Correlation Intraocular Pressure With Intracranial Pressure

• Conditions: Intraocular Pressure; Trauma, Brain; Children, Only; Intracranial Pressure Increase
• Interventions: Diagnostic Test: with intraocular pressure high; Diagnostic Test: without intraocular pressure high

• Registration Number: NCT03344432
• Lead Sponsor: Hospital Civil de Guadalajara

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.

Study Timeline

• Study Start: 2015-06-10
• Status Verified: 2017-11
• Study First Submitted: 2017-11-12
• Study First Submitted QC: 2017-11-12
• Last Update Submitted: 2017-11-15
• Study First Posted: 2017-11-17
• Last Update Posted: 2017-11-17
• Primary Completion: 2017-11-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Without intraocular pressure high	without intraocular pressure high	Intracranial pressure smaller than 20 mmHg
With intraocular pressure high	with intraocular pressure high	Intracranial pressure equal or more than 20 mmHg
With intraocular pressure high	without intraocular pressure high	Intracranial pressure equal or more than 20 mmHg
Without intraocular pressure high	with intraocular pressure high	Intracranial pressure smaller than 20 mmHg

Primary Outcome Measures

Name	Time	Method
Intraocular pressure smaller than 20 mmHg	Immediately	Abscence of increased intraocular pressure (smaller than 20 mmHg) without intracranial pressure smaller than 20 mmHg.

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure equal or more than 20 mmHg	Immediately	Intraocular pressure equal or more than 20 mmHg with Intracranial pressure equal or more than 20 mmHg

Trial Locations

Locations (1)

Hospital Civil Fray Antonio Alcalde; 🇲🇽 Guadalajara, Jalisco, Mexico