In search of “Clinical Trial Register — Version 2.0”

Abstract 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

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More on compulsory registration of clinical trials: Complete clinical trial register is already reality for paediatrics

BMJ ◽

10.1136/bmj.330.7489.480 ◽

2005 ◽

Vol 330 (7489) ◽

pp. 480.1 ◽

Cited By ~ 4

Author(s):

M Bonati ◽

C Pandolfini

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Trial Register ◽

Compulsory Registration ◽

Clinical Trial Register

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Validation of the UCLA Scleroderma Clinical Trial Gastrointestinal Tract Instrument Version 2.0 for Systemic Sclerosis

The Journal of Rheumatology ◽

10.3899/jrheum.110060.c1 ◽

2011 ◽

Vol 38 (11) ◽

pp. 2498-2498

Keyword(s):

Clinical Trial ◽

Systemic Sclerosis ◽

Gastrointestinal Tract ◽

Version 2.0

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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

Diabetology & Metabolic Syndrome ◽

10.1186/s13098-020-00622-3 ◽

2021 ◽

Vol 13 (1) ◽

Cited By ~ 1

Author(s):

Dafeng Liu ◽

Yong Wang ◽

Bennan Zhao ◽

Lijuan Lan ◽

Yaling Liu ◽

...

Keyword(s):

Diabetes Mellitus ◽

Disease Progression ◽

Poor Prognosis ◽

Lymphocyte Subsets ◽

Severe Disease ◽

Peripheral Lymphocyte ◽

Immunomodulatory Treatment ◽

The Poor ◽

Trial Register ◽

Clinical Trial Register

Abstract 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

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

10.37766/inplasy2022.1.0051 ◽

2022 ◽

Author(s):

RAUL RIBEIRO DE ANDRADE ◽

◽

OLAVO BARBOSA DE OLIVEIRA NETO ◽

JOÃO GUSTAVO ROCHA PEIXOTO DOS SANTOS ◽

CÉLIO FERNANDO DE SOUSA RODRIGUES ◽

...

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Web Of Science ◽

Public Health Problem ◽

Orotracheal Intubation ◽

Early Tracheostomy ◽

Trial Register ◽

Review Question ◽

Clinical Trials Registry ◽

Clinical Trial Register

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).

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Validation of the UCLA Scleroderma Clinical Trial Gastrointestinal Tract Instrument Version 2.0 for Systemic Sclerosis

The Journal of Rheumatology ◽

10.3899/jrheum.110060 ◽

2011 ◽

Vol 38 (9) ◽

pp. 1925-1930 ◽

Cited By ~ 17

Author(s):

MURRAY BARON ◽

MARIE HUDSON ◽

RUSSELL STEELE ◽

ERNEST LO ◽

Keyword(s):

Clinical Trial ◽

Systemic Sclerosis ◽

Gastrointestinal Tract ◽

Los Angeles ◽

Formal Education ◽

Short Form ◽

Health Assessment ◽

Original Cohort ◽

Gi Symptoms ◽

Version 2.0

Objective.The University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium GI Tract Instrument (UCLA SCTC GITI) was recently developed to measure gastrointestinal tract disease in systemic sclerosis (SSc). Our study assesses the internal consistency and validity of the instrument in a different population than was used in the original study.Methods.A sample of 113 consecutive patients with SSc from the Canadian Scleroderma Research Group (CSRG) Registry completed the UCLA SCTC GITI, a self-administered questionnaire with 7 scales and an overall score. Reliability was evaluated using Cronbach’s alpha coefficient and validity was determined by testing multiple constructs.Results.Our subjects were slightly older than the original cohort, and had less formal education and less diffuse cutaneous disease. The overall score of the instrument correlated well with the GI scale of the Health Assessment Questionnaire for the Spondyloarthropathies (GI-S-HAQ; r = 0.58, p < 0.001) and the total number of GI symptoms (r = 0.77, p < 0.001). Each subscale correlated well with the GI-S-HAQ. The individual scales and the overall score were able to differentiate between categorical groupings of the GI-S-HAQ. The scale scores differentiated well those patients with clinical involvement of the corresponding GI problem. Multiple linear regression adjusting for age, disease duration, sex, and ethnicity showed that the UCLA SCTC GITI had a significant association with both the physical component summary and the mental component summary of the Medical Outcomes Study Short-Form 36 questionnaire.Conclusion.Our study confirms that the UCLA SCTC GITI version 2.0 will be a useful tool for assessing the role of GI involvement in SSc, even in a population with substantially different characteristics than the subjects originally tested.

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

European Journal of Public Health ◽

10.1093/eurpub/ckz142 ◽

2019 ◽

Author(s):

Haiqing Zhang ◽

Xinyu Zhao ◽

Yuqian Li ◽

Zhenxing Mao ◽

Wenqian Huo ◽

...

Keyword(s):

Blood Pressure ◽

Clinical Trial ◽

Sleep Duration ◽

Combined Effect ◽

Initiation Time ◽

Night Sleep ◽

Clinical Trial Registration ◽

Registration Number ◽

Adjusted Model ◽

Clinical Trial Register

Abstract 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.

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