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
- Conditions
- infraclavicular subclavian catheterizationJ95.80
- Registration Number
- DRKS00014941
- Lead Sponsor
- Medizinische Hochschule Hannover
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1048
• An elective intracranial intervention with the necessity of a CVC.
• Written informed consent of the patient
• infections or anatomical abnormalities at the puncture site
• history of clavicle fracture
• Pregnancy
• Neurological disorders with a lack of self-determination
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative pneumothorax rate (Sonographic detection/ exclusion of a pneumothorax with image evidence (acoustic window: ventral: 3rd-4th ICR medioclavicular with image documentation) or chest radiography within the first 24h postoperatively
- Secondary Outcome Measures
Name Time Method • Hit rate at the first puncture<br>• Number of punctures to success<br>• Number of arterial punctures<br>• Failure and changing the puncture site