Self-contamination following removal of two personal protective equipment suits: a randomized, controlled, crossover simulation trial.

BACKGROUND: Healthcare personnel are often at high risk of contamination when participating in airway management and other aerosol-generating procedures. AIM: To explore the differences in self-contamination after removal of gown and coverall personal protective equipment (PPE) using an ultraviolet-fluorescent solution. METHODS: This prospective, randomized, controlled crossover trial was set in a third-level university health centre in Buenos Aires, Argentina between August and October 2020. The study included 60 anaesthesia personnel volunteers, and no participants were excluded from the study. A two-period/two-intervention design was chosen; each intervention comprised audio-guided placement of PPE, full-body spraying of fluorescent solution, audio-guided removal of PPE, and self-contamination assessment through ultraviolet light scanning. The primary outcome was the mean within-participant difference (any traces) between PPE suits. Statistical significance was tested using t-tests for paired data. The allocation ratio was 25/35 (gown followed by coverall/coverall followed by gown). FINDINGS: Self-contamination after removal of coveralls was greater than that after removal of gowns, with a mean within-participant difference of 11.45 traces (95% confidence interval 8.26-14.635; P<0.001). Significant differences were found for the number of self-contaminated body zones, small fluorescent traces and large fluorescent traces. Removal of a gown was associated with a markedly lower risk of self-contamination. CONCLUSIONS: Quick one-step removal of a gown and gloves may reduce self-contamination in the arm/hand area. Fluorescent solutions can help to identify self-contamination and compare outcomes between available PPE suits. Repeated training sessions and enhanced knowledge on self-contamination following removal of PPE are paramount. CLINICAL TRIAL REGISTRATION NUMBER: NCT04763304 (on ClinicalTrials.gov).

Brief guideline for the prevention of COVID-19 infection in head and neck and otolaryngology surgeons.

IMPORTANCE: Anatomically, viral density is greater in the nasal cavity and the nasopharynx. It is to be expected that instrumentation in or through those areas will entail a higher risk of transmission. That's why head and neck and otolaryngologist surgeons are among the most vulnerable health professionals. OBSERVATIONS: Surgeons should essentially perform procedures they require. Surgeries should be performed with personal protective equipment suitable for the high risk of aerosolization: goggles, N95 face mask, facial mask, blood-repelling gown and gloves. It is advisable to have the cooperative COVID-19 test in all patients. Telemedicine is a useful resource if resources allow it. CONCLUSIONS AND RELEVANCE: Otolaryngologists and related specialists are among the groups at higher risk when performing surgeries and upper airway examinations. There are no emergencies in a pandemic. The care of health professionals is crucial to combating this health situation.

Nausea and vomiting in a colorectal ERAS program: Impact on nutritional recovery and the length of hospital stay.

BACKGROUND & AIMS: Postoperative nausea and vomiting (PONV) and its impact on the hospital length of stay (LOS), have been extensively studied. However, most previous publications focused their studies on PONV during the first 24 h, and less is known about this complication during the ensuing days, its impact on nutritional recovery or its relation to other complications and the course of care. METHODS: An observational study involving 806 consecutive patients in a colorectal Enhanced Recovery After Surgery (ERAS) programme was performed. The primary objective was to analyse the incidence of early PONV on the day of surgery and the following 2 postoperative days (late PONV). Secondary objectives included evaluation of the influence of late PONV over the LOS and the nutritional recovery adjusted for confounding factors. RESULTS: PONV tended to increase over time (7% vs 7% and 10%, postop days 0, 1 and 2, respectively; p < 0.05). PONV on day 2 was associated in an adjusted analysis with poor oral intake, delayed solid food tolerance and an average increase in LOS of 2 nights. Risk factors for the presence of PONV on day 2 were the use of opioids on the same day, PONV on the day of the surgery and rectal procedures. CONCLUSIONS: PONV continues to be frequent after the first 24 h in colorectal surgery despite high compliance to current anti emetic recommendations. PONV during day 2 negatively affects the nutritional postoperative recovery and independently prolongs the hospital stay. The findings of the current study highlight the adverse effects of opioids and the need of further discussion on how to best audit, prevent and treat late PONV in ERAS colorectal programmes.

Ensayo clínico de eficacia del bloqueo bloqueo del plano transverso del abdomen ecoguiado en la histerectomía laparoscópica / Efficacy of ultrasound-guided transversus abdominis plane block in laparoscopic hysterectomy. Clinical trial

Objetivos. El bloqueo del plano transverso abdominal es una técnica de anestesia regional que demostró ser efectiva en cirugía abdominal abierta y laparoscópica como parte de un esquema de tratamiento del dolor postoperatorio. La presente investigación evaluó su eficacia en cirugía de histerectomía total laparoscópica. Materiales y métodos. El estudio fue diseñado como un ensayo clínico controlado, aleatorizado en 2 ramas: grupo protocolo bloqueo del plano transverso abdominal+analgesia intravenosa (Grupo 1; n=20) versus grupo protocolo analgesia intravenosa (Grupo 2; n=20), simple ciego que incluyó a 40 pacientes sometidas a una histerectomía total laparoscópica programada. Consumo de opioides en las primeras 24h del postoperatorio (mg de morfina), intensidad del dolor por escala verbal numérica a los 60min, 2, 8 y 24h posteriores a la cirugía, efectos adversos relacionados con la medicación administrada, calidad del sueño en la primera noche poscirugía y tiempo hasta el alta hospitalaria fueron evaluados y registrados. Resultados. No hubo diferencias estadísticamente significativas entre ambos grupos en cuanto al consumo de opioides (10mg vs. 7mg; p=0,2) y en las escalas de dolor por EVN postoperatorias a los 60min (3 vs. 5; p=0,65), 120min (0 vs. 2; p=0,15), 8 y 24h (0 vs. 0; p>0,50), en estos 2 últimos puntos de tiempo evaluados. Tampoco se hallaron diferencias respecto a la incidencia de efectos adversos, calidad de sueño en la primera noche después de la cirugía ni en el tiempo hasta el alta hospitalaria. Conclusiones. El bloqueo del plano transverso abdominal parece no aportar ningún beneficio adicional respecto a un plan de analgesia con opioides tipo PCA empleado en cirugía laparoscópica ginecológica, prolongando los tiempos de preparación del paciente, agregando un riesgo eventual (aunque bajo) de complicaciones e incrementando los costos (AU)

Objectives. Transversus abdominis plane block is a regional anaesthesia technique that has proven to be effective for postoperative pain reduction in different abdominal surgical procedures. This study evaluated its efficacy on post laparoscopic hysterectomy pain intensity and analgesic consumption. Materials and methods. Randomized controlled trial which included 40 patients scheduled for laparoscopic hysterectomy, enrolled in 2 groups: transversus abdominis plane block+systemic analgesia (Group 1; n=20), versus systemic analgesia (Group 2; n=20). Opioid consumption within the first 24 postoperative hours, pain intensity scores at 60min, 2, 8 and 24h after surgery, adverse events related to systemic analgesia and time to hospital discharge were evaluated and registered. Results. We found no differences between both groups in opioid consumption (10mg vs. 7mg; P=.2) and pain scores (NVS) within the first 24 postoperative hours, at 60min (3 vs. 5; P=.65), 120min (0 vs. 2; P=.15), 8 and 24h (0 vs. 0; P>.50) for the last 2 points in time analysed. Adverse events related to medication and time to hospital discharge showed similar results. Conclusions. Adding a transversus abdominis plane block technique to opioid PCA does not seem to improve postoperative pain management in laparoscopic hysterectomy. Patient preparation time and costs could be incremented and complications (although rare) related to the technique could appear (AU)

Efficacy of ultrasound-guided transversus abdominis plane block in laparoscopic hysterectomy. Clinical trial. / Ensayo clínico de eficacia del bloqueo bloqueo del plano transverso del abdomen ecoguiado en la histerectomía laparoscópica.

OBJECTIVES: Transversus abdominis plane block is a regional anaesthesia technique that has proven to be effective for postoperative pain reduction in different abdominal surgical procedures. This study evaluated its efficacy on post laparoscopic hysterectomy pain intensity and analgesic consumption. MATERIALS AND METHODS: Randomized controlled trial which included 40 patients scheduled for laparoscopic hysterectomy, enrolled in 2 groups: transversus abdominis plane block+systemic analgesia (Group 1; n=20), versus systemic analgesia (Group 2; n=20). Opioid consumption within the first 24 postoperative hours, pain intensity scores at 60min, 2, 8 and 24h after surgery, adverse events related to systemic analgesia and time to hospital discharge were evaluated and registered. RESULTS: We found no differences between both groups in opioid consumption (10mg vs. 7mg; P=.2) and pain scores (NVS) within the first 24 postoperative hours, at 60min (3 vs. 5; P=.65), 120min (0 vs. 2; P=.15), 8 and 24h (0 vs. 0; P>.50) for the last 2 points in time analysed. Adverse events related to medication and time to hospital discharge showed similar results. CONCLUSIONS: Adding a transversus abdominis plane block technique to opioid PCA does not seem to improve postoperative pain management in laparoscopic hysterectomy. Patient preparation time and costs could be incremented and complications (although rare) related to the technique could appear.

Intraoperative use of several inotropes is associated with increased mid-term mortality in patients undergoing orthotopic heart transplantation.

INTRODUCTION: Orthotopic heart transplantation (OHT) is the gold standard treatment for patients with end-stage heart failure. Inotropic agents are the hemodynamic mainstay in the treatment of implanted donor hearts. However, their infusion, particularly in excess, can have unintended consequences that lead to cardiac toxicity and can originate malignant arrhythmias, myocardial necrosis, and myocyte apoptosis. OBJECTIVE: The aim of the study was to determine the perioperative predictors of mid-term mortality after OHT. METHODS: We retrospectively studied all consecutive adult patients who underwent OHT between January 2009 and July 2013 at a tertiary care university hospital and followed them up until July 2013. Donor and recipient demographic data, hemodynamic profile, and perioperative data were analyzed. The primary endpoint was mid-term survival. RESULTS: The overall survival rate was 80.6% during hospitalization time and 70.1% after 328 (interquartile range, 643) days of follow-up. The univariate analysis showed that patients who died were older, had lower height and body surface area, donor/recipient (D/R) mismatch, prior cardiac surgery, longer cardiopulmonary bypass (CPB) time, postoperative lower left ventricular ejection fraction, sepsis, and primary graft dysfunction. Using Cox survival analysis, the independent risk factors related to mid-term mortality were intraoperative use of more than 2 inotropic drugs (hazard ratio [HR], 3.887; 95% confidence interval [CI], 1.224-12.342; P = .021), CPB duration (HR, 1.008; 95% CI, 1.003-1.014; P = .002), and D/R weight ratio (HR, 1.027; 95% CI, 1.009-1.046; P = .003). CONCLUSION: In patients undergoing OHT, mid-term survival was mostly related to D/R weight mismatch and intraoperative factors, mainly inotropic drugs and CPB duration.

Phase I dose-escalation study of brostallicin, a minor groove binder, in combination with cisplatin in patients with advanced solid tumors.

PURPOSE: Brostallicin is a DNA minor groove binder which shows enhanced antitumor activity in cells which are resistant to several anticancer agents due to their high glutathione S-transferase (GST)/glutathione content. Phase I and II clinical trials of single-agent brostallicin have shown that myelotoxicity is the dose-limiting toxicity (DLT), while hints of antitumor activity were mainly observed in soft tissue sarcoma. Preclinical studies showing a more than additive antitumor effect of the cisplatin-brostallicin combination paved the way to clinical combination studies. In particular, we set up the first clinical combination study of brostallicin and cisplatin in patients with advanced solid tumors. This study was to be followed by a phase II study in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN). METHODS: Escalating doses of brostallicin were administered in combination with a fixed dose of cisplatin (75 mg/m(2)) in patients with recurrent or metastatic advanced solid tumors who had previously received a cumulative dose of cisplatin not higher than 475 mg/m(2). The recommended dose of brostallicin was expanded in order to have a better estimate of antitumor activity and to better define the safety profile of the combination. RESULTS: Twenty-one patients were treated. Two DLTs (grade 3 fatigue and febrile neutropenia) were observed at dose level 3 (brostallicin 9 mg/m(2)). Dose level 2 (brostallicin 7 mg/m(2) and cisplatin 75 mg/m(2)) was recommended for future phase II studies. Main toxicity was hematologic; in fact, only 1 patient out of 21 did not develop neutropenia and only 2 patients did not have thrombocytopenia. Grade 3-4 neutropenia was observed in 90.5% of patients, grade 3-4 thrombocytopenia in 38.1%, grade 3-4 anemia in 23.8%. The cycle 1 nadir (ANC < 500 x 10(9)/L) for neutrophils was Day 14 (median; range 11-17) with recovery to an ANC of >1,500 3.5 days after nadir (median; range 2-4) at dose level 3. The cycle 1 nadir (median of 51,000 x 10(9)/L) for platelets occurred on Day 13 (median; range 10-15) with recovery to a platelet count of >100,000 4 days after nadir (median; range 2-8). No objective responses were observed, but seven patients had a long lasting (>18 weeks) stable disease. CONCLUSIONS: Further studies of the combination of brostallicin and cisplatin are warranted.

[Thrombotic microangiopathy during urinary tract infection]. / Un caso di microangiopatia trombotica in corso di infezione urinaria.

An 84 year-old woman was admitted because of sepsis, thrombocytopenia, anaemia and acute renal failure that required hemodialysis. The diagnostic tests performed during hospitalization showed a severe urinary tract infection due to Enterococcus faecalis, resulting in mild sepsis. This infection was responsible for acute tubular necrosis and thrombotic microangiopathy, in a clinical context of difficult differential diagnosis and hemolytic-uremic syndrome.

Plasma erythropoietin concentrations in patients receiving intensive platinum or nonplatinum chemotherapy.

AIMS: Platinum chemotherapy has been shown to have potent antineoplastic activity against various tumours, especially testicular, bladder, ovarian, head and neck cancers. This activity is accompanied by side-effects of nephrotoxicity and cumulative myelosuppression, the latter frequently presenting as severe anaemia. Cisplatin and carboplatin nephrotoxicity might lower erythropoietin (Epo) secretion and, by this mechanism, contribute to the anaemia that follows therapy with this chemotherapeutic agent. The aim of the present work is to study the plasma immunoerythropoietin and haemoglobin levels of cancer patients treated with platinum or 5-fluorouracil-based chemotherapy. METHODS: Plasma was obtained from 25 patients who were about to receive chemotherapy for advanced malignancy: 15 treated with cisplatin or carboplatin and 10 with nonplatinum drugs. Blood was collected on the first day (before drug administration) and around day 15 of every chemotherapy course. Complete blood count, creatinine and immunoreactive Epo levels were also measured in 22 healthy volunteers. RESULTS: An increase in Epo levels occurred following every course of 5-FU or platinum based chemotherapy in patients with steady concentrations of creatinine and decreased levels of haemoglobin (Hb). In particular, we observed an increase after about 15 days of the chemotherapy treatment and the Epo levels declined toward normal just before the following course. This phenomenon was evident in every course. CONCLUSIONS: Our results suggest that chemotherapy administration, using the current standards of hydration and forced diuresis, slightly lowered Hb levels but did not depress Epo production, both in 5-FU and in platinum treated subjects.

Paclitaxel and carboplatin for recurrent salivary gland malignancies.

BACKGROUND: The use of chemotherapy for recurrent salivary gland carcinomas is under investigation. PATIENTS AND METHODS: Fourteen patients (10 males, 4 females; median age 55 years, range 20-70) with recurrent carcinomas of major (9 patients) and minor (5 patients) salivary gland origin (histology: 1 adenocarcinoma, 10 adenoid cystic carcinoma, 2 undifferentiated carcinoma, 1 mucoepidermoid carcinoma) were treated with carboplatin AUC 5.5 + paclitaxel 175 mg/m2 (3-hour infusion) on day 1 (interval = 3 weeks). All patients had been previously treated with surgery + radiotherapy and 8 with a cisplatin combination. One patient had a local lesion, 7 locoregional recurrence and metastases and 6 patients had metastases only. RESULTS: Overall 65 courses were given (median 5; range 2-6). Responses were: PR in 2 patients (14%) lasting 5 and 12 months; 7 NC (50%) with a median duration of 8.5 months (5-12); and 5 PD (36%). The median survival time was 13.5 months for PR/NC patients, 6 months for non responders; median overall survival was 12.5 months (3-17+). CONCLUSION: This combination had a moderate activity; the treatment was well tolerated and toxicity was manageable.

A randomized trial fo three cisplatin-containing regimens in advanced non-small-cell lung cancer (NSCLC): a study of the Umbrian Lung Cancer Group.

Survival in patients with locally advanced (stage III Mo) and metastatic (Ml) non-small-cell lung cancer (NSCLC) is short. Phase II studies have reported objective responses ranging from 20% to 60% using cisplatin-based chemotherapeutic regimens, yet few have shown improvement in median survival. In our phase II pilot studies with cisplatin (CDDP) and etoposide (VP-16), we observed a 26% response rate; with CDDP, VP-16, and mitomycin-C, a 38% response rate was obtained in advanced NSCLC patients. A total of 156 consecutive patients with locally advanced and metastatic NSCLC were randomized to one of three treatment arms to determine whether the chemotherapy protocols had any effect on response rate and median survival in a large, randomized study. Arm 1 consisted of CDDP (120 mg/m2 x 3 weeks); arm 2, of CDDP (120 mg/m2) and VP-16 (100 mg/m2 given i.v. on days 1-3), repeated every 3 weeks; and arm 3, of CDDP (120 mg/m2) and VP-16 (100 mg/m2 on days 1-3) given every 3 weeks, plus mitomycin C (10 mg/m2 on days 1, 21, and 42, then every 6 weeks, for a maximal dose of 100 mg). After 71 patients had been enrolled in the study, we stopped accrual in the CDDP arm due to a lack of response [1 complete response (CR) in 24 patients; 4%] and continued enrollment in the two combination-chemotherapy arms. In the CDDP/VP-16 arm a 30% response rate [1 CR, 18 partial responses (PRs)] was obtained, and in the CDDP/VP-16 mitomycin C arm a 26% response rate (4 CRs, 11 PRs) was seen among a total of 150 evaluable patients. Responses were observed in 31% of patients with favorable performance status (PS) (ECOG 0-1) vs 14% in patients with a poor PS (ECOG 2-3). Of patients with locally advanced disease (III Mo), 17 (33%) obtained an objective response, compared with 20 patients (20%) with metastatic disease. Median survival was 18 weeks in the CDDP arm, 35 weeks in the CDDP/VP-16 arm, and 37 weeks in the CDDP/VP-16/mitomycin C arm. The median survival in the multimodal chemotherapy arms was significantly greater than that obtained with CDDP alone. Toxicity was predominantly myelosuppression in the mitomycin C-containing arm (27%, wtto grade 3-4). Our study shows that combination chemotherapy using CDDP/VP-16 is active and safe in the treatment of advanced NSCLC patients with a good performance status. The addition of mitomycin C did not improve the therapeutic response.

Treatment of advanced non-small cell lung cancer (NSCLC): the "Umbria" cooperative study.

One hundred fifty-six patients with metastatic or locally advanced non-small cell lung cancer (NSCLC) were randomized to 3-week cycles of treatment with either: (A) cisplatin (120 mg/m2 on day 1); (B) cisplatin (120 mg/m2 on day 1) plus etoposide (VP-16) (100 mg/m2 on days 1-3; and (C) the cisplatin plus etoposide (VP-16) regimen plus mitomycin C (10 mg/m2 on days 1, 21, and 42; then every 6 weeks for a maximum dose of 100 mg). The overall objective response rates for the combination regimens (30% with two drugs and 26% with three drugs) were superior to that obtained with one drug (4%). Likewise, the median duration of survival with the combination therapy arms (8 to 9 months) was superior to that obtained with the single agent (5 months). Both performance status and limited disease were correlated with response in all groups, and with survival in the combined chemotherapy arms. The dose-limiting toxicity was myelosuppression, especially for the group receiving the three-drug regimen. In summary, combination chemotherapy using cisplatin and etoposide (VP-16) appears to be the most active and safest regimen in NSCLC.

Hodgkin's disease developing in a patient with angioimmunoblastic lymphadenopathy with dysproteinemia--a case report.

The case of a woman presenting the clinical and pathologic phenomena of angioimmunoblastic lymphadenopathy (AILD) with dysproteinemia is reported. The patient developed lesions in the lymph nodes, skin, lungs, liver and spleen, and her response to steroid and cyclophosphamide therapy was poor. At autopsy, microscopic findings in the mediastinal and abdominal lymph nodes were consistent with the diagnosis of Hodgkin's disease. Whereas the development of immunoblastic lymphoma is frequent in AILD, Hodgkin's disease is far less common. It is argued that malignant lymphoma in AILD may be the consequence of chronically depressed lymphocyte functions.

Acute effects of captopril in hypoxic pulmonary hypertension. Comparison with transient oxygen administration.

The present study was carried out to test the hypothesis of a possible effectiveness of captopril--an enzymatic inhibitor of both angiotensin II formation and bradykinin degradation--on hypoxic pulmonary hypertension. In 6 patients with this clinical condition, captopril-induced changes in pulmonary hemodynamics were observed after the acute administration of the drug with and without a short period of oxygen therapy at a flow rate sufficient to keep the PaO2 over 60 mm Hg. In our patients, captopril significantly lowered pulmonary arterial pressure and vascular resistance only when combined with oxygen, suggesting that an increase in bradykinin availability and/or a decrease in angiotensin II synthesis might be important factors in reversing pulmonary arterial hypertension only after blunting of the hypoxic stimulus on pulmonary circulation. Moreover, the authors suggest that the employment of vasodilators in the setting of hypoxic pulmonary hypertension should be considered not only as a means of relieving vasoconstriction but also as a possible tool for maintaining cardiac output and, in turn, peripheral oxygen delivery.

Severe glomerular mesangiolysis in a patient with rectal adenocarcinoma treated with cytotoxic drugs.

A 72 year old man with rectal adenocarcinoma developed chronic renal failure when treated by surgery and subsequent chemotherapy (5-fluorouracil, Mitomycin C and Cytosine arabinoside) and immunotherapy. Light microscopy provided evidence of severe glomerular changes with extensive mesangiolysis and vascular damage. Electron microscopy confirmed the mesangiolysis and showed nuclear changes in mesangial cells with nuclear pockets, chromatin loss and margination. There was further indirect evidence of endothelial cell damage. It is suggested that the glomerular changes should be attributed to a direct cytotoxic effect on the mesangial cells.