BJA open最新文献

筛选
英文 中文
Cardiac coherence and medical hypnosis: a feasibility study of a new combined approach for managing preoperative anxiety in patients with breast or gynaecological cancer 心电协调和医学催眠:针对乳腺癌或妇科癌症患者术前焦虑症管理的新组合方法的可行性研究
BJA open Pub Date : 2024-09-24 DOI: 10.1016/j.bjao.2024.100309
{"title":"Cardiac coherence and medical hypnosis: a feasibility study of a new combined approach for managing preoperative anxiety in patients with breast or gynaecological cancer","authors":"","doi":"10.1016/j.bjao.2024.100309","DOIUrl":"10.1016/j.bjao.2024.100309","url":null,"abstract":"<div><h3>Background</h3><div>Non-pharmaceutical approaches can help manage preoperative anxiety, but few studies have evaluated psychoeducational programmes, especially for cancer surgery. We assessed the feasibility of the COHErence Cardiaque (COHEC) programme where cardiac coherence and medical hypnosis are combined to manage preoperative anxiety in patients undergoing breast or gynaecological cancer surgical interventions (BGCSI).</div></div><div><h3>Methods</h3><div>Patients undergoing BGCSI were enrolled and followed a daily home programme with cardiac coherence and medical hypnosis sessions, starting 7 days before the procedure. The primary endpoint was optimal patient adherence (i.e. completion of ≥14 sessions). Secondary endpoints were anxiety levels, measured using the Visual Analogue Scale (VAS) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS), satisfaction (EVAN-G), and quality of postoperative recovery (QoR-15).</div></div><div><h3>Results</h3><div>In total, 53 patients [mean age: 55 (34–82) yr] were included; 83.7% had breast cancer and 15.1% had gynaecological cancer. Optimal adherence was achieved by 64.2% (95% confidence interval: 49.8–76.9%) of the intention-to-treat population. Among the 43 patients who completed at least one session, exploratory analysis showed that anxiety on the day before (<em>P</em>=0.02) and the morning of the intervention (<em>P</em>=0.04) was decreased in patients with severe anxiety at baseline (VAS ≥70). The median VAS satisfaction score for the programme was 10 (4–10). Overall, 94% of patients were willing to include the COHEC programme in their daily routine.</div></div><div><h3>Conclusions</h3><div>The implementation of a psychoeducational programme combining cardiac coherence and medical hypnosis is feasible and might potentially help patients undergoing BGCSI to manage preoperative anxiety. A randomised trial is underway to assess the efficacy of the COHEC programme.</div></div><div><h3>Clinical trial registration</h3><div>NCT03981731.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2772609624000534/pdfft?md5=435cc270567e1a90f8b237a71511b068&pid=1-s2.0-S2772609624000534-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142314118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Perioperative considerations in the paediatric patient with congenital and acquired coagulopathy 先天性和后天性凝血功能障碍儿科患者的围手术期注意事项
BJA open Pub Date : 2024-09-23 DOI: 10.1016/j.bjao.2024.100310
{"title":"Perioperative considerations in the paediatric patient with congenital and acquired coagulopathy","authors":"","doi":"10.1016/j.bjao.2024.100310","DOIUrl":"10.1016/j.bjao.2024.100310","url":null,"abstract":"<div><div>Neonates, infants, and children undergoing major surgery or with trauma can develop severe coagulopathy perioperatively. Neonates and infants are at highest risk because their haemostatic system is not fully developed and underlying inherited bleeding disorders may not have been diagnosed before surgery. Historically, laboratory coagulation measurements have been used to diagnose and monitor coagulopathies. Contemporary dynamic monitoring strategies are evolving. Viscoelastic testing is increasingly being used to monitor coagulopathy, particularly in procedures with a high risk of bleeding. However, there is a lack of valid age-specific reference values for diagnosis and trigger or target values for appropriate therapeutic management. A promising screening tool of primary haemostasis that may be used to diagnose quantitative and qualitative platelet abnormalities is the <em>in vitro</em> closure time by platelet function analyser. Targeted individualised treatment strategies for haemostatic bleeding arising from inherited or acquired bleeding disorders may include measures such as tranexamic acid, administration of plasma, derived or recombinant factors such as fibrinogen concentrate, or allogeneic blood component transfusions (plasma, platelets, or cryoprecipitate).</div><div>Herein we review current recommended perioperative guidelines, monitoring strategies, and treatment modalities for the paediatric patient with a coagulopathy. In the absence of data from adequately powered prospective studies, it is recommended that expert consensus be considered until additional research and validation of goal-directed perioperative bleeding management in paediatric patients is available.</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2772609624000546/pdfft?md5=1d06f4a239ed2b5ef6bd68b13267da73&pid=1-s2.0-S2772609624000546-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142310935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluation of lung homogeneity in neonates and small infants during general anaesthesia using electrical impedance tomography: a prospective observational study 利用电阻抗断层扫描评估全身麻醉期间新生儿和小婴儿的肺均匀性:一项前瞻性观察研究
BJA open Pub Date : 2024-09-21 DOI: 10.1016/j.bjao.2024.100344
{"title":"Evaluation of lung homogeneity in neonates and small infants during general anaesthesia using electrical impedance tomography: a prospective observational study","authors":"","doi":"10.1016/j.bjao.2024.100344","DOIUrl":"10.1016/j.bjao.2024.100344","url":null,"abstract":"<div><h3>Background</h3><p>Prolonged mechanical ventilation can create heterogeneous ventilation patterns, which increase the risk of lung injury in infants. However, little is understood about the risk of brief exposure to mechanical ventilation during anaesthesia. The aim of this prospective observational study was to describe the regional pattern of lung ventilation during general anaesthesia in healthy neonates and infants, using electrical impedance tomography.</p></div><div><h3>Methods</h3><p>Twenty infants (age 3 days to 12 months), without known lung disease and receiving general anaesthesia with endotracheal intubation for supine positioned surgery, were included in the study. Anaesthesia and ventilation management was at the discretion of the treating clinician. Standardised lung imaging using electrical impedance tomography was made at six time points during anaesthesia from induction to post-extubation. At each time point, the gravity-dependent and right–left lung centre of ventilation was calculated.</p></div><div><h3>Results</h3><p>Tidal ventilation favoured the dorsal lung regions at induction, with a median (inter-quartile range) centre of ventilation (CoV) of 58.2 (53.9–59.3)%. After intubation, there was a redistribution of ventilation to the ventral lung, with the greatest change occurring early in surgery: CoV of 53.8 (52.3–55.2)%. After extubation, CoV returned to pre-intubation values: 56.5 (54.7–58)%. Across all time points, the pattern of ventilation favoured the right lung.</p></div><div><h3>Conclusions</h3><p>General anaesthesia creates heterogenous patterns of ventilation similar to those reported during prolonged mechanical ventilation. This potentially poses a risk for lung injury that may not be recognised clinically. These results suggest the need to better understand the impact of general anaesthesia on the developing lung.</p></div><div><h3>Clinical trial registration</h3><p>Australian New Zealand Clinical Trials Registry (ACTRN 12616000818437, 22 June 2016).</p></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2772609624000881/pdfft?md5=c0680283a94d462b976090bbbaf78733&pid=1-s2.0-S2772609624000881-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142272422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Paediatric perioperative hypersensitivity: the performance of the current consensus formula and the effect of uneventful anaesthesia on serum tryptase. Reply to BJA Open 2024; 9: 100254 儿科围手术期超敏反应:当前共识公式的性能以及无痛麻醉对血清胰蛋白酶的影响。回复 BJA Open 2024; 9: 100254
BJA open Pub Date : 2024-09-20 DOI: 10.1016/j.bjao.2024.100308
{"title":"Paediatric perioperative hypersensitivity: the performance of the current consensus formula and the effect of uneventful anaesthesia on serum tryptase. Reply to BJA Open 2024; 9: 100254","authors":"","doi":"10.1016/j.bjao.2024.100308","DOIUrl":"10.1016/j.bjao.2024.100308","url":null,"abstract":"","PeriodicalId":72418,"journal":{"name":"BJA open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2772609624000522/pdfft?md5=c4654bf9de9875d669e57f92c03b2feb&pid=1-s2.0-S2772609624000522-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142272423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
An update on iron therapy as an intervention to reduce blood transfusion for patients undergoing hip fracture surgery 铁疗法作为减少髋部骨折手术患者输血的干预措施的最新进展
BJA open Pub Date : 2024-09-20 DOI: 10.1016/j.bjao.2024.100311
{"title":"An update on iron therapy as an intervention to reduce blood transfusion for patients undergoing hip fracture surgery","authors":"","doi":"10.1016/j.bjao.2024.100311","DOIUrl":"10.1016/j.bjao.2024.100311","url":null,"abstract":"","PeriodicalId":72418,"journal":{"name":"BJA open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2772609624000558/pdfft?md5=305ae27cefa154f392c56e8fb38e60ac&pid=1-s2.0-S2772609624000558-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142272424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Serum tryptase changes in children with suspected perioperative hypersensitivity. Comment on BJA Open 2024; 9: 100254 怀疑围手术期过敏的儿童血清色氨酸酶变化评论 BJA Open 2024; 9: 100254
BJA open Pub Date : 2024-09-11 DOI: 10.1016/j.bjao.2024.100307
{"title":"Serum tryptase changes in children with suspected perioperative hypersensitivity. Comment on BJA Open 2024; 9: 100254","authors":"","doi":"10.1016/j.bjao.2024.100307","DOIUrl":"10.1016/j.bjao.2024.100307","url":null,"abstract":"","PeriodicalId":72418,"journal":{"name":"BJA open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2772609624000510/pdfft?md5=e55333ba636abad16afc694c71a61c5b&pid=1-s2.0-S2772609624000510-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142168437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effect of neuromodulation for chronic pain on the autonomic nervous system: a systematic review 神经调节治疗慢性疼痛对自律神经系统的影响:系统综述
BJA open Pub Date : 2024-09-01 DOI: 10.1016/j.bjao.2024.100305
{"title":"Effect of neuromodulation for chronic pain on the autonomic nervous system: a systematic review","authors":"","doi":"10.1016/j.bjao.2024.100305","DOIUrl":"10.1016/j.bjao.2024.100305","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;p&gt;In recent years, there has been a growing interest in the use of neuromodulation as an alternative treatment option for chronic pain. Neuromodulation techniques, such as spinal cord stimulation (SCS), dorsal root ganglion (DRG) stimulation, deep brain stimulation (DBS), and peripheral nerve stimulation, have shown promising results in the management of various chronic pain conditions and involve targeted modulation of neural activity to alleviate pain and restore functional capacity. The autonomic nervous system (ANS) plays a crucial role in the regulation of various bodily functions including pain perception. However, the effects of neuromodulation on the ANS in the context of chronic pain remain poorly understood. This systematic review aimed to comprehensively assess the existing literature about the effects of neuromodulation on the ANS in chronic pain settings.&lt;/p&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;p&gt;Searches were conducted using four electronic databases (PubMed, EMBASE, SCOPUS, and Web of Science). The study protocol was registered before initiation of the review process. The Office of Health Assessment and Translation (OHAT) Risk of Bias tool was used to evaluate risk of bias.&lt;/p&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;p&gt;A total of 43 studies were included, of which only one was an animal study. Several studies have reported more than one outcome parameter in the same population of chronic pain patients. Cardiovascular parameters were the most frequently used outcomes. More specifically, 18 outcome parameters were revealed to evaluate the function of the ANS, namely heart rate variability (&lt;em&gt;n&lt;/em&gt;=17), arterial blood pressure (&lt;em&gt;n&lt;/em&gt;=15), tissue oxygenation/perfusion (&lt;em&gt;n&lt;/em&gt;=5), blood markers (&lt;em&gt;n&lt;/em&gt;=6), multiunit postganglionic sympathetic nerve activity (&lt;em&gt;n&lt;/em&gt;=4), skin temperature (&lt;em&gt;n&lt;/em&gt;=3), skin conductance (&lt;em&gt;n&lt;/em&gt;=3), cephalic autonomic symptoms (&lt;em&gt;n&lt;/em&gt;=2), ventilatory frequency (&lt;em&gt;n&lt;/em&gt;=2), vasomotor tone (&lt;em&gt;n&lt;/em&gt;=1), baroreflex sensitivity (&lt;em&gt;n&lt;/em&gt;=1), sympathetic innervation of the heart, neural activity of intrinsic cardiac neurons (&lt;em&gt;n&lt;/em&gt;=1), vascular conductance (&lt;em&gt;n&lt;/em&gt;=1), arterial diameter (&lt;em&gt;n&lt;/em&gt;=1), blood pulse volume (&lt;em&gt;n&lt;/em&gt;=1), and vagal efficiency (&lt;em&gt;n&lt;/em&gt;=1). Most studies evaluated SCS (62.79%), followed by DBS (18.6%), peripheral nerve stimulation (9.3%), DRG stimulation (4.65%), and vagus nerve stimulation (4.65%). Overall, inconsistent results were revealed towards contribution of SCS, DBS, and peripheral nerve stimulation on ANS parameters. For DRG stimulation, included studies pointed towards a decrease in sympathetic activity.&lt;/p&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;&lt;p&gt;There are indications that neuromodulation alters the ANS, supported by high or moderate confidence in the body of evidence, however, heterogeneity in ANS outcome measures drives towards inconclusive results. Further research is warranted to elucidate the indirect or direct mechanisms of ","PeriodicalId":72418,"journal":{"name":"BJA open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2772609624000492/pdfft?md5=20ae858320b29e303cd0fa605709276a&pid=1-s2.0-S2772609624000492-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142122324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Variable positive end-expiratory pressure in an experimental model of acute respiratory distress syndrome: an advanced ventilation modality 急性呼吸窘迫综合征实验模型中的可变呼气末正压:一种先进的通气模式
BJA open Pub Date : 2024-08-14 DOI: 10.1016/j.bjao.2024.100302
{"title":"Variable positive end-expiratory pressure in an experimental model of acute respiratory distress syndrome: an advanced ventilation modality","authors":"","doi":"10.1016/j.bjao.2024.100302","DOIUrl":"10.1016/j.bjao.2024.100302","url":null,"abstract":"<div><h3>Background</h3><p>Introducing variability in tidal volume, ventilatory frequency, or both is beneficial during mechanical ventilation in acute respiratory distress syndrome (ARDS). We investigated whether applying cycle-by-cycle variability in the positive end-expiratory pressure (PEEP) exerts beneficial effect on lung function in a model of ARDS.</p></div><div><h3>Methods</h3><p>Rabbits with lung injury were randomly allocated to receive mechanical ventilation for 6 h by applying a pressure-controlled mode with constant PEEP of 7 cm H<sub>2</sub>O (PC group: <em>n</em>=6) or variable PEEP (VEEP) with a coefficient of variation of 21.4%, range 4–10 cm H<sub>2</sub>O (PC-VEEP group; <em>n</em>=6). Lung oxygenation index (<em>P</em>a<span>o</span><sub>2</sub>/FiO<sub>2</sub>) after 6 h of ventilation (H6) was the primary outcome and respiratory mechanics, lung volume, intrapulmonary shunt, and lung inflammatory markers were secondary outcomes.</p></div><div><h3>Results</h3><p>After lung injury, both groups presented moderate-to-severe ARDS (<em>P</em>a<span>o</span><sub>2</sub>/FiO<sub>2</sub> &lt;27 kPa). The <em>P</em>a<span>o</span><sub>2</sub>/FiO<sub>2</sub> was significantly higher in the PC-VEEP group than in the PC group at H6 (12.3 [<span>sd</span> 3.5] <em>vs</em> 19.2 [7.2] kPa, <em>P</em>=0.013) and a lower arterial partial pressure of CO<sub>2</sub> at 1–3 h (<em>P</em>&lt;0.02). The ventilation-induced increases in airway resistance and tissue elastance were prevented by PC-VEEP. There was no evidence for a difference in minute volume, driving pressure, end-tidal CO<sub>2</sub>, lung volumes, intrapulmonary shunt fraction, and cytokines between the ventilation modes.</p></div><div><h3>Conclusions</h3><p>Prolonged mechanical ventilation with cycle-by-cycle VEEP prevents deterioration in gas exchange and respiratory mechanics in a model of ARDS, suggesting the benefit of this novel ventilation strategy to optimise gas exchange without increasing driving pressure and lung overdistension.</p></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2772609624000467/pdfft?md5=bb75ea3ad3c8a7e3b54a06862b85ba1d&pid=1-s2.0-S2772609624000467-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141985402","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
International Delirium Pathophysiology & Electrophysiology Network for Data sharing (iDEPEND) 国际谵妄病理生理学和电生理学数据共享网络 (iDEPEND)
BJA open Pub Date : 2024-07-30 DOI: 10.1016/j.bjao.2024.100304
{"title":"International Delirium Pathophysiology & Electrophysiology Network for Data sharing (iDEPEND)","authors":"","doi":"10.1016/j.bjao.2024.100304","DOIUrl":"10.1016/j.bjao.2024.100304","url":null,"abstract":"<div><p>In an era of ‘big data’, we propose that a collaborative network approach will drive a better understanding of the mechanisms of delirium, and more rapid development of therapies. We have formed the International Delirium Pathophysiology &amp; Electrophysiology Network for Data sharing (iDEPEND) group with a key aim to ‘facilitate the study of delirium pathogenesis with electrophysiology, imaging, and biomarkers including data acquisition, analysis, and interpretation’. Our initial focus is on studies of electrophysiology as we anticipate this methodology has great potential to enhance our understanding of delirium. Our article describes this principle and is used to highlight the endeavour to the wider community as we establish key stakeholders and partnerships.</p></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2772609624000480/pdfft?md5=f38de960f93fc7356b70bf01f677be3c&pid=1-s2.0-S2772609624000480-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141952063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Postoperative intravenous iron to treat iron-deficiency anaemia in patients undergoing cardiac surgery: a protocol for a pilot, multicentre, placebo-controlled randomized trial (the POAM trial) 治疗心脏手术患者缺铁性贫血的术后静脉注射铁剂:多中心安慰剂对照随机试验(POAM 试验)方案
BJA open Pub Date : 2024-07-27 DOI: 10.1016/j.bjao.2024.100303
{"title":"Postoperative intravenous iron to treat iron-deficiency anaemia in patients undergoing cardiac surgery: a protocol for a pilot, multicentre, placebo-controlled randomized trial (the POAM trial)","authors":"","doi":"10.1016/j.bjao.2024.100303","DOIUrl":"10.1016/j.bjao.2024.100303","url":null,"abstract":"<div><h3>Background</h3><p>Iron-deficiency anaemia, occurring in 30–40% of patients undergoing cardiac surgery, is an independent risk factor for adverse outcomes. Our long-term goal is to assess if postoperative i.v. iron therapy improves clinical outcomes in patients with preoperative iron-deficiency anaemia undergoing cardiac surgery. Before conducting a definitive RCT, we first propose a multicentre pilot trial to establish the feasibility of the definitive trial.</p></div><div><h3>Methods</h3><p>This internal pilot, double-blinded, RCT will include three centres. Sixty adults with preoperative iron-deficiency anaemia undergoing non-emergency cardiac surgery will be randomised on postoperative day 2 or 3 to receive either blinded i.v. iron (1000 mg ferric derisomaltose) or placebo. Six weeks after surgery, patients who remain iron deficient will receive a second blinded dose of i.v. iron according to their assigned treatment arm. Patients will be followed for 12 months. Clinical practice will not be otherwise modified. For the pilot study, feasibility will be assessed through rates of enrolment, protocol deviations, and loss to follow up. For the definitive study, the primary outcome will be the number of days alive and out of hospital at 90 days after surgery.</p></div><div><h3>Ethics and dissemination</h3><p>The trial has been approved by the University Health Network Research Ethics Board (REB # 22-5685; approved by Clinical Trials Ontario funding on 22 December 2023) and will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practices guidelines, and regulatory requirements.</p></div><div><h3>Clinical trial registration</h3><p>NCT06287619.</p></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2772609624000479/pdfft?md5=d58c47a1c668bf884171cd664f423875&pid=1-s2.0-S2772609624000479-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141954596","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
相关产品
×
本文献相关产品
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信