View clinical trials related to Spinal Puncture Complications.
Filter by:Nusinersen (Spinraza, Biogen Inc, Boston, MA), the first treatment approved by FDA and EMA for all Spinal Muscular Atrophy (SMA) subtypes, is an antisense oligonucleotide that is administered intrathecally through a lumbar puncture. This procedure can be challenging in some adults with intermediate and late onset SMA (types II-IV) frequently presenting scoliosis secondary to neuromuscular weakness and often treated with spinal instrumentation to prevent worsening deformities. In such patients, in order to access the intrathecal space, US guidance and/or assistance have been recently proposed as useful and successful tool. The US guidance and/or assistance have been associated to a high success rate, a reduction of number of attempts and needle passes to obtain a successful anesthesia. A reduced risk of adverse events (AEs), such as post dural puncture headache (PDPH) and low back pain (LBP), and low patient satisfaction often associated with multiple needle punctures was also reported. Aim of this retrospective study was to report the efficacy, evaluated as rate of the successful procedures and subsequent delivery of nusinersen within the subarachnoid space, the number of attempts, the procedure time and the adverse events (AEs) of interlaminar intrathecal nusinersen administration using either ultrasound assistance or the landmark-based technique in a historical cohort of 51 adult SMA patients.
This study will investigate the effect of simulation-based training with mastery learning (SBML) on novice performers' lumbar puncture (LP) performance in a clinical setting. The study will investigate the effect on operators' performance, stress level, and on patient experienced stress, confidence in operator, and patient-related outcomes of pain, and risk of subsequent Post Dural Puncture Headache (PDPH), and days of sickness leave. The study will compare the effect of the training to a control group of novices receiving standard training and additionally to an intermediate and an expert group. The study will provide insight into the translational effect from the simulation based setting to clinical performance. Further, the study will explore: if stress decreases operators' performance; if operators stress affects the patient stress level; and the effect of SBML on patient-related outcomes.
The study is carried out in a prospectively randomly controlled way. In the context of acknowledgement and understanding from parents, by comparing with traditional process (lying without the pillow and fasting water and food for four hours following lumbar puncture), an optimized postoperative management (lying without the pillow for half an hour following lumbar puncture) is randomly selected. All children will be evaluated by the FLACC (The face, legs, activity, cry, consolability behavioral tool) scale to assess the degree of pain after lumbar puncture. Any postoperative condition will be recorded and analyzed. A questionaire about bad memory during lumbar puncture for all parents and children will be investigated in order to establish an optimized lumbar puncture management process.
The study is carried out in a prospective randomized controlled way. In the context of informed understanding from parents, compared with traditional process(no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture), randomly select lidocaine surface anesthesia and postoperative management (lying without the pillow for half an hour after lumbar puncture) . All children will be evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale to assess the degree of pain during and after lumbar puncture. Lumber puncture time, success rate and any postoperative condition will be recorded and analyzed.A questionaire about the operation for all parents and children will be investigated in order to establish an optimized lumbar puncture management process.
The purpose of this study is to determine if performing an ultrasound to identify the space to insert the needle before performing a lumbar puncture will improve success of the procedure and patient safety.