Anestesia en enfermedades raras.

Information about the website Orphananesthesia (www.orphananesthesia.eu), a database on the anesthetic management of patients with rare diseases is presented. Emphasis is focused on patient safety, as well as up-to-date and comprehensive, peer reviewed, and easy-to-access information. In a few weeks, the website will be available in Spanish, in addition to English.Se presenta información acerca de la web Orphananesthesia (www.orphananesthesia.eu), una base de datos del tratamiento anestésico de pacientes con enfermedades raras. Se hace énfasis en los aspectos que conlleva de seguridad para los pacientes y de información actualizada y compendiada, así como revisada por expertos, de fácil accesibilidad. La web estará disponible en breve en español, además de en inglés.  

Association between time to reperfusion and outcome is primarily driven by the time from imaging to reperfusion

Background and Purpose A progressive decline in the odds of favorable outcome as time to reperfusion increases is well known. However, the impact of specific workflow intervals is not clear.; Methods We studied the mechanical thrombectomy group (n=103) of the prospective, randomized REVASCAT (Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke due to Anterior Circulation Large Vessel Occlusion Presenting Within Eight Hours of Symptom Onset) trial. We defined 3 workflow metrics: time from symptom onset to reperfusion (OTR), time from symptom onset to computed tomography, and time from computed tomography (CT) to reperfusion. Clinical characteristics, core laboratory-evaluated Alberta Stroke Program Early CT Scores (ASPECTS) and 90-day outcome data were analyzed. The effect of time on favorable outcome (modified Rankin scale, 0-2) was described via adjusted odds ratios (ORs) for every 30-minute delay.; Results Median admission National Institutes of Health Stroke Scale was 17.0 (14.0-20.0), reperfusion rate was 66%, and rate of favorable outcome was 43.7%. Mean (SD) workflow times were as follows: OTR: 342 (107) minute, onset to CT: 204 (93) minute, and CT to reperfusion: 138 (56) minute. Longer OTR time was associated with a reduced likelihood of good outcome (OR for 30-minute delay, 0.74; 95% confidence interval [CI], 0.59-0.93). The onset to CT time did not show a significant association with clinical outcome (OR, 0.87; 95% CI, 0.67-1.12), whereas the CT to reperfusion interval showed a negative association with favorable outcome (OR, 0.72; 95% CI, 0.54-0.95). A similar subgroup analysis according to admission ASPECTS showed this relationship for OTR time in ASPECTS<8 patients (OR, 0.56; 95% CI, 0.35-0.9) but not in ASPECTS8 (OR, 0.99; 95% CI, 0.68-1.44).; Conclusions Time to reperfusion is negatively associated with favorable outcome, being CT to reperfusion, as opposed to onset to CT, the main determinant of this association. In addition, OTR was strongly associated to outcome in patients with low ASPECTS scores but not in patients with high ASPECTS scores.; Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT01692379.Peer ReviewedPostprint (author's final draft

Transfer to the Local Stroke Center vs Direct Transfer to Endovascular Center of Acute Stroke Patients with Suspected Large Vessel Occlusion in the Catalan Territory (RACECAT): study protocol of a cluster randomized within a cohort trial

Rationale: Optimal pre-hospital delivery pathways for acute stroke patients suspected to harbor a large vessel occlusion (LVO) have not been assessed in randomized trials. Aim: To establish whether stroke subjects with RACE scale based suspicion of LVO evaluated by Emergency Medical Services in the field, have higher rates of favorable outcome when transferred directly to an Endovascular Center (EVT-SC), as compared to the standard transfer to the closest Local Stroke Center (Local-SC).Design: Multicenter, superiority, cluster randomized within a cohort trial with blinded endpoint assessment. Procedure: Eligible patients must be 18 or older, have acute stroke symptoms and not have an immediate life threatening condition requiring emergent medical intervention. They must be suspected to have intracranial LVO based on a pre-hospital RACE scale of ≥5, be located in geographical areas where the default health authority assigned referral stroke center is a non-thrombectomy capable hospital, and estimated arrival at a thrombectomy capable stroke hospital in less than 7 hours from time last seen well. Cluster randomization is performed according to a pre-established temporal sequence (temporal cluster design) with 3 strata: day/night, distance to the EVT-SC and week/week-end day. Study outcome: The primary endpoint is the modified Rankin Scale (mRS) score at 90 days. The primary safety outcome is mortality at 90 days. Analysis: The primary endpoint based on the modified intention-to-treat population is the distribution of modified Rankin Scale scores (mRS) at 90 days analyzed under a sequential triangular design. The maximum sample size is 1754 patients, with two planned interim analyses when 701 (40%) and 1227 patients have completed follow-up. Hypothesized common odds ratio is 1.35.The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The trial is sponsored by the nonprofit foundation Fundació Privada Ictus Malaltia Vascular, beneficiary of an unrestricted grant by Medtronic. Trial sponsor: Fundació Privada Ictus Malaltia Vascular. Elisabeth Ortínez ([email protected]). Study sponsor and funders do not participate in the study design, collection, management, analysis and interpretation of data, writing of the report or the decision to submit results for publication

Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study

BackgroundThe use of remote consultation modalities has exponentially grown in the past few years, particularly since the onset of the COVID-19 pandemic. Although a huge body of the literature has described the use of phone (tele) and video consultations, very few of the studies correspond to randomized controlled trials, and none of them has assessed the safety of these consultation modalities as the primary objective. The primary objective of this trial was to assess the safety of remote consultations (both video and teleconsultation) in the follow-up of patients in the hospital setting.MethodsMulticenter, randomized controlled trial being conducted in four centers of an administrative healthcare area in Catalonia (North-East Spain). Participants will be screened from all individuals, irrespective of age and sex, who require follow-up in outpatient consultations of any of the departments involved in the study. Eligibility criteria have been established based on the local guidelines for screening patients for remote consultation. Participants will be randomly allocated into one of the two study arms: conventional face-to-face consultation (control) and remote consultation, either teleconsultation or video consultation (intervention). Routine follow-up visits will be scheduled at a frequency determined by the physician based on the diagnostic and therapy of the baseline disease (the one triggering enrollment). The primary outcome will be the number of adverse reactions and complications related to the baseline disease. Secondary outcomes will include non-scheduled visits and hospitalizations, as well as usability features of remote consultations. All data will either be recorded in an electronic clinical report form or retrieved from local electronic health records. Based on the complications and adverse reaction rates reported in the literature, we established a target sample size of 1068 participants per arm. Recruitment started in May 2022 and is expected to end in May 2024.DiscussionThe scarcity of precedents on the assessment of remote consultation modalities using randomized controlled designs challenges making design decisions, including recruitment, selection criteria, and outcome definition, which are discussed in the manuscript.Trial registrationNCT05094180. The items of the WHO checklist for trial registration are available in Additional file 1. Registered on 24 November 2021

Analysis of the ‘Evaluation Indicators’ of an Enhanced Recovery After Bariatric Surgery Pathway in the First Six Months After Implementation

The implementation of a clinical pathway in bariatric surgery (BS) might facilitate systemic care. Focusing on enhanced recovery after surgery (ERAS) programs may also improve surgical outcomes depending on the degree of adherence achieved. We hypothesized that the implementation of an ERAS clinical pathway in BS (ERABS) improves clinical outcomes compared to traditional treatment in a tertiary care hospital. The main objective was to assess the degree of adherence to the ERABS program. Secondary objectives were to evaluate compliance with the quality indicators of the Spanish Society for Obesity Surgery (SECO) and overall patients’ satisfaction. A retrospective observational study was designed. Data from patients who underwent BS into an ERABS context were reviewed and compared with traditionally treated patients. Process and outcomes indicators adapted from RICA (Recuperación Intensificada en Cirugía Abdominal) pathway, degree of compliance with SECO quality indicators and patients’ satisfaction were analyzed. Forty-three patients were included per group. Indicators' compliance rate per patient was 83.23%. Differences were found in postoperative bleeding, immediate morbidity and overall morbidity, but not in severity of complications. No patient felt dissatisfied or unsatisfied. Average compliance with indicators of process and outcome was 90.45%. Overall morbidity in ERABS group did not differ from that recommended by SECO, but traditional group did show significant increase. Adherence was 83.63% and overall incidence of complications was 7%. Our study shows improved clinical outcomes in ERABS group with a high degree of adherence. Quality indicators were met, improving overall morbidity with no difference in the severity of complications

REVASCAT: a randomized trial of revascularization with SOLITAIRE FR® device vs. best medical therapy in the treatment of acute stroke due to anterior circulation large vessel occlusion presenting within eight-hours of symptom onset

REVASCAT is a prospective, multicenter, randomized trial seeking to establish whether subjects meeting following main inclusion criteria: age 18-80, baseline National Institutes of Health Stroke Scale = 6, evidence of intracranial internal carotid artery or proximal (M1 segment) middle cerebral artery occlu- sion, Alberta Stroke Program Early Computed Tomography score of > 7 on non-contrast CT or > 6 on diffusion-weighted magnetic resonance imaging , ineligible for or with persistent occlusion after intravenous alteplase and procedure start within 8 hours from symptom onset, have higher rates of favorable outcome when treated with the SolitaireTM FR embolectomy device compared to standard medical therapy alone The primary end-point, based on intention-to-treat cri- teria is the distribution of modified Rankin Scale scores at 90 days. Projected sample size is 690 patients. Estimated common odds ratio is 1•615. Randomization is performed under a mini- mization process using age, baseline NIHSS, therapeutic window, occlusion location and investigational center. The study follows a sequential analysis (triangular model) with the first approach to test efficacy at 174 patients and subsequent analyses (if necessary) at 346, 518, and 690 subjects. Secondary end-points are infarct volume evaluated on CT at 24 h, dra- matic early favorable response, defined as NIHSS of 0–2 or NIHSS improvement = 8 points at 24 h and successful recanali- zation in the Solitaire arm according to the thrombolysis in cerebral infarction (TICI) classification defined as TICI 2b or 3. Safety variables are mortality at 90 days, symptomatic intrac- ranial haemorrhage rates at 24 hours and procedure related complications.Peer Reviewe

Association between time to reperfusion and outcome is primarily driven by the time from imaging to reperfusion

Background and Purpose A progressive decline in the odds of favorable outcome as time to reperfusion increases is well known. However, the impact of specific workflow intervals is not clear.; Methods We studied the mechanical thrombectomy group (n=103) of the prospective, randomized REVASCAT (Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke due to Anterior Circulation Large Vessel Occlusion Presenting Within Eight Hours of Symptom Onset) trial. We defined 3 workflow metrics: time from symptom onset to reperfusion (OTR), time from symptom onset to computed tomography, and time from computed tomography (CT) to reperfusion. Clinical characteristics, core laboratory-evaluated Alberta Stroke Program Early CT Scores (ASPECTS) and 90-day outcome data were analyzed. The effect of time on favorable outcome (modified Rankin scale, 0-2) was described via adjusted odds ratios (ORs) for every 30-minute delay.; Results Median admission National Institutes of Health Stroke Scale was 17.0 (14.0-20.0), reperfusion rate was 66%, and rate of favorable outcome was 43.7%. Mean (SD) workflow times were as follows: OTR: 342 (107) minute, onset to CT: 204 (93) minute, and CT to reperfusion: 138 (56) minute. Longer OTR time was associated with a reduced likelihood of good outcome (OR for 30-minute delay, 0.74; 95% confidence interval [CI], 0.59-0.93). The onset to CT time did not show a significant association with clinical outcome (OR, 0.87; 95% CI, 0.67-1.12), whereas the CT to reperfusion interval showed a negative association with favorable outcome (OR, 0.72; 95% CI, 0.54-0.95). A similar subgroup analysis according to admission ASPECTS showed this relationship for OTR time in ASPECTS<8 patients (OR, 0.56; 95% CI, 0.35-0.9) but not in ASPECTS8 (OR, 0.99; 95% CI, 0.68-1.44).; Conclusions Time to reperfusion is negatively associated with favorable outcome, being CT to reperfusion, as opposed to onset to CT, the main determinant of this association. In addition, OTR was strongly associated to outcome in patients with low ASPECTS scores but not in patients with high ASPECTS scores.; Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT01692379.Peer Reviewe

REVASCAT: a randomized trial of revascularization with SOLITAIRE FR® device vs. best medical therapy in the treatment of acute stroke due to anterior circulation large vessel occlusion presenting within eight-hours of symptom onset

REVASCAT is a prospective, multicenter, randomized trial seeking to establish whether subjects meeting following main inclusion criteria: age 18-80, baseline National Institutes of Health Stroke Scale = 6, evidence of intracranial internal carotid artery or proximal (M1 segment) middle cerebral artery occlu- sion, Alberta Stroke Program Early Computed Tomography score of > 7 on non-contrast CT or > 6 on diffusion-weighted magnetic resonance imaging , ineligible for or with persistent occlusion after intravenous alteplase and procedure start within 8 hours from symptom onset, have higher rates of favorable outcome when treated with the SolitaireTM FR embolectomy device compared to standard medical therapy alone The primary end-point, based on intention-to-treat cri- teria is the distribution of modified Rankin Scale scores at 90 days. Projected sample size is 690 patients. Estimated common odds ratio is 1•615. Randomization is performed under a mini- mization process using age, baseline NIHSS, therapeutic window, occlusion location and investigational center. The study follows a sequential analysis (triangular model) with the first approach to test efficacy at 174 patients and subsequent analyses (if necessary) at 346, 518, and 690 subjects. Secondary end-points are infarct volume evaluated on CT at 24 h, dra- matic early favorable response, defined as NIHSS of 0–2 or NIHSS improvement = 8 points at 24 h and successful recanali- zation in the Solitaire arm according to the thrombolysis in cerebral infarction (TICI) classification defined as TICI 2b or 3. Safety variables are mortality at 90 days, symptomatic intrac- ranial haemorrhage rates at 24 hours and procedure related complications.Peer Reviewe

A multifaceted individualized pneumoperitoneum strategy for laparoscopic colorectal surgery: a multicenter observational feasibility study

Background: While guidelines for laparoscopic abdominal surgery advise using the lowest possible intra-abdominal pressure, commonly a standard pressure is used. We evaluated the feasibility of a predefined multifaceted individualized pneumoperitoneum strategy aiming at the lowest possible intra-abdominal pressure during laparoscopic colorectal surgery. Methods: Multicenter prospective study in patients scheduled for laparoscopic colorectal surgery. The strategy consisted of ventilation with low tidal volume, a modified lithotomy position, deep neuromuscular blockade, pre-stretching of the abdominal wall, and individualized intra-abdominal pressure titration; the effect was blindly evaluated by the surgeon. The primary endpoint was the proportion of surgical procedures completed at each individualized intra-abdominal pressure level. Secondary endpoints were the respiratory system driving pressure, and the estimated volume of insufflated CO2 gas needed to perform the surgical procedure. Results: Ninety-two patients were enrolled in the study. Fourteen cases were converted to open surgery for reasons not related to the strategy. The intervention was feasible in all patients and well-accepted by all surgeons. In 61 out of 78 patients (78%), surgery was performed and completed at the lowest possible IAP, 8 mmHg. In 17 patients, IAP was raised up to 12 mmHg. The relationship between IAP and driving pressure was almost linear. The mean estimated intra-abdominal CO2 volume at which surgery was performed was 3.2 L. Conclusion: A multifaceted individualized pneumoperitoneum strategy during laparoscopic colorectal surgery was feasible and resulted in an adequate working space in most patients at lower intra-abdominal pressure and lower respiratory driving pressure. ClinicalTrials.gov (Trial Identifier: NCT03000465)

Ionic aspects of the physiology and biology of Macrobrachium rosenbergii (De Man) 1879

SIGLEAvailable from British Library Document Supply Centre- DSC:D171490 / BLDSC - British Library Document Supply CentreGBUnited Kingdo