a Randomized Controlled TrialNCT05795075
Randomized Control Trial Comparing CMPAT and MAT for Lumbar Puncture
A study testing Computerized Modified Paramedian Approach Technique and Conventional Midline Approach Technique in people with a Randomized Controlled Trial, run by Fujian Medical University Union Hospital at 1 site in China.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- a Randomized Controlled Trial
- What is being tested?
- Computerized Modified Paramedian Approach Technique and Conventional Midline Approach Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Yuan-Dong Zhuang, 15260866029, zhuangyuandong@hotmail.com
About this study
Official title: Computerized Modified Paramedian Approach Technique（CMPAT） Versus Conventional Midline Approach Technique（MAT） of Lumbar Puncture: A Randomized Control Trial
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.
- Conditions
- a Randomized Controlled Trial
- Being tested
- Computerized Modified Paramedian Approach Technique, Conventional Midline Approach Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Modified Paramedian Approach TechniqueProcedure or surgery
Computerized Modified Paramedian Approach Technique ( CMPAT )
Conventional Midline Approach TechniqueProcedure or surgery
Conventional Midline Approach Technique
| Study group | Role | What they receive |
|---|---|---|
| Computerized Modified Paramedian Approach Technique | Experimental | 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. Receives: Procedure: Computerized Modified Paramedian Approach Technique |
| Conventional Midline Approach Technique | Experimental | 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. Receives: Procedure: Conventional Midline Approach Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of puncture attempts in case of successful LP
Measured: 1 day
LP success rate
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start30 Jun 2023
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for a Randomized Controlled TrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795075
- Sponsor's protocol ID
- ChiCTR2300067937
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Modified Paramedian Approach Technique（CMPAT） Versus Conventional Midline Approach Technique（MAT） of Lumbar Puncture: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05795075
- Acronym / sponsor ID
- ChiCTR2300067937
- Conditions
- a Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized Modified Paramedian Approach Technique | Experimental | Procedure: Computerized Modified Paramedian Approach TechniqueThe 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. |
| Conventional Midline Approach Technique | Experimental | Procedure: Conventional Midline Approach TechniquePuncture 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Modified Paramedian Approach TechniqueComputerized Modified Paramedian Approach Technique ( CMPAT ) | Procedure or surgery | Computerized Modified Paramedian Approach Technique |
| Conventional Midline Approach TechniqueConventional Midline Approach Technique | Procedure or surgery | Conventional Midline Approach Technique |
Primary outcome
Number of puncture attempts in case of successful LP
Time frame: 1 day
LP success rate
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Modified Paramedian Approach Technique and Conventional Midline Approach Technique in people with a Randomized Controlled Trial, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of puncture attempts in case of successful LP (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.