a Randomized Controlled Trial
Conditions
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.
Interventions
PROCEDUREComputerized Modified Paramedian Approach Technique
Computerized Modified Paramedian Approach Technique ( CMPAT )
Conventional Midline Approach Technique
Sponsors
Fujian Medical University Union Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The involvement of patients and the public was not or will not be included in the design, implementation, reporting or dissemination of the research.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of puncture attempts in case of successful LP | 1 day |
| LP success rate | 1 day |
Countries
China
Outcome results
None listed