Correlation Intraocular Pressure With Intracranial Pressure

Children, Only Clinical Trial

— IOPICPTBI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03344432
• Other study ID #: HCG/CI-0693/15
• Status: Recruiting
• Phase: N/A
• First received: November 12, 2017
• Last updated: November 15, 2017
• Start date: June 10, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2017
• Source: Hospital Civil de Guadalajara
• Contact: Karla Isis I Aviles-Martinez, PhD
• Phone: 39424400
• Email: draisispediatra[@]yahoo.com.mx
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries, Traumatic
• Children, Only
• Intracranial Hypertension
• Intracranial Pressure Increase
• Intraocular Pressure
• Trauma, Brain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Mexico	Hospital Civil Fray Antonio Alcalde	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Civil de Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure smaller than 20 mmHg	Abscence of increased intraocular pressure (smaller than 20 mmHg) without intracranial pressure smaller than 20 mmHg.	Immediately
Secondary	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