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Chest Mar 2019Tracheobronchial injury is a rare but a potentially high-impact event with significant morbidity and mortality. Common etiologies include blunt or penetrating trauma and... (Review)
Review
Tracheobronchial injury is a rare but a potentially high-impact event with significant morbidity and mortality. Common etiologies include blunt or penetrating trauma and iatrogenic injury that might occur during surgery, endotracheal intubation, or bronchoscopy. Early recognition of clinical signs and symptoms can help risk-stratify patients and guide management. In recent years, there has been a paradigm shift in the management of tracheal injury towards minimally invasive modalities, such as endobronchial stent placement. Although there are still some definitive indications for surgery, selected patients who meet traditional surgical criteria as well as those patients who were deemed to be poor surgical candidates can now be managed successfully using minimally invasive techniques. This paradigm shift from surgical to nonsurgical management is promising and should be considered prior to making final management decisions.
Topics: Bronchi; Conservative Treatment; Humans; Minimally Invasive Surgical Procedures; Patient Selection; Stents; Trachea; Wounds and Injuries
PubMed: 30059680
DOI: 10.1016/j.chest.2018.07.018 -
Respiratory Care May 2012We searched the MEDLINE, CINAHL, and Cochrane Library databases for articles published between January 1990 and December 2011. The update of this clinical practice...
We searched the MEDLINE, CINAHL, and Cochrane Library databases for articles published between January 1990 and December 2011. The update of this clinical practice guideline is based on 184 clinical trials and systematic reviews, and 10 articles investigating humidification during invasive and noninvasive mechanical ventilation. The following recommendations are made following the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) scoring system: 1. Humidification is recommended on every patient receiving invasive mechanical ventilation. 2. Active humidification is suggested for noninvasive mechanical ventilation, as it may improve adherence and comfort. 3. When providing active humidification to patients who are invasively ventilated, it is suggested that the device provide a humidity level between 33 mg H(2)O/L and 44 mg H(2)O/L and gas temperature between 34°C and 41°C at the circuit Y-piece, with a relative humidity of 100%. 4. When providing passive humidification to patients undergoing invasive mechanical ventilation, it is suggested that the HME provide a minimum of 30 mg H(2)O/L. 5. Passive humidification is not recommended for noninvasive mechanical ventilation. 6. When providing humidification to patients with low tidal volumes, such as when lung-protective ventilation strategies are used, HMEs are not recommended because they contribute additional dead space, which can increase the ventilation requirement and P(aCO(2)). 7. It is suggested that HMEs are not used as a prevention strategy for ventilator-associated pneumonia.
Topics: Critical Care; Humans; Humidity; Patient Selection; Respiration, Artificial; Respiratory Insufficiency; Steam; Tidal Volume
PubMed: 22546299
DOI: 10.4187/respcare.01766 -
Journal of Clinical Oncology : Official... Jun 2016To provide recommendations on appropriate clinical trial designs in non-muscle-invasive bladder cancer (NMIBC) based on current literature and expert consensus of the... (Review)
Review
PURPOSE
To provide recommendations on appropriate clinical trial designs in non-muscle-invasive bladder cancer (NMIBC) based on current literature and expert consensus of the International Bladder Cancer Group.
METHODS
We reviewed published trials, guidelines, meta-analyses, and reviews and provided recommendations on eligibility criteria, baseline evaluations, end points, study designs, comparators, clinically meaningful magnitude of effect, and sample size.
RESULTS
NMIBC trials must be designed to provide the most clinically relevant data for the specific risk category of interest (low, intermediate, or high). Specific eligibility criteria and baseline evaluations depend on the risk category being studied. For the population of patients for whom bacillus Calmette-Guérin (BCG) has failed, the type of failure (BCG unresponsive, refractory, relapsing, or intolerant) should be clearly defined to make comparisons across trials feasible. Single-arm designs may be relevant for the BCG-unresponsive population. Here, a clinically meaningful initial complete response rate (for carcinoma in situ) or recurrence-free rate (for papillary tumors) of at least 50% at 6 months, 30% at 12 months, and 25% at 18 months is recommended. For other risk levels, randomized superiority trial designs are recommended; noninferiority trials are to be used sparingly given the large sample size required. Placebo control is considered unethical for all intermediate- and high-risk strata; therefore, control arms should comprise the current guideline-recommended standard of care for the respective risk level. In general, trials should use time to recurrence or recurrence-free survival as the primary end point and time to progression, toxicity, disease-specific survival, and overall survival as potential secondary end points. Realistic efficacy thresholds should be set to ensure that novel therapies receive due review by regulatory bodies.
CONCLUSION
The International Bladder Cancer Group has developed formal recommendations regarding definitions, end points, and clinical trial designs for NMIBC to encourage uniformity among studies in this disease.
Topics: BCG Vaccine; Clinical Trials as Topic; Endpoint Determination; Humans; Neoplasm Recurrence, Local; Research Design; Sample Size; Urinary Bladder Neoplasms
PubMed: 26811532
DOI: 10.1200/JCO.2015.64.4070 -
Circulation Research Dec 2010coronary artery ligation to induce myocardial infarction (MI) in mice is typically performed by an invasive and time-consuming approach that requires ventilation and...
RATIONALE
coronary artery ligation to induce myocardial infarction (MI) in mice is typically performed by an invasive and time-consuming approach that requires ventilation and chest opening (classic method), often resulting in extensive tissue damage and high mortality. We developed a novel and rapid surgical method to induce MI that does not require ventilation.
OBJECTIVE
the purpose of this study was to develop and comprehensively describe this method and directly compare it to the classic method.
METHODS AND RESULTS
male C57/B6 mice were grouped into 4 groups: new method MI (MI-N) or sham (S-N) and classic method MI (MI-C) or sham (S-C). In the new method, heart was manually exposed without intubation through a small incision and MI was induced. In the classic method, MI was induced through a ventilated thoracotomy. Similar groups were used in an ischemia/reperfusion injury model. This novel MI procedure is rapid, with an average procedure time of 1.22 ± 0.05 minutes, whereas the classic method requires 23.2 ± 0.6 minutes per procedure. Surgical mortality was 3% in MI-N and 15.9% in MI-C. The rate of arrhythmia was significantly lower in MI-N. The postsurgical levels of tumor necrosis factor-α and myeloperoxidase were lower in new method, indicating less inflammation. Overall, 28-day post-MI survival rate was 68% with MI-N and 48% with MI-C. Importantly, there was no difference in infarct size or post-MI cardiac function between the methods.
CONCLUSIONS
this new rapid method of MI in mice represents a more efficient and less damaging model of myocardial ischemic injury compared with the classic method.
Topics: Animals; Coronary Vessels; Disease Models, Animal; Ligation; Male; Methods; Mice; Mice, Inbred C57BL; Myocardial Infarction; Research Design; Time Factors
PubMed: 20966393
DOI: 10.1161/CIRCRESAHA.110.223925 -
The Lancet. Respiratory Medicine Dec 2022Vilobelimab, an anti-C5a monoclonal antibody, was shown to be safe in a phase 2 trial of invasively mechanically ventilated patients with COVID-19. Here, we aimed to... (Randomized Controlled Trial)
Randomized Controlled Trial
Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.
BACKGROUND
Vilobelimab, an anti-C5a monoclonal antibody, was shown to be safe in a phase 2 trial of invasively mechanically ventilated patients with COVID-19. Here, we aimed to determine whether vilobelimab in addition to standard of care improves survival outcomes in this patient population.
METHODS
This randomised, double-blind, placebo-controlled, multicentre phase 3 trial was performed at 46 hospitals in the Netherlands, Germany, France, Belgium, Russia, Brazil, Peru, Mexico, and South Africa. Participants aged 18 years or older who were receiving invasive mechanical ventilation, but not more than 48 h after intubation at time of first infusion, had a PaO/FiO ratio of 60-200 mm Hg, and a confirmed SARS-CoV-2 infection with any variant in the past 14 days were eligible for this study. Eligible patients were randomly assigned (1:1) to receive standard of care and vilobelimab at a dose of 800 mg intravenously for a maximum of six doses (days 1, 2, 4, 8, 15, and 22) or standard of care and a matching placebo using permuted block randomisation. Treatment was not continued after hospital discharge. Participants, caregivers, and assessors were masked to group assignment. The primary outcome was defined as all-cause mortality at 28 days in the full analysis set (defined as all randomly assigned participants regardless of whether a patient started treatment, excluding patients randomly assigned in error) and measured using Kaplan-Meier analysis. Safety analyses included all patients who had received at least one infusion of either vilobelimab or placebo. This study is registered with ClinicalTrials.gov, NCT04333420.
FINDINGS
From Oct 1, 2020, to Oct 4, 2021, we included 368 patients in the ITT analysis (full analysis set; 177 in the vilobelimab group and 191 in the placebo group). One patient in the vilobelimab group was excluded from the primary analysis due to random assignment in error without treatment. At least one dose of study treatment was given to 364 (99%) patients (safety analysis set). 54 patients (31%) of 177 in the vilobelimab group and 77 patients (40%) of 191 in the placebo group died in the first 28 days. The all-cause mortality rate at 28 days was 32% (95% CI 25-39) in the vilobelimab group and 42% (35-49) in the placebo group (hazard ratio 0·73, 95% CI 0·50-1·06; p=0·094). In the predefined analysis without site-stratification, vilobelimab significantly reduced all-cause mortality at 28 days (HR 0·67, 95% CI 0·48-0·96; p=0·027). The most common TEAEs were acute kidney injury (35 [20%] of 175 in the vilobelimab group vs 40 [21%] of 189 in the placebo), pneumonia (38 [22%] vs 26 [14%]), and septic shock (24 [14%] vs 31 [16%]). Serious treatment-emergent adverse events were reported in 103 (59%) of 175 patients in the vilobelimab group versus 120 (63%) of 189 in the placebo group.
INTERPRETATION
In addition to standard of care, vilobelimab improves survival of invasive mechanically ventilated patients with COVID-19 and leads to a significant decrease in mortality. Vilobelimab could be considered as an additional therapy for patients in this setting and further research is needed on the role of vilobelimab and C5a in other acute respiratory distress syndrome-causing viral infections.
FUNDING
InflaRx and the German Federal Government.
Topics: Humans; COVID-19; SARS-CoV-2; Critical Illness; Respiration, Artificial; Treatment Outcome; Antibodies, Monoclonal; Double-Blind Method
PubMed: 36087611
DOI: 10.1016/S2213-2600(22)00297-1 -
Acta Bio-medica : Atenei Parmensis Jan 2019Breast cancer is the most common noncutaneous malignancy among women worldwide. After a breast cancer removal procedure, women are asked to decide about breast... (Review)
Review
BACKGROUND
Breast cancer is the most common noncutaneous malignancy among women worldwide. After a breast cancer removal procedure, women are asked to decide about breast reconstruction, mainly to improve their life quality, and they can choose from among many options. Broadly, there are two different types of breast reconstruction procedures: prosthetic implant-based reconstruction and autologous tissue-based reconstruction.
METHODS
Implant-breast reconstruction is a minimally invasive procedure compared with autologous breast reconstruction. It is associated with fewer short- and long-term complications.
RESULTS
The ideal candidates for implant-based reconstruction are patients with non-redundant soft tissue coverage, who desire a moderate sized non-ptotic breast and have not been previously irradiated.
CONCLUSION
The state of the art for implant-breast reconstruction is briefly described in this article.
Topics: Breast Implantation; Breast Implants; Breast Neoplasms; Female; Humans; Patient Selection
PubMed: 30657111
DOI: 10.23750/abm.v89i4.5748 -
HPB : the Official Journal of the... Mar 2017The first International conference on Minimally Invasive Pancreas Resection was arranged in conjunction with the annual meeting of the International... (Review)
Review
BACKGROUND
The first International conference on Minimally Invasive Pancreas Resection was arranged in conjunction with the annual meeting of the International Hepato-Pancreato-Biliary Association (IHPBA), in Sao Paulo, Brazil on April 19th 2016. The presented evidence and outcomes resulting from the session for minimally invasive distal pancreatectomy (MIDP) is summarized and addressed perioperative outcome, the outcome for cancer and patient selection for the procedure.
METHODS
A literature search was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to compare MIDP and open distal pancreatectomy. Patient selection was discussed based on plenary talks, panel discussions and a worldwide survey on MIDP.
RESULTS
Of 582 studies, 52 (40 observational and 12 case-matched) were included in the assessment for outcome for LDP (n = 5023) vs. ODP (n = 16,306) whereas 16 observational comparative studies were identified for cancer outcome. No randomized trials were identified. MIDP resulted in similar outcome to ODP with a tendency for lower blood loss and shorter hospital stay in the MIDP group.
DISCUSSION
Available evidence for comparison of MIDP to ODP is weak, although the number of studies is high. Observed outcomes of MIDP are promising. In the absence of randomized control trials, an international registry should be established.
Topics: Congresses as Topic; Evidence-Based Medicine; Humans; Laparoscopy; Pancreatectomy; Patient Selection; Postoperative Complications; Risk Factors; Robotic Surgical Procedures; Treatment Outcome
PubMed: 28215903
DOI: 10.1016/j.hpb.2017.01.009 -
Annals of Thoracic and Cardiovascular... 2013Thoracotomic esophagectomy followed by cervical and abdominal procedures has been conventionally performed as the best curable operative procedure for treating invasive... (Review)
Review
Thoracotomic esophagectomy followed by cervical and abdominal procedures has been conventionally performed as the best curable operative procedure for treating invasive thoracic esophageal carcinoma. Despite improvements in the survival rate, the procedure is associated with significant operative morbidity and mortality rates due to the extreme invasiveness of an extensive dissection of the lymph nodes. Minimally invasive esophagectomy (MIE) was developed to reduce surgical invasiveness. Recently, the use of thoracoscopic esophagectomy performed in the prone position has stimulated new interest in minimally invasive approaches. However, the advantages and disadvantages of this technique are not well known. In this review, the literature to date, including series and comparative studies of minimally invasive esophagectomy performed in the prone position, is summarized, and the various lessons learned and controversies surrounding this technique are addressed.
Topics: Carcinoma; Esophageal Neoplasms; Esophagectomy; Humans; Lymph Node Excision; Patient Positioning; Postoperative Complications; Prone Position; Thoracoscopy; Treatment Outcome
PubMed: 24284506
DOI: 10.5761/atcs.ra.13-00262 -
Cleveland Clinic Journal of Medicine Jun 2019Colorectal cancer, the second most common type of cancer and cause of cancer-related deaths in the United States, can largely be prevented by screening. The 2 most used... (Review)
Review
Colorectal cancer, the second most common type of cancer and cause of cancer-related deaths in the United States, can largely be prevented by screening. The 2 most used methods in the United States are colonoscopy and fecal immunochemical testing (FIT). FIT is noninvasive but must be done yearly for optimal performance and, if positive, must be followed by colonoscopy. Colonoscopy is invasive, operator-dependent, and more expensive, but it can detect and remove polyps during the same procedure. The choice of test depends on patient preference, family history, and the likelihood of compliance.
Topics: Aged; Colonoscopy; Colorectal Neoplasms; Early Detection of Cancer; Female; Humans; Male; Middle Aged; Occult Blood; Patient Preference; Patient Selection; United States
PubMed: 31204977
DOI: 10.3949/ccjm.86a.17125 -
TheScientificWorldJournal 2020Bowel preparation traditionally refers to the removal of bowel contents via mechanical cleansing measures. Although it has been a common practice for more than 70 years,... (Meta-Analysis)
Meta-Analysis Review
Bowel preparation traditionally refers to the removal of bowel contents via mechanical cleansing measures. Although it has been a common practice for more than 70 years, its use is based mostly on expert opinion rather than solid evidence. Mechanical bowel preparation in minimally invasive and vaginal gynecologic surgery is strongly debated, since many studies have not confirmed its effectiveness, neither in reducing postoperative infectious morbidity nor in improving surgeons' performance. A comprehensive search of Medline/PubMed and the Cochrane Library Database was conducted, for related articles up to June 2019, including terms such as "mechanical bowel preparation," "vaginal surgery," "minimally invasive," and "gynecology." We aimed to determine the best practice regarding bowel preparation before these surgical approaches. In previous studies, bowel preparation was evaluated only via mechanical measures. The identified randomized trials in laparoscopic approach and in vaginal surgery were 8 and 4, respectively. Most of them compare different types of preparation, with patients being separated into groups of oral laxatives, rectal measures (enema), low residue diet, and fasting. The outcomes of interest are the quality of the surgical field, postoperative infectious complications, length of hospital stay, and patients' comfort during the whole procedure. The results are almost identical regardless of the procedure's type. Routine administration of bowel preparation seems to offer no advantage to any of the objectives mentioned above. Taking into consideration the fact that in most gynecologic cases there is minimal probability of bowel intraluminal entry and, thus, low surgical site infection rates, most scientific societies have issued guidelines against the use of any bowel preparation regimen before laparoscopic or vaginal surgery. Nonetheless, surgeons still do not use a specific pattern and continue ordering them. However, according to recent evidence, preoperative bowel preparation of any type should be omitted prior to minimally invasive and vaginal gynecologic surgeries.
Topics: Female; Gynecologic Surgical Procedures; Humans; Minimally Invasive Surgical Procedures; Patient Outcome Assessment; Preoperative Care; Vagina
PubMed: 32110164
DOI: 10.1155/2020/8546037