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Correlation Intraocular Pressure With Intracranial Pressure (IOPICPTBI)

H

Hospital Civil de Guadalajara

Status

Unknown

Conditions

Intracranial Pressure Increase
Children, Only
Intraocular Pressure
Trauma, Brain

Treatments

Diagnostic Test: without intraocular pressure high
Diagnostic Test: with intraocular pressure high

Study type

Observational

Funder types

Other

Identifiers

NCT03344432
HCG/CI-0693/15

Details and patient eligibility

About

Severe Trauma Brain Injury (TBIs) is a public health problem and monitoring of Intracranial Pressure (ICP) is a determinant key of it prognosis. Within the noninvasive methods to estimate the ICP, the measurement of intraocular pressure has been proposed because of its biological plausibility (proximity of the eye to the encephalic contend).

Objective. Correlate intraocular pressure with ICP in children with TBIs and obtain their utility values.

Full description

Severe Trauma Brain Injury (TBIs) is a public health problem and monitoring of Intracranial Pressure (ICP) is a determinant key of it prognosis. Within the noninvasive methods to estimate the ICP, the measurement of intraocular pressure has been proposed because of its biological plausibility (proximity of the eye to the encephalic contend).

Objective. Correlate intraocular pressure with ICP in children with TBIs and obtain their utility values.

Material and methods. Correlation and diagnostic test design study. Inclusion criteria: children with TBIs admitted to the emergency room and indication of catheter for ICP measurement.

Exclusion criteria: injury or ophthalmic disease, glaucoma, encephalic death. Intraocular pressure was measured with electronic tonometer in both eyes prior to placement of the catheter for ICP measurement.

Correlation was estimated with Spearman's Rho. The utility values of the diagnostic test were obtained from an Receiver Operating Characteristic curve.

Enrollment

30 estimated patients

Sex

All

Ages

2 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Children with severe trauma brain injury (Coma Glasgow Scale smaller than 9 points),
  2. who have been admitted to the pediatric emergency room
  3. and in whom the treating neurosurgeon has decided to place a catheter for intracranial pressure measurement.

Exclusion criteria

  1. Ocular trauma,
  2. brain death,
  3. know eye disease,
  4. refusal of parents or guardians to participate in the study.

Trial design

30 participants in 2 patient groups

With intraocular pressure high
Description:
Intracranial pressure equal or more than 20 mmHg
Treatment:
Diagnostic Test: without intraocular pressure high
Diagnostic Test: with intraocular pressure high
Without intraocular pressure high
Description:
Intracranial pressure smaller than 20 mmHg
Treatment:
Diagnostic Test: without intraocular pressure high
Diagnostic Test: with intraocular pressure high

Trial contacts and locations

1

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Central trial contact

Adriana López-Enríquez, MD; Karla Isis I Aviles-Martinez, PhD

Data sourced from clinicaltrials.gov

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