Home-based management of hypoxaemic COVID-19 patients: design of the Therapy@Home pilot study.

INTRODUCTION: During the COVID-19 pandemic, hospital capacity was strained. Home-based care could relieve the hospital care system and improve patient well-being if safely organised.We designed an intervention embedded in a regional collaborative healthcare network for the home-based management of acutely ill COVID-19 patients requiring oxygen treatment. Here, we describe the design and pilot protocol for the evaluation of the feasibility of this complex intervention. METHODS AND ANALYSIS: Following a participatory action research approach, the intervention was designed in four consecutive steps: (1) literature review and establishment of an expert panel; (2) concept design of essential intervention building blocks (acute medical care, acute nursing care, remote monitoring, equipment and technology, organisation and logistics); (3) safety assessments (prospective risk analysis and a simulation patient evaluation) and (4) description of the design of the pilot (feasibility) study aimed at including approximately 15-30 patients, sufficient for fine-tuning for a large-scale randomised intervention. ETHICS AND DISSEMINATION: All patients will provide written, informed consent. The study was approved by the Medical Ethics Review Committee of the University Medical Center Utrecht, the Netherlands (protocol NL77421.041.21). The preparatory steps (1-4) needed to perform the pilot are executed and described in this paper. The findings of the pilot will be published in academic journals. If we consider the complex intervention feasible, we aim to continue with a large-scale randomised controlled study evaluating the clinical effectiveness, safety and implementation of the complex intervention.

VATS-assisted surgical stabilization of rib fractures in flail chest: 1-year follow-up of 105 cases.

OBJECTIVES: Early surgical stabilization of flail chest has been shown to improve chest wall stability and diminish respiratory complications. The addition of video­assisted thoracoscopic surgery (VATS) can diagnose and manage intrathoracic injuries and evacuate hemothorax. This study analyzed the outcome of our 7-year experience with VATS-assisted surgical stabilization of rib fractures (SSRF) for flail chest. METHODS: From January 2013 to December 2019, all trauma patients undergoing VATS-assisted SSRF for flail chest were included. Patient characteristics and complications during 1-year follow-up were reported. RESULTS: VATS­assisted SSRF for flail chest was performed in 105 patients. Median age was 65 years (range 21-92). Median injury severity score was 16 (range 9-49). Hemothorax was evacuated with VATS in 80 patients (median volume 200 ml, range 25-2500). In 3 patients entrapped lung was freed from the fracture site and in 2 patients a diaphragm rupture was repaired. Median postoperative ICU admission was 2 days (range 1-41). Thirty-two patients (30%) had a post­operative complication during admission and six patients (6%) a complication within 1 year. In-hospital mortality rate was 1%. Six patients (6%) died after discharge, due to causes unrelated to the original injury. CONCLUSIONS: Addition of VATS to SSRF for flail chest seems helpful to diagnose and manage intrathoracic injuries and adequately evacuate hemothorax. The majority of complications are low grade and occur during admission. Further prospective research needs to be conducted to identify potential risk factors for complications and better selection for addition of VATS to improve care in the future.

Surgical mediastinal lymph node staging for non-small-cell lung carcinoma.

BACKGROUND: The current preferred approach for surgical mediastinal staging of non-small-cell lung carcinoma is video-assisted mediastinoscopy. An alternative technique in which lymph nodes are resected instead of biopsied is video-assisted mediastinoscopic lymphadenectomy (VAMLA) that is suggested to be superior in detecting N2 disease. Yet, evidence is conflicting and furthermore limited by sample size. The objective was to compare mediastinal staging through VAMLA and video-assisted mediastinoscopy. METHODS: A single-center cohort study was conducted. All consecutive patients that underwent surgical mediastinal staging of non-small-cell lung carcinoma by VAMLA (2011 to 2018) were compared to historic video-assisted mediastinoscopy controls (2007 to 2011). Patients with negative surgical mediastinal staging underwent subsequent anatomical resection with systematic regional lymphadenectomy. Primary outcome was the sensitivity and negative predictive value for detecting N2 disease. RESULTS: Two-hundred-sixty-nine video-assisted mediastinoscopic lymphadenectomies and 118 video-assisted mediastinoscopies were performed. The prevalence of N2 disease was 20% and 26% respectively in the VAMLA and video-assisted mediastinoscopy group, while the rate of unforeseen pN2 resulting from lymph node dissection during anatomical resection was 4% and 11%, respectively. Invasive staging using VAMLA demonstrated superior sensitivity of 0.82 and a negative predictive value of 0.96 when compared to video-assisted mediastinoscopy (0.62 and 0.89, respectively), offering a 64% decrease in risk of unforeseen pN2 following anatomical resection. However, VAMLA is also associated with a 75% risk increase on complications (P=0.36). CONCLUSIONS: We conclude that performing invasive mediastinal lymph node assessment for staging of non-small-cell lung carcinoma, VAMLA should be the preferred technique with superior sensitivity and negative predictive value in detecting N2 disease. Though, VAMLA is also associated with an increased risk of complications.

The learning curve of video-assisted mediastinoscopic lymphadenectomy for staging of non-small-cell lung carcinoma.

OBJECTIVES: The objective of this study was to define the learning process of video-assisted mediastinoscopic lymphadenectomy (VAMLA) by the assessment of consecutive procedural metrics. METHODS: We conducted a single-centre retrospective observational study of all consecutive VAMLAs performed between 2011 and 2018 for the staging of non-small-cell lung carcinoma. Learning curves were assessed using non-risk adjusted cumulative observed minus expected (CUSUM) failure charts of complications. Boundary lines were defined by the acceptable and unacceptable complication rates of 4.5% and 15.0%. The Kruskal-Wallis test with post hoc analysis was used to assess trends in operation time and blood loss. RESULTS: Two-hundred-thirty-six unique VAMLAs by 4 surgeons performing their first procedures were evaluated. CUSUM charts of surgeons A and B showed a typical learning curve with an initial incline, followed by a turning point towards lower complications rates after 16-17 cases, whereas surgeons C and D showed an average performance. The median time between consecutive VAMLAs was shorter for surgeons A and B (13.0 vs 28.5-38.0 days for surgeons C and D). Overcoming the learning curve, complication rates of surgeons A and B decreased from 19% to 3% and from 18% to 5%, respectively. Operation time and blood loss showed a significant improvement after, respectively, 81-100 and 61-80 procedures compared to the first 20 procedures. CONCLUSIONS: VAMLA is a safe procedure to adopt and perform with acceptable complication rates from the first operation onward, regardless of the caseload. To overcome its learning curve, 16-17 cases are required, preferably at least 1 per 2 weeks.