Effectiveness of Early Tracheostomy compared with Late Tracheostomy Or Prolonged Orotracheal Intubation in Traumatic Brain Injury: Protocol of Systematic Review

Review question / Objective: What is the effectiveness of Early Tracheostomy compared with Late Tracheostomy Or Prolonged Orotracheal Intubation in Traumatic Brain Injury? Condition being studied: Traumatic Brain Injury (TBI) is every traumatic anatomical ou functional injury that affects brain, skull and/or vessels related to them. TBI is a public health problem that involves over 50 million people per year in Worldwide. Information sources: PUBLISHED DATABASES (Medline by PUBMED, Lilacs, Central-Cochrane, Scopus by Elsevier, Web Of Science e Embase by Elsevier) NON-PUBLISHED (Open Grey by Sigle; Clinical Trial Register at the International Clinical Trials Registry Platform) (Referencies of the selected studies).

Comparison of Double-Lumen Tube and EZ-Blocker for Lung Separation in Thoracic Surgery - A Randomised Controlled Clinical Trial

Background:Double lumen tube (DLT) intubation is the most commonly used technique for lung separation. Bronchial blockers (BB) are an alternative, especially for difficult airways. The EZ-bronchial blocker (EZB) is the newest device of the BB family. Methods:A randomised, controlled trial was conducted in 80 patients undergoing elective thoracic surgery using DLT or SLT plus EZB for lung separation (German Clinical Trial Register DRKS00014816). The objective of the study was to compare the clinical performance of EZB with DLT. Primary endpoint was total time to successful lung separation. Secondary endpoints were time subsections, quality of lung collapse, difficulty of intubation, any complications during the procedure, incidence of objective trauma of the oropharynx and supraglottic space and intubation-related subjective symptoms.Results:74 patients were included, DLT group (n = 38), EZB group (n = 36). Median total time for lung separation [IQR] in DLT group was 234 seconds [207 to 294] versus 298 seconds [243 to 369] in EZB group (P=0.007). Quality of lung collapse was equal in both groups, DLT group 89.5% were excellent vs. 83.3 % in the EZB group (P=0.444). Inadequate lung collapse in five patients of the EZB group resulted in unsuccessful repositioning attempts and secondary DLT placement. Endoscopic examinations revealed significantly more carina trauma (P=0.047) and subglottic haemorrhage (P=0.047) in the DLT group. Additionally, postoperative subjective symptoms (sore throat, hoarseness) were more common in the DLT group, as were speech problems.Conclusions:Using the EZB results in prolonged lung separation compared to DLT, prima facie with equal quality of lung collapse for the thoracic surgeon. Five crossover cases demonstrated the superiority of the use of left-sided DLT especially in the indication for EZB for a right open thoracotomy or right video-assisted thoracoscopic surgery (VATS). Using the EZB showed only little evidence for reducing objective airway trauma e.g. less carina trauma as well as subjective complaints.Trial registration:German Clinical Trial Register DRKS00014816, prospectively registered on 07.06.2018https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014816

Trends and Variation in Data Quality on the EU Clinical Trials Register: A Cross-Sectional Study

The EU Clinical Trial Register (EUCTR) is a public facing portal containing information on trials of medicinal products conducted in the European Union (EU) and European Economic Area (EEA). Today, the registry holds information on over 30,000 trials. Given its distinct regulatory purpose, and results reporting requirements, the EUCTR should be a valuable open-source hub for trial information. Past work examining the EUCTR has suggested that data quality on the registry may be lacking. Using the full EUCTR public dataset, we examined areas in which national regulators are expected to ensure data quality including the posting of registrations, updating trial completion information, and monitoring results posting in line with EU guidelines. We identified issues across all areas examined with notable research hubs like France, Spain, and The Netherlands lacking consistent and complete data on the registry. These deficiencies complicate the utility of the EUCTR for research, transparency, and accountability efforts.

Long-term outcomes after endoscopic retrograde pancreatic drainage for symptomatic pancreaticojejunal anastomotic stenosis

There is limited evidence supporting the usefulness of endoscopic retrograde pancreatic drainage (ERPD) for symptomatic pancreaticojejunal anastomotic stenosis (sPJS). We examined the usefulness of ERPD for sPJS. We conducted a retrospective analysis of 10 benign sPJS patients. A forward-viewing endoscope was used in all sessions. Following items were evaluated: technical success, adverse events, and clinical outcome of ERPD. The technical success rate was 100% (10/10) in initial ERPD; 9 patients had a pancreatic stent (no-internal-flap: n = 4, internal-flap: n = 5). The median follow-up was 920 days. Four patients developed recurrence. Among them, 3 had a stent with no-internal-flap in initial ERPD, the stent migrated in 3 at recurrence, and a stent was not placed in 1 patient in initial ERPD. Four follow-up interventions were performed. No recurrence was observed in 6 patients. None of the stents migrated (no-internal-flap: n = 1, internal-flap: n = 5) and no stents were replaced due to stent failure. Stenting with no-internal-flap was associated with recurrence (p = 0.042). Mild adverse events developed in 14.3% (2/14). In conclusions, ERPD was performed safely with high technical success. Recurrence was common after stenting with no-internal-flap. Long-term stenting did not result in stent failure.Clinical trial register and their clinical registration number: Nos. 58-115 and R2-9.

Overall reduced lymphocyte especially T and B subsets closely related to the poor prognosis and the disease severity in severe patients with COVID-19 and diabetes mellitus

Background A dysregulated host immune response is common in patients with COVID-19. Aim In this study, we aimed to define the characteristics of lymphocyte subsets and their relationship with disease progression in COVID-19 patients with or without diabetes mellitus (DM). Methods The baseline peripheral lymphocyte subsets were compared between 55 healthy controls and 95 patients with confirmed COVID-19, and between severe and non-severe COVID-19 patients with or without DM. Results The prevalence of DM in the COVID-19 group was 20%, and patients with severe COVID-19 had a higher prevalence of DM than those with non-severe disease (P = 0.006). Moreover, a significantly poor prognosis and a higher rate of severity were found in those with DM relative to those without DM (P = 0.001, 0.003). Generally, all lymphocytes and subsets of lymphocytes, especially B and T cells, were significant reduced in COVID-19 patients, particularly in those with DM. Patients with severe COVID-19 and DM had the lowest lymphocyte counts compared with those with severe COVID-19 without DM, and those with non-severe COVID-19 with or without DM. Partially decreased lymphocyte subsets, age and DM were closely related to disease progression and prognosis. Conclusions These findings provide a reference for clinicians that immunomodulatory treatment may improve disease progression and prognosis of COVID-19 patients, especially those with severe disease with DM. Trial registration Chinese Clinical Trial Register ChiCTR2000034563

Doxapram alleviates low SpO2 induced by the combination of propofol and fentanyl during painless gastrointestinal endoscopy

Background Painless gastrointestinal endoscopy under intravenous propofol anesthesia is widely applied in the clinical scenario. Despite the good sedation and elimination of anxiety that propofol provides, low SpO2 may also result. Doxapram is a respiratory stimulant with a short half-life. The primary aim of this study was to investigate the effects of doxapram on alleviating low SpO2 induced by the combination of propofol and fentanyl during painless gastrointestinal endoscopy. Methods In this prospective study, patients scheduled for painless gastrointestinal endoscopy were randomly assigned to group D or S with 55 patients per group. Initially, both groups received a combination of propofol and fentanyl. Patients in group D received 50 mg doxapram after propofol injection, while patients in group S received an equal volume of saline. Vital signs of the patients, propofol dose, examination duration, and incidences of low SpO2 were recorded. Results There were no statistical differences in propofol consumption and examination duration between the two groups. Twenty-six patients in group S experienced low SpO2 versus 10 in group D (P = 0.001). Nineteen patients in group S underwent oxygenation with a face mask in contrast to 8 in group D (P = 0.015). Eighteen patients in group S were treated with jaw lifting compared to 5 in group D (P = 0.002). Four patients in group S underwent assisted respiration compared to 2 in group D (without statistical difference). The average oxygen saturation in group S was significantly lower than that in group D at 1, 2 and 3 min after propofol injection (P < 0.001, P = 0.001 and P = 0.020, respectively). There were no statistical differences in oxygen saturation at other time points. There were no statistical differences in MAP and HR (except for the time point of 1 min after the induction) between the two groups. Conclusions Low dose of doxapram can effectively alleviate low SpO2 in painless gastrointestinal endoscopy with intravenous propofol, without affecting propofol consumption, examination duration, MAP, or HR. Trail registration The study was approved by the Institutional Ethics Committee of Clinical and New Technology of Wuxi People’s Hospital on 20th July, 2018 (KYLLH2018029) and registered in the Chinese Clinical Trial Register on 16th August, 2018 (ChiCTR1800017832).

Night sleep duration and sleep initiation time with hypertension in Chinese rural population: the Henan Rural Cohort

Background The study was conducted to evaluate the independent dose-response of the night sleep duration and sleep initiation time on hypertension, and to explore their combined effect with hypertension. Methods Participants from the Henan Rural Cohort were enrolled in this study. Information on sleep was collected using the Pittsburgh Sleep Quality Index. Hypertension was defined as systolic blood pressure/diastolic blood pressure ≥140/90 mmHg or self-reported hypertension and current use of anti-hypertensive medicines. Logistic regression and restricted cubic spline were conducted to evaluate the association of night sleep duration and sleep initiation time with hypertension. Results Of the 37 317 included participants, 12 333 suffered from hypertension. 14 474 (38.79%) were men and 22 843 (61.21%) were women, the mean age were 57.18 ± 12.10 and 55.24 ± 11.98 in men and women. Compared to reference (7–h), fully adjusted odd ratios (ORs) and 95% confidence interval (CI) of hypertension were 0.91 (0.66–1.25) in <5 h group and 1.74 (1.41–2.16) in ≥10 h among men, respectively. Fully adjusted ORs (95% CIs) for hypertension compared with reference (21:00–22:00) were 1.05 (95% CI 0.78–1.41) in the <20:00 group, 1.52 (1.25–1.85) in ≥24:00 in men. The combined effect of sleep duration and sleep initiation time on hypertension were statistically significant in the category of (≥8 h)/night and ≥24:00 (OR 1.87, 95% CI 1.07–3.25) compared to reference in fully adjusted model among men. Conclusions Long night sleep duration and late sleep initiation time were associated with the higher odds of hypertension, and the sleep duration and sleep initiation time might cumulatively increase the prevalence of hypertension in men. Clinical trial registration The Henan Rural Cohort Study has been registered at the Chinese Clinical Trial Register (Registration number: ChiCTR-OOC-15006699). http://www.chictr.org.cn/showproj.aspx? proj=11375.

Twins as Participants in Randomized Controlled Trials: A Review of Published Literature

Monozygotic (MZ) and dizygotic (DZ) twins participate in research that partitions variance in health, disease, and behavior into genetic and environmental components. However, there are other innovative roles for twins in medical research. One such way is involving MZ and/or DZ twins in co-twin control-designed randomized controlled trials (RCTs). To our knowledge, no reviews have been conducted that summarizes the involvement of twins in RCTs. Therefore, we conducted a systematic literature search using the U.S. Clinical Trials Database, NHS electronic databases, MEDLINE, EMBASE, and PsychINFO for RCTs on publications involving MZ and/or DZ twins as RCT participants. Out of the 186,027 clinical trials registered in the U.S. clinical trial register ClinicaTrails.gov, only six RCTs used twins as participants. From 1,598 articles identified in our search, 50 peer-reviewed English language publications met our pre-defined inclusion criteria. Sample sizes for RCTs have ranged from a total number of participants from 2 to 1,162; however, 32 (64%) studies had a sample size of 100 or less, and of those, 12 (24%) had fewer than 10. Both MZ and DZ twins have been recruited to the RCTs. In most instances (33/50) each twin from a pair were assigned to different study arms. Most of those studies included MZ twins only. Despite the methodological advantages, the use of MZ and DZ twins as participants in interventional RCTs appeared limited. The continuous development of innovative twin designs, especially RCTs, indicates that twin research can extend beyond the more widely recognized heritability estimates.