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临床试验/DRKS00014941
DRKS00014941已完成未知

Pneumothorax rates in neurosurgical patients with infraclavicular subclavian catheterization. A comparison of continued mechanical ventilation to apnea during puncture: A prospective, randomized, controlled non-inferiority trial - Subclavian CVC and ventilation

Medizinische Hochschule Hannover0 个研究点目标入组 1,048 人开始时间: 2018年6月19日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
1,048

研究概览

简要总结

Background. Infraclavicular subclavian vein (SCV) catheterization is a standard procedure in anesthesia and intensive care. There is a lack of evidence on how mechanical ventilation during venipuncture of the SCV influences pneumothorax rates. Objective. Primary hypothesis: non-inferiority of continuing vs. discontinuingmechanical ventilation during infraclavicular puncture of the SCV with respect to the pneumothorax rate. Material and methods. This prospective, randomized and single-blinded study was approved by the local ethics committee. A total of 1021 eligible patients who underwent cranial neurosurgery in 2 different university hospitals were assessed between August 2014 and October 2017. Patients were randomly assigned to two groups directly before induction of anesthesia. Intervention groups for venipuncture of the SCV were mechanical ventilation: tidal volume 7 ml/kg ideal body weight, positive end expiratory pressure (PEEP) ideal body weight/10, n= 535, or apnea: manual/spontaneous, APL valve 0mbar, n= 486. Patients and the physicians who assessed pneumothorax rates were blinded to the intervention group. Venipuncture was carried out by both inexperienced and experienced physicians. Results. The pneumothorax rate was significantly higher in the mechanical ventilation group (2.2% vs. 0.4%; p= 0.012) with an odds ratio (OR) of 5.63 (95% confidence interval, CI: 1.17–27.2; p= 0.031). A lower body mass index (BMI) was associated with a higher pneumothorax rate, OR 0.89 (95% CI: 0.70–0.96; p= 0.013). Conclusion. In this study landmark-guided infraclavicular SCV catheterization was associated with a significantly higher rate of pneumothorax when venipuncture was performed during mechanical ventilation and not in apnea. If a short phase of apnea is justifiable in the patient, mechanical ventilation should be discontinued during the venipuncture procedure. Keywords Central venous catheter · Subclavian vein · Pneumothorax · Complication

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • An elective intracranial intervention with the necessity of a CVC.
  • Written informed consent of the patient

排除标准

  • infections or anatomical abnormalities at the puncture site
  • history of clavicle fracture
  • Pregnancy
  • Neurological disorders with a lack of self-determination

研究者

发起方
Medizinische Hochschule Hannover

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