Correlation Intraocular Pressure With Intracranial Pressure (IOPICPTBI)

Correlation of Intraocular Pressure With Intracranial Pressure in Childs With Severe Trauma Brain Injury

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.

Study Overview

• Status: Unknown
• Conditions: Intraocular Pressure; Intracranial Pressure Increase; Children, Only; Trauma, Brain
• Intervention / Treatment: Diagnostic test: with intraocular pressure high; Diagnostic test: without intraocular pressure high

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Recruiting
      • Hospital Civil Fray Antonio Alcalde
      • Contact: Karla Isis Aviles-Martinez, PhD; Phone Number: 39424400; Email: draisispediatra@yahoo.com.mx
      • Contact: Juan Luis Soto-Mancilla, Master; Phone Number: 39424400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
With intraocular pressure high; Intracranial pressure equal or more than 20 mmHg	Diagnostic test: with intraocular pressure high; Measurement of intraocular pressure The measurement will be made with a electronic minimum contact tonometer for measuring intraocular pressure immediately before the placement of the invasive catheter for measurement of intracranial pressure.; Diagnostic test: without intraocular pressure high; Measurement of intraocular pressure The measurement will be made with a electronic minimum contact tonometer for measuring intraocular pressure immediately before the placement of the invasive catheter for measurement of intracranial pressure.
Without intraocular pressure high; Intracranial pressure smaller than 20 mmHg	Diagnostic test: with intraocular pressure high; Measurement of intraocular pressure The measurement will be made with a electronic minimum contact tonometer for measuring intraocular pressure immediately before the placement of the invasive catheter for measurement of intracranial pressure.; Diagnostic test: without intraocular pressure high; Measurement of intraocular pressure The measurement will be made with a electronic minimum contact tonometer for measuring intraocular pressure immediately before the placement of the invasive catheter for measurement of intracranial pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure smaller than 20 mmHg	Abscence of increased intraocular pressure (smaller than 20 mmHg) without intracranial pressure smaller than 20 mmHg.	Immediately

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure equal or more than 20 mmHg	Intraocular pressure equal or more than 20 mmHg with Intracranial pressure equal or more than 20 mmHg	Immediately

Collaborators and Investigators

• Sponsor: Hospital Civil de Guadalajara
• Investigators: Principal Investigator: Karla Isis I Aviles Martinez, PhD, Hospital Civil Fray Antonio Alcalde

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2015
• Primary Completion (Anticipated): November 30, 2017
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 12, 2017
• First Submitted That Met QC Criteria: November 12, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 15, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Intracranial Hypertension
• Other Study ID Numbers: HCG/CI-0693/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No