ABSTRACT
Background: Guidelines for long-term ventilation agree that tracheotomy has several benefits for patien t treatment . During the coronavirus disease-19 (COVID-19) pandemic it is widely seen as an unsafe procedure with a high risk of infection. To assess the risk, we used a mathematical model and assessed our tracheotomies in COVID-19 patients. Material(s) and Method(s): First, theoretical risk of infectio n durin g tracheotomy was assessed using a Monte-Carlo (MC) simulation of airborne transmission based on the Wells-Riley equation. Second, we evaluated early tracheotomies performed in 16 COVID-19 patients. Tracheotomies were performed by experienced ICU physicians and trainees under supervision. Personal protective equipment (PPE) was used in all procedures. Patients or legal representatives gave informed consent to the procedure. Result(s): Our theoretical model revealed a risk of infection between 0.08 +/- 0.03% and 2.5 +/- 0.8%, depending on the assumptions made. MC simulations showed that the stochastic risk of infection is low to very low, if PPE is correctly used. Patients were a mean of 61 years old (median age 60 +/- 7 years;15/16 male), mean BMI was 31.3 kg/m2 (median 29.6 +/- 6.9 kg/m2). All procedures were percutaneous dilatation tracheotomies (PDT). There was no procedure-related complication or death due to tracheotomy. Overall mortality in COVID-19 patients undergoing tracheotomy was 6 out of 16 (37.5%). No SARS-CoV-2 infections were recorded in 59 tracheotomy-performing healthcare workers (HCW) or other team members. Conclusion(s): The theoretical risk of infections during tracheotomy is low. Technically, tracheotomy in COVID-19 patients is almost identical to patients without COVID-19, the only difference being PPE during the intervention Copyright ©.
ABSTRACT
Background: Several observational studies suggested efficacy of COVID-19 convalescent plasma (CCP) but the results of several randomized clinical trials of CCP are not consistent. The trials differ in treatment schedules in terms of timing, volume and antibody content of CCP as well as enrolled patient populations and endpoints. The CAPSID was designed at the beginning of the pandemic and assessed the efficacy of neutralizing antibody containing high-dose COVID-19 convalescent plasma (CCP) in hospitalized patients with severe COVID-19. Methods: Patients (n=105) in 13 hospitals in Germany were randomized to either receive standard treatment and three units of CCP on days 1, 3 and 5 (total dose 846 ml) (n=53) or standard treatment alone (n=52). Patients in the control group with progress on day 14 could receive CCP (crossover group;n=7) on days 15, 17 and 19. The primary outcome was a dichotomous composite outcome of survival and no longer fulfilling criteria of severe COVID-19 on day 21. For Cross over patients a propensity matching with patients of the plasma group was performed. Results: Neutralizing antibodies were present at baseline in 18.2% of CCP and 19.2% of control group patients. In the ITT analysis the primary outcome occurred in 43.4% of patients in the CCP and 32.7% in the control group (p=0.32). The CCP group showed a trend for shorter times to clinical improvement (40 days, p=0.27) and discharge from hospital (20 days, p=0.24). Among those in the CCP group who received a higher or lower cumulative amount of neutralizing antibodies the primary outcome occurred in 56.0% and 32.1% of patients The high titer group showed significantly shorter intervals to clinical improvement or hospital discharge and a better overall survival (p=0.02). None of the patients in the crossover group (CG) achieved clinical improvement and survived. Comparing the CG to 14 CCP patients matched by baseline characteristics resulted in worse OS in the CG group (p=0.02) while comparison with 6 day 14 matched patients showed equal OS. Interpretation: CCP added to standard treatment did not result in a significant difference in the primary and secondary outcomes. A pre-defined subgroup analysis showed a signal of benefit for CCP among those who received a larger amount of neutralizing antibodies. A progress on day 14 is an indicator for poor outcome in COVID-19. Late administration of CCP is not supported by our results.
ABSTRACT
RATIONALE There is ongoing dispute whether COVID-19 related Acute Respiratory Distress Syndrome (CARDS) has unique physiology, setting it apart from 'classic' ARDS. While ECMO has proven valuable in the treatment of acute lung failure, little is known about when and how it should be used to support critically ill COVID-19 patients. METHODS We performed an international email survey to assess how ECMO providers worldwide have previously used ECMO during the treatment of critically ill patients with COVID-19. Questions targeted indications to begin ECMO, technical specifications, anticoagulation strategy and reasons for treatment discontinuation. RESULTS 276 centers worldwide responded that they employed ECMO for very severe COVID-19 cases, mostly in veno-venous configuration (87%). The most common reason to establish ECMO was isolated hypoxemic respiratory failure (50%), followed by a combination of hypoxemia and hypercapnia (39%). Only a small fraction of patients required veno-arterial cannulation due to heart failure (3%). Time on ECMO varied between less than two and more than four weeks. The main reason to discontinue ECMO treatment prior to patient's recovery was lack of clinical improvement (53%), followed by major bleeding, mostly intracranially (13%). Only 4% of respondents reported that triage situations, lack of staff or lack of oxygenators were responsible for the discontinuation of ECMO support. Most ECMO physicians (66% ± 26%) agreed that patients with COVID-19 induced ARDS benefitted from ECMO. Overall mortality of COVID-19 patients on ECMO was estimated to be about 55%, scoring higher than what has previously been reported for Influenza patients on ECMO (29-36%). Most ECMO providers agreed that, while COVID-19 patients were longer on ECMO compared to patients with ARDS of different origin, supposed hypercoagulation was hardly an issue during ECMO therapy and oxygenator change was not required more frequently than they were used to. CONCLUSION ECMO has been utilized successfully during the COVID-19 pandemic to stabilize CARDS patients in hypoxemic or hypercapnic lung failure, despite initial recommendations from scientific societies were mostly reluctant. Age and multimorbidity limited the use of ECMO. Triage situations were rarely a concern. ECMO providers stated that patients with severe COVID-19 benefitted from ECMO. An increasing use in patients with respiratory failure in a future stage of the pandemic may be expected. Early apprehensions that COVID-19 related hypercoagulation would result in severe thromboembolic complications during extracorporeal circulation were mostly mitigated judging from survey experience.
Subject(s)
Anti-Inflammatory Agents/therapeutic use , Coronavirus Infections/drug therapy , Coronavirus/isolation & purification , Dexamethasone/therapeutic use , Pandemics , Pneumonia, Viral/drug therapy , Practice Guidelines as Topic , Betacoronavirus , COVID-19 , Coronavirus Infections/diagnosis , Germany , Humans , Pneumonia, Viral/diagnosis , SARS-CoV-2 , Societies, Medical , Treatment Outcome , COVID-19 Drug TreatmentABSTRACT
Against the background of the pandemic caused by infection with the SARS-CoV-2, the German Society for Pneumology and Respiratory Medicine (DGP e.V.), in cooperation with other associations, has designated a team of experts in order to answer the currently pressing questions about therapy strategies in dealing with COVID-19 patients suffering from acute respiratory insufficiency (ARI).The position paper is based on the current knowledge that is evolving daily. Many of the published and cited studies require further review, also because many of them did not undergo standard review processes.Therefore, this position paper is also subject to a continuous review process and will be further developed in cooperation with the other professional societies.This position paper is structured into the following five topics:1. Pathophysiology of acute respiratory insufficiency in patients without immunity infected with SARS-CoV-22. Temporal course and prognosis of acute respiratory insufficiency during the course of the disease3. Oxygen insufflation, high-flow oxygen, non-invasive ventilation and invasive ventilation with special consideration of infectious aerosol formation4. Non-invasive ventilation in ARI5. Supply continuum for the treatment of ARIKey points have been highlighted as core statements and significant observations. Regarding the pathophysiological aspects of acute respiratory insufficiency (ARI), the pulmonary infection with SARS-CoV-2 COVID-19 runs through three phases: early infection, pulmonary manifestation and severe hyperinflammatory phase.There are differences between advanced COVID-19-induced lung damage and those changes seen in Acute Respiratory Distress Syndromes (ARDS) as defined by the Berlin criteria. In a pathophysiologically plausible - but currently not yet histopathologically substantiated - model, two types (L-type and H-type) are distinguished, which correspond to an early and late phase. This distinction can be taken into consideration in the differential instrumentation in the therapy of ARI.The assessment of the extent of ARI should be carried out by an arterial or capillary blood gas analysis under room air conditions and must include the calculation of the oxygen supply (measured from the variables of oxygen saturation, the Hb value, the corrected values of the Hüfner number and the cardiac output). In principle, aerosols can cause transmission of infectious viral particles. Open systems or leakage systems (so-called vented masks) can prevent the release of respirable particles. Procedures in which the invasive ventilation system must be opened, and endotracheal intubation must be carried out are associated with an increased risk of infection.The protection of personnel with personal protective equipment should have very high priority because fear of contagion must not be a primary reason for intubation. If the specifications for protective equipment (eye protection, FFP2 or FFP-3 mask, gown) are adhered to, inhalation therapy, nasal high-flow (NHF) therapy, CPAP therapy or NIV can be carried out according to the current state of knowledge without increased risk of infection to the staff. A significant proportion of patients with respiratory failure presents with relevant hypoxemia, often also caused by a high inspiratory oxygen fraction (FiO2) including NHF, and this hypoxemia cannot be not completely corrected. In this situation, CPAP/NIV therapy can be administered under use of a mouth and nose mask or a respiratory helmet as therapy escalation, as long as the criteria for endotracheal intubation are not fulfilled.In acute hypoxemic respiratory insufficiency, NIV should be performed in an intensive care unit or in a comparable unit by personnel with appropriate expertise. Under CPAP/NIV, a patient can deteriorate rapidly. For this reason, continuous monitoring with readiness to carry out intubation must be ensured at all times. If CPAP/NIV leads to further progression of ARI, intubation and subsequent invasive ventilation should be carried out without delay if no DNI order is in place.In the case of patients in whom invasive ventilation, after exhausting all guideline-based measures, is not sufficient, extracorporeal membrane oxygenation procedure (ECMO) should be considered to ensure sufficient oxygen supply and to remove CO2.