Prognostication using SpO(2)/FiO(2) in invasively ventilated ICU patients with ARDS due to COVID-19-Insights from the PRoVENT-COVID study

Background: The SpO(2)/FiO(2) is a useful oxygenation parameter with prognostic capacity in patients with ARDS. We investigated the prognostic capacity of SpO(2)/FiO(2) for mortality in patients with ARDS due to COVID-19. Methods: This was a post-hoc analysis of a national multicenter cohort study in invasively ventilated patients with ARDS due to COVID-19. The primary endpoint was 28-day mortality. Results: In 869 invasively ventilated patients, 28-day mortality was 30.1%. The SpO(2)/FiO(2) on day 1 had no prognostic value. The SpO(2)/FiO(2) on day 2 and day 3 had prognostic capacity for death, with the best cut-offs being 179 and 199, respectively. Both SpO(2)/FiO(2) on day 2 (OR, 0.66 [95%-CI 0.46-0.96]) and on day 3 (OR, 0.70 [95%-CI 0.51-0.96]) were associated with 28-day mortality in a model corrected for age, pH, lactate levels and kidney dysfunction (AUROC 0.78 [0.76-0.79]). The measured PaO2/FiO(2) and the PaO2/FiO(2) calculated from SpO(2)/FiO(2) were strongly correlated (Spearman's r = 0.79). Conclusions: In this cohort of patients with ARDS due to COVID-19, the SpO(2)/FiO(2) on day 2 and day 3 are independently associated with and have prognostic capacity for 28-day mortality. The SpO(2)/FiO(2) is a useful metric for risk stratification in invasively ventilated COVID-19 patients. (C) 2021 The Authors. Published by Elsevier Inc

Ventilation and outcomes following robotic-assisted abdominal surgery: an international, multicentre observational study

Background: International data on the epidemiology, ventilation practice, and outcomes in patients undergoing abdominal robotic-assisted surgery (RAS) are lacking. The aim of the study was to assess the incidence of postoperative pulmonary complications (PPCs), and to describe ventilator management after abdominal RAS. Methods: This was an international, multicentre, prospective study in 34 centres in nine countries. Patients ≥18 yr of age undergoing abdominal RAS were enrolled between April 2017 and March 2019. The Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score was used to stratify for higher risk of PPCs (≥26). The primary outcome was the incidence of PPCs. Secondary endpoints included the preoperative risk for PPCs and ventilator management. Results: Of 1167 subjects screened, 905 abdominal RAS patients were included. Overall, 590 (65.2%) patients were at increased risk for PPCs. Meanwhile, 172 (19%) patients sustained PPCs, which occurred more frequently in 132 (22.4%) patients at increased risk, compared with 40 (12.7%) patients at lower risk of PPCs (absolute risk difference: 12.2% [95% confidence intervals (CI), 6.8–17.6%]; P<0.001). Plateau and driving pressures were higher in patients at increased risk, compared with patients at low risk of PPCs, but no ventilatory variables were independently associated with increased occurrence of PPCs. Development of PPCs was associated with a longer hospital stay. Conclusions: One in five patients developed one or more PPCs (chiefly unplanned oxygen requirement), which was associated with a longer hospital stay. No ventilatory variables were independently associated with PPCs. Clinical trial registration: NCT02989415

Spontaneous recovery of neuromuscular blockade is an independent risk factor for postoperative pulmonary complications after abdominal surgery: A secondary analysis

Abstract Background: In intermediate-to-high-risk patients, major abdominal surgery is associated with a high incidence of postoperative complications, mainly pulmonary. Neuromuscular blocking drugs have been suggested as a contributing factor, but this remains unproven. Objective: To define the relationship of neuromuscular blockade management (reversal) with postoperative pulmonary complications (PPCs). Design: The individualised PeRioperative Open-lung approach Versus standard protectivE ventilation in abdominal surgery study was a prospective, multicentre, four-arm, randomised controlled trial. This is a secondary analysis of the data. Setting: Twenty-one teaching hospitals in Spain. The study was conducted between 2 January 2015, and 18 May 2016. Patients: Age more than 18 years with an intermediate-to-high risk for PPCs, scheduled for major abdominal surgery lasting more than 2 h. Exclusion criteria included pregnancy or breastfeeding, and moderate-to-severe organ diseases. Interventions: The mode of reversal of neuromuscular blockade determined two patient groups: pharmacological reversal versus spontaneous recovery. Main outcome measures: The primary outcome was a composite of PPCs during the first 30 postoperative days. The association between categorical variables and PPCs within 30 days was studied. Univariate and multivariable logistic regression modelling and propensity score analyses were performed. Results: From the 923 patients included, 596 (64.6%) presented with PPCs within 30 days after surgery. Patients who developed these complications were older with a higher BMI, a lower pre-operative SpO2, a higher ASA physical status score and a higher incidence of arterial hypertension, diabetes mellitus or chronic obstructive pulmonary disease. Pharmacological neuromuscular blockade reversal was associated with a lower incidence of PPCs (odds ratio 0.62, 95% CI 0.47 to 0.82). Conclusion: Spontaneous recovery of neuromuscular blockade was an independent risk factor for PPCs in patients with intermediate-to-high risk, undergoing abdominal surgery. We suggest this factor should be included in future studies on PPCs.INSTITUTO SALUD CARLOS IIIEuropean Regional Development FundDepto. de Farmacología y ToxicologíaFac. de MedicinaTRUEpu

Radiofrecuencia pulsada del ganglio de la raíz dorsal torácico con catéter epidural. Un nuevo abordaje de un tratamiento efectivo

Pulsed radiofrequency (pRF) has been used for the treatment of peripheral nerves and the dorsal root ganglion (DRG). It has been commonly applied for the treatment of low back pain, neck pain and neuropathies with very good results. The dorsal root ganglion is an anatomical structure that is located bilaterally at the distal end of the dorsal root in the lateral epidural space. Most of the thoracic GRDs are located in the medial cranial part of the intervertebral foramina. Patients with thoracic pain radiated following a segmental pattern, which do not respond to conservative treatment, are susceptible to treatment by pRF from the DRG. In order to overcome the technical difficulties in access to thoracic GRD and to minimize the possible iatrogenic complications derived from the traditional percutaneous technique, we decided to perform the pRF technique in GRD at the thoracic level with epidural catheter by approaching the epidural space via translaminar in two patients with thoracic radiculopathy. Treatment of the dorsal root ganglion at the lumbar level is a widespread therapy in patients with chronic low back pain. Various studies and reviews support the realization of this technique. However, thoracic radicular pain is not a typical clinical syndrome such as in the lumbar area. There are different pain patterns: constant or intermittent pain, nociceptive or neuropathic pain or a combination of these. The PAIN DETECT questionnaire was specifically developed to detect the components of neuropathic pain in adults. Treatment of DRG using pRF with an epidural approach performed in the cases described has been shown to be effective. We obtained a good success rate with a decrease in NRS of more than 50% in both cases, with the practical disappearance of the neuropathic component of pain. The approach through the epidural canal via translaminar provides great safety emerging as an adequate option to decrease the rate of serious complications.La radiofrecuencia pulsada (RFp) se ha utilizado para el tratamiento de nervios periféricos y del ganglio de la raíz dorsal (GRD). Comúnmente se ha aplicado para tratamiento de dolor lumbar, cervical y neuropatías con muy buenos resultados. El ganglio de la raíz dorsal es una estructura anatómica que se encuentra situada bilateralmente en el extremo distal de la raíz dorsal en el espacio epidural lateral. La mayor parte de los GRD torácicos se localizan en la parte craneal medial de los agujeros intervertebrales. Los pacientes con dolor torácico irradiado siguiendo un patrón segmentario, que no responden al tratamiento conservador, son susceptibles de tratamiento mediante RFp del GRD. Con el objetivo de salvar las dificultades técnicas en el acceso al GRD torácico y de minimizar las posibles complicaciones yatrogénicas derivadas de la técnica percutánea tradicional, decidimos realizar la técnica de RFp en GRD a nivel torácico con catéter epidural mediante abordaje del espacio epidural vía translaminar en dos pacientes afectos de radiculopatía torácica. El tratamiento del ganglio de la raíz dorsal a nivel lumbar es una terapia muy extendida en pacientes con dolor crónico lumbar radicular. Diversos estudios y revisiones avalan la realización de esta técnica. Sin embargo, el dolor radicular torácico no es un síndrome clínico típico como en el área lumbar. Existen diferentes patrones dolorosos: dolor constante o intermitente, dolor nociceptivo o neuropático o una combinación de estos. El cuestionario de dolor "Pain detect" fue específicamente desarrollado para detectar los componentes del dolor neuropático en adultos. El tratamiento del GRD mediante RFp con abordaje epidural realizado en los casos descritos ha demostrado ser efectivo. Hemos obtenido una buena tasa de éxitos con una disminución en la EVN de más del 50 % en los dos casos, con la práctica desaparición del componente neuropático del dolor. El abordaje a través del canal epidural vía translaminar aporta gran seguridad emergiendo como una opción adecuada para disminuir la tasa de complicaciones graves

Prognostication using SpO2/FiO2 in invasively ventilated ICU patients with ARDS due to COVID-19 – Insights from the PRoVENT-COVID study

Background: The SpO2/FiO2 is a useful oxygenation parameter with prognostic capacity in patients with ARDS. We investigated the prognostic capacity of SpO2/FiO2 for mortality in patients with ARDS due to COVID–19. Methods: This was a post-hoc analysis of a national multicenter cohort study in invasively ventilated patients with ARDS due to COVID–19. The primary endpoint was 28–day mortality. Results: In 869 invasively ventilated patients, 28–day mortality was 30.1%. The SpO2/FiO2 on day 1 had no prognostic value. The SpO2/FiO2 on day 2 and day 3 had prognostic capacity for death, with the best cut-offs being 179 and 199, respectively. Both SpO2/FiO2 on day 2 (OR, 0.66 [95%–CI 0.46–0.96]) and on day 3 (OR, 0.70 [95%–CI 0.51–0.96]) were associated with 28–day mortality in a model corrected for age, pH, lactate levels and kidney dysfunction (AUROC 0.78 [0.76–0.79]). The measured PaO2/FiO2 and the PaO2/FiO2 calculated from SpO2/FiO2 were strongly correlated (Spearman's r = 0.79). Conclusions: In this cohort of patients with ARDS due to COVID–19, the SpO2/FiO2 on day 2 and day 3 are independently associated with and have prognostic capacity for 28–day mortality. The SpO2/FiO2 is a useful metric for risk stratification in invasively ventilated COVID–19 patients.</p

Association of time-varying intensity of ventilation with mortality in patients with COVID-19 ARDS: Secondary analysis of the PRoVENT-COVID Study

Background: High intensity of ventilation has an association with mortality in patients with acute respiratory failure. It is uncertain whether similar associations exist in patients with acute respiratory distress syndrome (ARDS) patients due to coronavirus disease 2019 (COVID−19). We investigated the association of exposure to different levels of driving pressure (ΔP) and mechanical power (MP) with mortality in these patients. Methods: PRoVENT–COVID is a national, retrospective observational study, performed at 22 ICUs in the Netherlands, including COVID−19 patients under invasive ventilation for ARDS. Dynamic ΔP and MP were calculated at fixed time points during the first 4 calendar days of ventilation. The primary endpoint was 28–day mortality. To assess the effects of time–varying exposure, Bayesian joint models adjusted for confounders were used. Results: Of 1,122 patients included in the PRoVENT–COVID study, 734 were eligible for this analysis. In the first 28 days, 29.2% of patients died. A significant increase in the hazard of death was found to be associated with each increment in ΔP (HR 1.04, 95% CrI 1.01–1.07) and in MP (HR 1.12, 95% CrI 1.01–1.36). In sensitivity analyses, cumulative exposure to higher levels of ΔP or MP resulted in increased risks for 28–day mortality. Conclusion: Cumulative exposure to higher intensities of ventilation in COVID−19 patients with ARDS have an association with increased risk of 28–day mortality. Limiting exposure to high ΔP or MP has the potential to improve survival in these patients. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04346342

The fragility of statistically significant findings in randomised controlled anaesthesiology trials: systematic review of the medical literature

The fragility index (FI), the number of events the statistical significance a result depends on, and the number of patients lost to follow-up are important parameters for interpreting randomised clinical trial results. We evaluated these two parameters in randomised controlled trials in anaesthesiology. For this, we performed a systematic search of the medical literature, seeking articles reporting on anaesthesiology trials with a statistically significant difference in the primary outcome and published in the top five general medicine journals, or the top 15 anaesthesiology journals. We restricted the analysis to trials reporting clinically important primary outcome measures. The search identified 139 articles, 35 published in general medicine journals and 104 in anaesthesiology journals. The median (inter-quartile range) sample size was 150 (70–300) patients. The FI was 4 (2–17) and 3 (2–7), and the number of patients lost to follow-up was 0 (0–18) and 0 (0–6) patients in trials published in general medicine and anaesthesiology journals, respectively. The number of patients lost to follow-up exceeded the FI in 41 and 27% in trials in general medicine journals and anaesthesiology journals, respectively. The FI positively correlated with sample size and number of primary outcome events, and negatively correlated with the reported P-values. The results of this systematic review suggest that statistically significant differences in randomised controlled anaesthesiology trials are regularly fragile, implying that the primary outcome status of patients lost to follow-up could possibly have changed the reported effect