HydrocephalusIn-VentNCT01973764
Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System
A study testing Ultrasound guided ventricular drain insertion and landmark-based ventricular drain insertion in people with Hydrocephalus and Intracranial Hypertension, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Puncture of the ventricular system is one of the most frequently performed neurosurgical interventions. This procedure is commonly performed in order to treat and/or measure pathologically elevated intracranial pressure.Therefore a safe and fast surgical procedure is needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hydrocephalus, Intracranial Hypertension
- What is being tested?
- Ultrasound guided ventricular drain insertion and landmark-based ventricular drain insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2013to May 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/= 18 years
- Intraventricular catheter insertion or/and intraventricular pressure measurement indicated
- Written informed consent
Who cannot join
- Age < 18 years
- previous ventricular punction < 4 weeks
- bedside puncture indicated
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Neurosurgery, Bern University Hospital
Bern, 3000
About this study
Official title: Intraventricular Drain Insertion:Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System. A Prospective Randomised Clinical Trial Study.
Puncture of the ventricular system is one of the most frequently performed neurosurgical interventions. This procedure is commonly performed in order to treat and/or measure pathologically elevated intracranial pressure.Therefore a safe and fast surgical procedure is needed. Currently the "landmark-based" placement of intraventricular catheters is the gold standard. However it is known that more than 60% of the catheters are not accurately placed in accordance with "landmark-based" procedures. When the catheter is not placed accurately multiple punctures may be required. In this study, the investigators aim to investigate prospectively whether ultrasound guidance leads to a lower number of incorrect catheter placements, and whether this guidance consequently decreases the number of punctures.
Read the detailed description
Background
Puncture of the ventricular system is one of the most frequently performed neurosurgical interventions. This procedure is performed in order to treat and/or measure pathologically elevated intracranial pressure. Therefore a safe and fast surgical procedure is needed. Currently the "landmark-based" placement of intraventricular catheters is the gold standard. Nonetheless it is known that more than 60% of the catheters are not placed accurately performing "landmark-based" procedures. When the catheter is not placed accurately multiple punctures may has to be done.
Puncture of the ventricular system is one of the most frequently performed neurosurgical interventions. This procedure is commonly performed in order to treat and/or measure pathologically elevated intracranial pressure. Therefore a safe and fast surgical procedure is needed.Currently the "landmark-based" placement of intraventricular catheters is the gold standard. Nonetheless it is known that more than 60% of the catheters are not placed accurately performing "landmark-based" procedures. When the catheter is not placed accurately multiple punctures may be required. Incorrectly placed intraventricular catheters may lead to undesirable side effects like catheter dysfunction,in which case a correction of the catheter position or a even a new puncture will be required. These corrections increase the risk of intracerebral hemorrhages, infections or secondary brain injuries. In this study, the investigators will prospectively investigate whether ultrasound guidance increases the number of well-placed ventricular catheters and reduces the number of undesirable side effects. In this study the correct catheter position is defined when the catheter tip is located in the lateral ventricle (ipsilateral to the burrhole) anterior of the foramen of Monro. Catheter tip position will be assessed by cranial computer tomography after the operation. The CT scans will be evaluated by an independent expert rater, blinded for the procedure type. These incorrectly placed intraventricular catheters may lead to undesirable side effects, like catheter dysfunction wherefore a correction of the catheter position or a even a new puncture has to be done. These corrections increase the risk of intracerebral hemorrhages, infections or secondary brain damages.
In this study, the investigators will prospectively investigate if ultrasound guidance may raise the number of well placed ventricular catheters and may reduce the number of undesirable side effects. In this study the correct catheter position is defined when the catheter tip is located in the ipsilateral lateral ventricle (to the burrhole) anterior of the foramen of monroi and will be assessed by cranial computer tomography after operation. The CT Scans will be evaluated by an independent expert rater, blinded for the procedure type.
Objective
Aim of the study is to investigate whether ultrasound guidance of ventricular catheter placement leads to a lower number of incorrectly placed catheters and lower number of punctures compared to the landmark-based procedure.
Methods
This study is a prospective randomized controlled clinical trial. A total of 90 patients will be included in the study and randomized in two groups with 45 patients each (ultrasound-guided group and landmark-based group). The position of the ventricular catheter will be assessed using cranial computer tomography (CCT). The CT Scans will be evaluated by two independent expert raters, blinded for the procedure type.
- Conditions
- Hydrocephalus, Intracranial Hypertension
- Being tested
- Ultrasound guided ventricular drain insertion, landmark-based ventricular drain insertion
- Keywords
- Intraoperative ultrasound, Ventricular System, Puncture, Ventricular catheter, Ventriculostomy, Hydrocephalus, Excessive accumulation of cerebrospinal fluids within the cranium. Often associated with dilatation of cerebral ventricles, Intracranial Hypertension, increased pressure within the cranial vault. This may result from several conditions, including hydrocephalus, brain edema.
- Medical subject headings
- Hydrocephalus, Intracranial Hypertension, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided ventricular drain insertionProcedure or surgery
Ventricular puncture and insertion of the intraventricular catheter is performed under ultrasound guidance.
landmark-based ventricular drain insertionProcedure or surgery
Ventricular puncture and insertion of the intraventricular catheter is performed without any guiding devices and is based on anatomical landmarks.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided arm | Other | Not described Receives: Procedure: Ultrasound guided ventricular drain insertion |
| Landmark-based arm | Other | Not described Receives: Procedure: landmark-based ventricular drain insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correct ventricular catheter position (on post op CT) after single ventricular puncture.
Measured: 48 h after initial operation
Secondary outcomes (5)
Number of catheter changes
Measured: at hospital discharge, expected to be after 10 days
Number of infections
Measured: at hospital discharge, expected to be after 10 days
Number of days in clinic
Measured: at hospital discharge, expected to be after 10 days
Number of ventricular punctures
Measured: "at the end of the operation, expected to be after 1 hour"
Number of patients with intracerebral hemorrhage
Measured: 24 h after initial operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2019
- Study completionMay 2019
Why it stopped: Study was stopped due to slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jürgen Beck, MD, Principal investigator, Dep. of Neurosurgery, University Hospital BernAndreas Raabe, MD, Study director, Dep. of Neurosurgery, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973764
- Sponsor's protocol ID
- 073/13
- Acronym
- In-Vent
- Status last verified
- Aug 2019
- First submitted
- 25 Oct 2013
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Toma AK, Camp S, Watkins LD, Grieve J, Kitchen ND. External ventricular drain insertion accuracy: is there a need for change in practice? Neurosurgery. 2009 Dec;65(6):1197-200; discussion 1200-1. doi: 10.1227/01.NEU.0000356973.39913.0B.
PubMed 19934980Sekhar LN, Moossy J, Guthkelch AN. Malfunctioning ventriculoperitoneal shunts. Clinical and pathological features. J Neurosurg. 1982 Mar;56(3):411-6. doi: 10.3171/jns.1982.56.3.0411.
PubMed 7057239Pang D, Grabb PA. Accurate placement of coronal ventricular catheter using stereotactic coordinate-guided free-hand passage. Technical note. J Neurosurg. 1994 Apr;80(4):750-5. doi: 10.3171/jns.1994.80.4.0750.
PubMed 8151359Huyette DR, Turnbow BJ, Kaufman C, Vaslow DF, Whiting BB, Oh MY. Accuracy of the freehand pass technique for ventriculostomy catheter placement: retrospective assessment using computed tomography scans. J Neurosurg. 2008 Jan;108(1):88-91. doi: 10.3171/JNS/2008/108/01/0088.
PubMed 18173315Wilson TJ, Stetler WR Jr, Al-Holou WN, Sullivan SE. Comparison of the accuracy of ventricular catheter placement using freehand placement, ultrasonic guidance, and stereotactic neuronavigation. J Neurosurg. 2013 Jul;119(1):66-70. doi: 10.3171/2012.11.JNS111384. Epub 2013 Jan 18.
PubMed 23330995Strowitzki M, Moringlane JR, Steudel W. Ultrasound-based navigation during intracranial burr hole procedures: experience in a series of 100 cases. Surg Neurol. 2000 Aug;54(2):134-44. doi: 10.1016/s0090-3019(00)00267-6.
PubMed 11077095Maniker AH, Vaynman AY, Karimi RJ, Sabit AO, Holland B. Hemorrhagic complications of external ventricular drainage. Neurosurgery. 2006 Oct;59(4 Suppl 2):ONS419-24; discussion ONS424-5. doi: 10.1227/01.NEU.0000222817.99752.E6.
PubMed 17041512
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraventricular Drain Insertion:Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System. A Prospective Randomised Clinical Trial Study.
- ClinicalTrials.gov ID
- NCT01973764
- Acronym / sponsor ID
- In-Vent / 073/13
- Conditions
- Hydrocephalus, Intracranial Hypertension
- Keywords
- Intraoperative ultrasound, Ventricular System, Puncture, Ventricular catheter, Ventriculostomy, Hydrocephalus, Excessive accumulation of cerebrospinal fluids within the cranium. Often associated with dilatation of cerebral ventricles, Intracranial Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to slow recruitment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 1 Nov 2013 (estimated)
- 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.
Puncture of the ventricular system is one of the most frequently performed neurosurgical interventions. This procedure is commonly performed in order to treat and/or measure pathologically elevated intracranial pressure.Therefore a safe and fast surgical procedure is needed. Currently the "landmark-based" placement of intraventricular catheters is the gold standard. However it is known that more than 60% of the catheters are not accurately placed in accordance with "landmark-based" procedures. When the catheter is not placed accurately multiple punctures may be required. In this study, the investigators aim to investigate prospectively whether ultrasound guidance leads to a lower number of incorrect catheter placements, and whether this guidance consequently decreases the number of punctures.
Detailed description
Background
Puncture of the ventricular system is one of the most frequently performed neurosurgical interventions. This procedure is performed in order to treat and/or measure pathologically elevated intracranial pressure. Therefore a safe and fast surgical procedure is needed. Currently the "landmark-based" placement of intraventricular catheters is the gold standard. Nonetheless it is known that more than 60% of the catheters are not placed accurately performing "landmark-based" procedures. When the catheter is not placed accurately multiple punctures may has to be done.
Puncture of the ventricular system is one of the most frequently performed neurosurgical interventions. This procedure is commonly performed in order to treat and/or measure pathologically elevated intracranial pressure. Therefore a safe and fast surgical procedure is needed.Currently the "landmark-based" placement of intraventricular catheters is the gold standard. Nonetheless it is known that more than 60% of the catheters are not placed accurately performing "landmark-based" procedures. When the catheter is not placed accurately multiple punctures may be required. Incorrectly placed intraventricular catheters may lead to undesirable side effects like catheter dysfunction,in which case a correction of the catheter position or a even a new puncture will be required. These corrections increase the risk of intracerebral hemorrhages, infections or secondary brain injuries. In this study, the investigators will prospectively investigate whether ultrasound guidance increases the number of well-placed ventricular catheters and reduces the number of undesirable side effects. In this study the correct catheter position is defined when the catheter tip is located in the lateral ventricle (ipsilateral to the burrhole) anterior of the foramen of Monro. Catheter tip position will be assessed by cranial computer tomography after the operation. The CT scans will be evaluated by an independent expert rater, blinded for the procedure type. These incorrectly placed intraventricular catheters may lead to undesirable side effects, like catheter dysfunction wherefore a correction of the catheter position or a even a new puncture has to be done. These corrections increase the risk of intracerebral hemorrhages, infections or secondary brain damages.
In this study, the investigators will prospectively investigate if ultrasound guidance may raise the number of well placed ventricular catheters and may reduce the number of undesirable side effects. In this study the correct catheter position is defined when the catheter tip is located in the ipsilateral lateral ventricle (to the burrhole) anterior of the foramen of monroi and will be assessed by cranial computer tomography after operation. The CT Scans will be evaluated by an independent expert rater, blinded for the procedure type.
Objective
Aim of the study is to investigate whether ultrasound guidance of ventricular catheter placement leads to a lower number of incorrectly placed catheters and lower number of punctures compared to the landmark-based procedure.
Methods
This study is a prospective randomized controlled clinical trial. A total of 90 patients will be included in the study and randomized in two groups with 45 patients each (ultrasound-guided group and landmark-based group). The position of the ventricular catheter will be assessed using cranial computer tomography (CCT). The CT Scans will be evaluated by two independent expert raters, blinded for the procedure type.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided arm | Other | Procedure: Ultrasound guided ventricular drain insertion |
| Landmark-based arm | Other | Procedure: landmark-based ventricular drain insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >/= 18 years
- Intraventricular catheter insertion or/and intraventricular pressure measurement indicated
- Written informed consent
Key exclusion criteria (3 listed)
- Age < 18 years
- previous ventricular punction < 4 weeks
- bedside puncture indicated
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 |
|---|---|---|
| Ultrasound guided ventricular drain insertionVentricular puncture and insertion of the intraventricular catheter is performed under ultrasound guidance. | Procedure or surgery | Ultrasound guided arm |
| landmark-based ventricular drain insertionVentricular puncture and insertion of the intraventricular catheter is performed without any guiding devices and is based on anatomical landmarks. | Procedure or surgery | Landmark-based arm |
Primary outcome
The correct ventricular catheter position (on post op CT) after single ventricular puncture.
Time frame: 48 h after initial operation
5 secondary outcomes
Number of catheter changes
Time frame: at hospital discharge, expected to be after 10 days
Number of infections
Time frame: at hospital discharge, expected to be after 10 days
Number of days in clinic
Time frame: at hospital discharge, expected to be after 10 days
Number of ventricular punctures
Time frame: "at the end of the operation, expected to be after 1 hour"
Number of patients with intracerebral hemorrhage
Time frame: 24 h after initial operation
Results and safety
The study was stopped early (reason given: Study was stopped due to slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Results publication: PubMed 19934980Toma AK, Camp S, Watkins LD, Grieve J, Kitchen ND. External ventricular drain insertion accuracy: is there a need for change in practice? Neurosurgery. 2009 Dec;65(6):1197-200; discussion 1200-1. doi: 10.1227/01.NEU.0000356973.39913.0B.
- Results publication: PubMed 7057239Sekhar LN, Moossy J, Guthkelch AN. Malfunctioning ventriculoperitoneal shunts. Clinical and pathological features. J Neurosurg. 1982 Mar;56(3):411-6. doi: 10.3171/jns.1982.56.3.0411.
- Results publication: PubMed 8151359Pang D, Grabb PA. Accurate placement of coronal ventricular catheter using stereotactic coordinate-guided free-hand passage. Technical note. J Neurosurg. 1994 Apr;80(4):750-5. doi: 10.3171/jns.1994.80.4.0750.
- Results publication: PubMed 18173315Huyette DR, Turnbow BJ, Kaufman C, Vaslow DF, Whiting BB, Oh MY. Accuracy of the freehand pass technique for ventriculostomy catheter placement: retrospective assessment using computed tomography scans. J Neurosurg. 2008 Jan;108(1):88-91. doi: 10.3171/JNS/2008/108/01/0088.
- Results publication: PubMed 23330995Wilson TJ, Stetler WR Jr, Al-Holou WN, Sullivan SE. Comparison of the accuracy of ventricular catheter placement using freehand placement, ultrasonic guidance, and stereotactic neuronavigation. J Neurosurg. 2013 Jul;119(1):66-70. doi: 10.3171/2012.11.JNS111384. Epub 2013 Jan 18.
- Results publication: PubMed 11077095Strowitzki M, Moringlane JR, Steudel W. Ultrasound-based navigation during intracranial burr hole procedures: experience in a series of 100 cases. Surg Neurol. 2000 Aug;54(2):134-44. doi: 10.1016/s0090-3019(00)00267-6.
- Results publication: PubMed 17041512Maniker AH, Vaynman AY, Karimi RJ, Sabit AO, Holland B. Hemorrhagic complications of external ventricular drainage. Neurosurgery. 2006 Oct;59(4 Suppl 2):ONS419-24; discussion ONS424-5. doi: 10.1227/01.NEU.0000222817.99752.E6.
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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.
Jürgen Beck, MD principal investigator
Dep. of Neurosurgery, University Hospital Bern
Andreas Raabe, MD study director
Dep. of Neurosurgery, University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided ventricular drain insertion and landmark-based ventricular drain insertion in people with Hydrocephalus and Intracranial Hypertension, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 29 Aug 2019. 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 Switzerland. 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?
The study was stopped early (reason given: Study was stopped due to slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correct ventricular catheter position (on post op CT) after single ventricular puncture. (time frame: 48 h after initial operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01973764, which also lists 7 linked publications.
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 29 Aug 2019.