Randomized Control Trial Comparing CMPAT and MAT for Lumbar Puncture

Last updated: August 2, 2023
Sponsor: Fujian Medical University Union Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Conventional Midline Approach Technique

Computerized Modified Paramedian Approach Technique

Clinical Study ID

NCT05795075
ChiCTR2300067937
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18-70 years. Indication for LP.（Diagnostic lumbar puncture：Cerebrospinal fluidcomposition analysis，Cerebrospinal fluid pressure measurement；Cerebrospinal fluidrelease or lumbar Contiuous drainage of fluid，Intrathecal injection of lumbar cistern,etc.） Informed consent. Sufficient knowledge of the Chinese language to complete formsand follow instructions independently.

Exclusion

Exclusion Criteria:

  • Cerebral hernia or high Cerebrospinal fluid pressure that might lead to Cerebralhernia. Treatment with oral anticoagulant or anti-small plate(3 days or less)or coagulationdisorders, various factors leading to a higher risk of bleeding. Local infection or skin breakdown. Previous surgery on Lumbar spine segments. Pregnancy orlactation 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. Otherconditions that are unsuitable for clinical research.

Study Design

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: Conventional Midline Approach Technique
Phase:
Study Start date:
June 30, 2023
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.