Randomized Control Trial Comparing CMPAT and MAT for Lumbar Puncture
- Conditions
- a Randomized Controlled Trial
- Registration Number
- NCT05795075
- Lead Sponsor
- Fujian Medical University Union Hospital
- Brief Summary
The lumbar puncture (LP) technique is a widely utilized method for diagnosis and treatment purposes. Recently, the paramedian approach technique (PAT) has garnered increasing interest due to its advantages over the midline approach technique (MAT), which has traditionally been used for LP in clinical practice . Utilizing digital virtual human and computer simulation techniques, a new path has been proposed for the computerized modified paramedian approach technique (CMPAT). As such, the objective of the present study is to present a randomized controlled trial (RCT) protocol to investigate and compare the effects of CMPAT versus MAT in patients requiring LP.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 84
- Aged 18-70 years. Indication for LP.（Diagnostic lumbar puncture：Cerebrospinal fluid composition analysis，Cerebrospinal fluid pressure measurement；Cerebrospinal fluid release or lumbar Contiuous drainage of fluid，Intrathecal injection of lumbar cistern, etc.） Informed consent. Sufficient knowledge of the Chinese language to complete forms and follow instructions independently.
- Cerebral hernia or high Cerebrospinal fluid pressure that might lead to Cerebral hernia.
Treatment with oral anticoagulant or anti-small plate(3 days or less)or coagulation disorders, various factors leading to a higher risk of bleeding.
Local infection or skin breakdown. Previous surgery on Lumbar spine segments. Pregnancy or lactation Severe somatic or psychiatric illness.（Severe anxiety or depression, etc.） Failure to be followed up as needed or worries about the potential risks of the study.
Failure to provide written informed consent or follow the protocol requirements.
Expected survival time being less than 1 month. Plan to emigrate within 1 month. Other conditions that are unsuitable for clinical research.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method LP success rate 1 day Number of puncture attempts in case of successful LP 1 day
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Fujian Medical University Union Hospital🇨🇳Fuzhou, Fujian, China