Randomized Control Trial Comparing CMPAT and MAT for Lumbar Puncture

Sponsor

Fujian Medical University Union Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05795075

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
a Randomized Controlled Trial	Procedure: Computerized Modified Paramedian Approach Technique Procedure: Conventional Midline Approach Technique	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, 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.

Primary Purpose:

Treatment

Official Title:

Computerized Modified Paramedian Approach Technique（CMPAT） Versus Conventional Midline Approach Technique（MAT） of Lumbar Puncture: A Randomized Control Trial

Anticipated Study Start Date :

Mar 30, 2023

Anticipated Primary Completion Date :

Mar 30, 2024

Anticipated Study Completion Date :

Mar 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Computerized Modified Paramedian Approach Technique The L3-4 inter-laminar space will be selected as the target for puncture, and in the longitudinal direction, 1.0-1.5cm will be opened beside the upper edge of the spinous process (tip) of the lower vertebra as the entry point. The lumbar puncture needle will be inserted vertically along the axis of the anesthesia needle. The puncture path will be maintained completely perpendicular to the skin until the needle reached the PLTLF (posterior layer of the thoracolumbar fascia), where some resistance will be felt. The puncture direction is adjusted as needed. The tip of the needle will be tilted 20±10° in the sagittal direction and 15±5° inward such that the tip will point at the midpoint of the spinal canal. After the needle reaches the PLTLF, it will be further inserted 3-7 cm.	Procedure: Computerized Modified Paramedian Approach Technique Computerized Modified Paramedian Approach Technique ( CMPAT )
Experimental: Conventional Midline Approach Technique Puncture will be performed on the posterior median line near the midpoint of the L3-4 Space of spinous process. The lumbar puncture needle will be inserted vertically along the axis of the anesthesia needle, or the tip of the needle will be tilted 15° in the sagittal direction toward the head, so that the needle path is parallel to the space of spinous process.	Procedure: Conventional Midline Approach Technique Conventional Midline Approach Technique

Arm

Intervention/Treatment

Experimental: Computerized Modified Paramedian Approach Technique

The L3-4 inter-laminar space will be selected as the target for puncture, and in the longitudinal direction, 1.0-1.5cm will be opened beside the upper edge of the spinous process (tip) of the lower vertebra as the entry point. The lumbar puncture needle will be inserted vertically along the axis of the anesthesia needle. The puncture path will be maintained completely perpendicular to the skin until the needle reached the PLTLF (posterior layer of the thoracolumbar fascia), where some resistance will be felt. The puncture direction is adjusted as needed. The tip of the needle will be tilted 20±10° in the sagittal direction and 15±5° inward such that the tip will point at the midpoint of the spinal canal. After the needle reaches the PLTLF, it will be further inserted 3-7 cm.

Procedure: Computerized Modified Paramedian Approach Technique

Computerized Modified Paramedian Approach Technique ( CMPAT )

Experimental: Conventional Midline Approach Technique

Puncture will be performed on the posterior median line near the midpoint of the L3-4 Space of spinous process. The lumbar puncture needle will be inserted vertically along the axis of the anesthesia needle, or the tip of the needle will be tilted 15° in the sagittal direction toward the head, so that the needle path is parallel to the space of spinous process.

Procedure: Conventional Midline Approach Technique

Conventional Midline Approach Technique

Outcome Measures

Primary Outcome Measures

Number of puncture attempts in case of successful LP [1 day]
LP success rate [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fujian Medical University Union Hospital	Fuzhou	Fujian	China

Sponsors and Collaborators

Fujian Medical University Union Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fujian Medical University Union Hospital

ClinicalTrials.gov Identifier:

NCT05795075

Other Study ID Numbers:

ChiCTR2300067937

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 3, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 3, 2023