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Determining the relationship between duration of external ventricular drain (EVD) requirement and attributable complication and catheter length from burr hole to the skin exit point

A randomized, three-arm, double-blind, parallel control, single-center clinical trial to determine the relationship between duration of external ventricular drain (EVD) requirement and attributable complications and catheter length from burr hole to skin exit point

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160430027680N2
Enrollment
108
Registered
2020-02-26
Start date
2013-05-11
Completion date
Unknown
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrocephalus. Obstructive hydrocephalus

Interventions

Intervention 1: Control group: EVD length = 5 cm
this is the control group and has a subcutaneous catheter length of 5 cm as the conventional method of EVD placement. Intervention 2: Intervention group: Intervention group 1: EVD length = 10 cm
this group is the same as the control group and similar surgery method is used but with EVD tunnel 5 cm more length. Intervention 3: Intervention group: Intervention group 2: EVD length = 15 cm
this group follows the same protocol as other intervention group but with an extra 5 cm catheter length.

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Age under 18 years Temporary hydrocephalus Absence of active primary CNS infection at randomization

Exclusion criteria

Exclusion criteria: Active CNS infection at randomization Previous EVD within past week Shunt infection Immunodeficiency

Design outcomes

Primary

MeasureTime frame
Length of time required for EVD being in place (duration until patients are EVD-free). Timepoint: Daily. Method of measurement: Days until patients are EVD-free. Need for EVD is assessed with physicians judgment based on level of consciousness, CSF pressure, and CSF infections.

Secondary

MeasureTime frame
Cerebrospinal fluid (CSF) infection. Timepoint: Daily. Method of measurement: Patients temperatures were recorded daily. If febrile and no other evidence of infections, patient was assessed for the CSF infection both clinically (other vital signs, consciousness and delirium, physicals related to meningitis) and para-clinical evaluations (labs and cultures).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSara Hanaei

Tehran University of Medical Sciences

sara.hanaei@gmail.com+98 939 898 9291

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 15, 2026