Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages

NCT02408757 | Terminated

• 1 other identifier: KEK 077/15
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

As elaborated above only one study reported ultrasonographic changes of the width of the lateral ventricle during clamping of EVD/LD and indicated that ultrasound monitoring might be suitable. No firm data exists about the change of the width of the third ventricle, the diameter of the optic nerve or brain perfusion during clamping of the EVD/LD, although the width of these structures has been shown to depend on intracranial pressure. Ultrasonographic measurements of changes of the width of the third ventricle or the diameter of the optic nerve would have some advantages compared to the ultrasonographic assessments of the lateral ventricles. First, the width of the third ventricle can be measured easier and more reliable than the width of the lateral ventricles (better defined insonation plane and therefore higher repeatability of measurements) 3. Second, whereas assessments of the width of the side and third ventricles with ultrasound depend on the temporal bone windows (10 to 15% of patients have insufficient temporal bone windows), the measurement of the diameter of the optic nerve does not have this limitation and can therefore be performed in almost all patients. Hence, measurement of the diameter of the optic nerve would allow to overcome one major limitation of transcranial ultrasound. The latter limitation for transcranial ultrasound could also be minimized by the use of an ultrasound contrast agent (SonoVue®), but this was also not yet studied. The use of an ultrasound contrast agent would in addition allow to study changes of brain perfusion during clamping of EVD/LD.

Conditions

Hydrocephalus

Keywords

ultrasound; cerebral perfusion; cerebrospinal fluid drainage

Outcome Measures

Primary Outcomes (1)

• binary classification of patients in terms of change of width of cerebrospinal fluid spaces by ultrasound

  24 hours after clamping of EVD/LD

Secondary Outcomes (7)

• change of width of the third ventricle measured with transcranial ultrasound without ultrasound contrast agent

  24 hours after clamping of EVD/LD

• change of width of the third ventricle measured with transcranial ultrasound with ultrasound contrast agent

  24 hours after clamping of EVD/LD

• change of width of the lateral ventricles measured with transcranial ultrasound without ultrasound contrast agent

  24 hours after clamping of EVD/LD

• change of diameter of the optic nerve

  24 hours after clamping of EVD/LD

• change of width of the third ventricle in the CT scan

  24 hours after clamping of EVD/LD

Study Arms (1)

All study participants

The study population consists of consecutive patients undergoing clamping of EVD/LD treated at the Departments of Neurosurgery or Intensive Care Medicine at the University Hospital Bern

Procedure: Sonographic monitoring

Interventions

Sonographic monitoring PROCEDURE

Sonographic monitoring during weaning of cerebrospinal fluid drainage catheters

All study participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of consecutive patients undergoing clamping of EVD/LD treated at the Departments of Neurosurgery or Intensive Care Medicine at the University Hospital Bern

You may qualify if:

• Informed consent of patient or relative and statement of independent physician
• Patient treated with EVD or LD undergoing clamping of EVD/LD
• Age ≥18 ≤ 80 years

You may not qualify if:

• Pregnancy and breastfeeding
• Acute coronary syndromes, severe ischemic heart disease (requiring revascularisation), severe aortic and mitral valve disease, severe congestive heart failure (NYHA \>III/IV)
• Severe pulmonary or renal dysfunction
• Known allergy or adverse reaction to contrast material

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital Bern

Bern, 3010, Switzerland

Location

Related Publications (12)

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• Bolesch S, von Wegner F, Senft C, Lorenz MW. Transcranial ultrasound to detect elevated intracranial pressure: comparison of septum pellucidum undulations and optic nerve sheath diameter. Ultrasound Med Biol. 2015 May;41(5):1233-40. doi: 10.1016/j.ultrasmedbio.2014.12.023. Epub 2015 Jan 28.

  PMID: 25638313 BACKGROUND

• Kiphuth IC, Huttner HB, Struffert T, Schwab S, Kohrmann M. Sonographic monitoring of ventricle enlargement in posthemorrhagic hydrocephalus. Neurology. 2011 Mar 8;76(10):858-62. doi: 10.1212/WNL.0b013e31820f2e0f. Epub 2011 Feb 2.

  PMID: 21288979 BACKGROUND

• Jungehulsing GJ, Brunecker P, Nolte CH, Fiebach JB, Kunze C, Doepp F, Villringer A, Schreiber SJ. Diagnostic transcranial ultrasound perfusion-imaging at 2.5 MHz does not affect the blood-brain barrier. Ultrasound Med Biol. 2008 Jan;34(1):147-50. doi: 10.1016/j.ultrasmedbio.2007.07.006. Epub 2007 Sep 14.

  PMID: 17854981 BACKGROUND

• Engelhardt M, Hansen C, Eyding J, Wilkening W, Brenke C, Krogias C, Scholz M, Harders A, Ermert H, Schmieder K. Feasibility of contrast-enhanced sonography during resection of cerebral tumours: initial results of a prospective study. Ultrasound Med Biol. 2007 Apr;33(4):571-5. doi: 10.1016/j.ultrasmedbio.2006.10.007.

  PMID: 17337111 BACKGROUND

• Kopp R, Zurn W, Weidenhagen R, Meimarakis G, Clevert DA. First experience using intraoperative contrast-enhanced ultrasound during endovascular aneurysm repair for infrarenal aortic aneurysms. J Vasc Surg. 2010 May;51(5):1103-10. doi: 10.1016/j.jvs.2009.12.050.

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  PMID: 20590885 BACKGROUND

• Wu H, Lu Q, Luo Y, He XL, Zeng Y. Application of contrast-enhanced intraoperative ultrasonography in the decision-making about hepatocellular carcinoma operation. World J Gastroenterol. 2010 Jan 28;16(4):508-12. doi: 10.3748/wjg.v16.i4.508.

  PMID: 20101780 BACKGROUND

• Bokor D, Chambers JB, Rees PJ, Mant TG, Luzzani F, Spinazzi A. Clinical safety of SonoVue, a new contrast agent for ultrasound imaging, in healthy volunteers and in patients with chronic obstructive pulmonary disease. Invest Radiol. 2001 Feb;36(2):104-9. doi: 10.1097/00004424-200102000-00006.

  PMID: 11224758 BACKGROUND

• Piscaglia F, Bolondi L; Italian Society for Ultrasound in Medicine and Biology (SIUMB) Study Group on Ultrasound Contrast Agents. The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations. Ultrasound Med Biol. 2006 Sep;32(9):1369-75. doi: 10.1016/j.ultrasmedbio.2006.05.031.

  PMID: 16965977 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus; Cerebrospinal Fluid Leak

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Werner Z'Graggen, MD

  Department of Neurosurgery, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 3, 2015
• Study Start: September 1, 2015
• Primary Completion: October 31, 2023
• Study Completion: November 27, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

CH (1)