrative approach. Qualitative data that capture quality-of-life outcomes will be subjected to thematic analysis where feasible. Additionally, reporting results will highlight similarities and differences in nonagenarian selection for surgery.Ethics and disseminationEthics approval was not required. The findings will be disseminated through professional networks, conference presentations and publications in scientific journals.

Project description:INTRODUCTION:Following cardiac surgery, patients currently attend an outpatient review 6?weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8?weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier. METHODS AND ANALYSES:This is a multicentre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18-80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres. Feasibility will be measured by consent, recruitment, retention rates and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial. ETHICS AND DISSEMINATION:Ethics approval was granted by East Midlands-Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders. TRIAL REGISTRATION NUMBER:ISRCTN80441309.

Project description:BackgroundCompared with historic ventilation strategies, modern lung-protective ventilation includes lower tidal volumes (VT), lower driving pressures, and application of positive end-expiratory pressure (PEEP). The contributions of each component to an overall intraoperative protective ventilation strategy aimed at reducing postoperative pulmonary complications have neither been adequately resolved, nor comprehensively evaluated within an adult cardiac surgical population. The authors hypothesized that a bundled intraoperative protective ventilation strategy was independently associated with decreased odds of pulmonary complications after cardiac surgery.MethodsIn this observational cohort study, the authors reviewed nonemergent cardiac surgical procedures using cardiopulmonary bypass at a tertiary care academic medical center from 2006 to 2017. The authors tested associations between bundled or component intraoperative protective ventilation strategies (VT below 8 ml/kg ideal body weight, modified driving pressure [peak inspiratory pressure - PEEP] below 16 cm H2O, and PEEP greater than or equal to 5 cm H2O) and postoperative outcomes, adjusting for previously identified risk factors. The primary outcome was a composite pulmonary complication; secondary outcomes included individual pulmonary complications, postoperative mortality, as well as durations of mechanical ventilation, intensive care unit stay, and hospital stay.ResultsAmong 4,694 cases reviewed, 513 (10.9%) experienced pulmonary complications. After adjustment, an intraoperative lung-protective ventilation bundle was associated with decreased pulmonary complications (adjusted odds ratio, 0.56; 95% CI, 0.42-0.75). Via a sensitivity analysis, modified driving pressure below 16 cm H2O was independently associated with decreased pulmonary complications (adjusted odds ratio, 0.51; 95% CI, 0.39-0.66), but VT below 8 ml/kg and PEEP greater than or equal to 5 cm H2O were not.ConclusionsThe authors identified an intraoperative lung-protective ventilation bundle as independently associated with pulmonary complications after cardiac surgery. The findings offer insight into components of protective ventilation associated with adverse outcomes and may serve as targets for future prospective interventional studies investigating the impact of specific protective ventilation strategies on postoperative outcomes after cardiac surgery.

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Use of Smart Technology for the Early Diagnosis of Complications After Cardiac Surgery: The Box 2.0 Study Protocol.

Publications

Use of Smart Technology for the Early Diagnosis of Complications After Cardiac Surgery: The Box 2.0 Study Protocol.

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