scholarly journals Inhaled amikacin versus placebo to prevent ventilator-associated pneumonia: the AMIKINHAL double-blind multicentre randomised controlled trial protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e048591
Author(s):  
Elsa Tavernier ◽  
Francois Barbier ◽  
Ferhat Meziani ◽  
Jean-Pierre Quenot ◽  
Jean-Etienne Herbrecht ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Invasive Mechanical Ventilation ◽  
Small Sample ◽  
Resistant Bacteria ◽  
Ventilator Associated Pneumonia ◽  
Double Blind ◽  
Inhaled Antibiotics ◽  
Randomised Controlled ◽  
Inhaled Amikacin

IntroductionPre-emptive inhaled antibiotics may be effective to reduce the occurrence of ventilator-associated pneumonia among critically ill patients. Meta-analysis of small sample size trials showed a favourable signal. Inhaled antibiotics are associated with a reduced emergence of antibiotic resistant bacteria. The aim of this trial is to evaluate the benefit of a 3-day course of inhaled antibiotics among patients undergoing invasive mechanical ventilation for more than 3 days on the occurrence of ventilator-associated pneumonia.Methods and analysisAcademic, investigator-initiated, parallel two group arms, double-blind, multicentre superiority randomised controlled trial. Patients invasively ventilated more than 3 days will be randomised to receive 20 mg/kg inhaled amikacin daily for 3 days or inhaled placebo (0.9% Sodium Chloride). Occurrence of ventilator-associated pneumonia will be recorded based on a standardised diagnostic framework from randomisation to day 28 and adjudicated by a centralised blinded committee.Ethics and disseminationThe protocol and amendments have been approved by the regional ethics review board and French competent authorities (Comité de protection des personnes Ouest I, No.2016-R29). All patients will be included after informed consent according to French law. Results will be disseminated in international scientific journals.Trial registration numbersEudraCT 2016-001054-17 and NCT03149640.

scholarly journals Safety and efficacy of tranexamic acid in paediatric cardiac surgery: study protocol for a double-blind randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e032642
Author(s):  
Yu Zhang ◽  
Yuan Jia ◽  
Jia Shi ◽  
Su Yuan ◽  
Rong Wang ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Randomised Controlled Trial ◽  
Tranexamic Acid ◽  
Controlled Trial ◽  
Small Sample ◽  
Double Blind ◽  
End Point ◽  
Paediatric Patients ◽  
Paediatric Cardiac Surgery ◽  
Randomised Controlled

IntroductionAn initial retrospective study suggested that tranexamic acid (TXA) administration increased the incidence of seizures in paediatric patients undergoing cardiac surgery. However, the efficacy of TXA in paediatric cardiac surgery remains unclear owing to the small sample sizes of the studies. Therefore, this study will investigate the efficacy and safety of TXA in paediatric patients undergoing cardiac surgery. We hypothesised that TXA may increase the incidence of postoperative seizures with no effect on postoperative allogeneic transfusion in paediatric patients undergoing cardiac surgery. The pragmatic study will provide important implications for paediatric cardiac surgery.Methods and analysisThis will be a single-centre prospective, double-blind randomised controlled trial. The plan is to enrol in the study 2090 paediatric patients aged 31 days to 7 years who will be undergoing cardiac surgery with cardiopulmonary bypass (CPB). All eligible participants will be randomly assigned to either the TXA or placebo group by using a Web-based randomisation service in a 1:1 ratio. The primary safety end point will be postoperative seizures until hospital discharge, and the primary efficacy end point will be the volume of allogeneic red blood cell transfusion after termination of CPB. All patients will be followed up for 1 year postdischarge. All data will be analysed in accordance with the intention-to-treat principle.Ethics and disseminationThis study was approved by the institutional review board of Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (No 20191195). Written informed consent will be obtained from the parents/legal guardian of each patient because all participants will be <18 years of age. The results of the trial will be published in an international peer-reviewed journal.Trial registration numberChinese Clinical Trial Register (ChiCTR1900024131).

scholarly journals Patient-specific instrumentation (PSI) Referencing High Tibial Osteotomy Technological Transfer and Education: protocol for a double-blind, randomised controlled trial (PROTECTED HTO Trial)

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041129
Author(s):  
Lawrence Chun Man Lau ◽  
Elvis Chun Sing Chui ◽  
Jason Chi Ho Fan ◽  
Gene Chi Wai Man ◽  
Yuk Wah Hung ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Knee Osteoarthritis ◽  
High Tibial Osteotomy ◽  
Controlled Trial ◽  
Patient Specific ◽  
Tibial Osteotomy ◽  
Double Blind ◽  
Patient Specific Instrumentation ◽  
3D Printed ◽  
Randomised Controlled

IntroductionHigh tibial osteotomy (HTO) is a treatment of choice for active adult with knee osteoarthritis. With advancement in CT imaging with three-dimensional (3D) model reconstruction, virtual planning and 3D printing, patient-specific instrumentation (PSI) in form of cutting jigs is employed to improve surgical accuracy and outcome of HTO. The aim of this randomised controlled trial (RCT) is to explore the surgical outcomes of HTO for the treatment of medial compartment knee osteoarthritis with or without a 3D printed patient-specific jig.Methods and analysisA double-blind RCT will be conducted with patients and outcome assessors blinded to treatment allocation. This meant that neither the patients nor the outcome assessors would know the actual treatment allocated during the trial. Thirty-six patients with symptomatic medial compartment knee osteoarthritis fulfilling our inclusion criteria will be invited to participate the study. Participants will be randomly allocated to one of two groups (1:1 ratio): operation with 3D printed patient-specific jig or operation without jig. Measurements will be taken before surgery (baseline) and at postoperatively (6, 12 and 24 months). The primary outcome includes radiological accuracy of osteotomy. Secondary outcomes include a change in knee function from baseline to postoperatively as measured by three questionnaires: Knee Society Scores (Knee Scores and Functional Scores), Oxford Knee Scores and pain visual analogue scale (VAS) score.Ethics and disseminationEthical approval has been obtained from the Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (CREC no. 2019.050), in accordance with the Declaration of Helsinki. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.Trial registration numberNCT04000672; Pre-results.

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