Clinical trial NCT03344432: Correlation Intraocular Pressure With Intracranial Pressure
Official title: Correlation of Intraocular Pressure With Intracranial Pressure in Childs With Severe Trauma Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intraocular Pressure
Intracranial Pressure Increase
Trauma, Brain
Children, Only
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children of 2 at 15 years old with severe trauma brain injury (Coma Glasgow Scale smaller than 9 points), in pediatric emergency room, with indication by the neurosurgeon to place a invasive catheter for intracranial pressure measurement.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraocular pressure smaller than 20 mmHg
timeFrame: Immediately
Secondary outcomes:
measure: Intraocular pressure equal or more than 20 mmHg
timeFrame: Immediately
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde
state: Jalisco
Study officials:
affiliation: Hospital Civil Fray Antonio Alcalde
name: Karla Isis I Aviles Martinez, PhD
role: PRINCIPAL_INVESTIGATOR
References: