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Correlation Intraocular Pressure With Intracranial Pressure (IOPICPTBI)

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ClinicalTrials.gov Identifier: NCT03344432
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
KARLA ISIS AVILES MARTINEZ, 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.


Condition or disease Intervention/treatment
Intraocular Pressure Intracranial Pressure Increase Trauma, Brain Children, Only 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 [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Correlation of Intraocular Pressure With Intracranial Pressure in Childs With Severe Trauma Brain Injury
Actual Study Start Date : June 10, 2015
Estimated Primary Completion Date : November 30, 2017
Estimated Study Completion Date : December 31, 2019

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.




Primary Outcome Measures :
  1. Intraocular pressure smaller than 20 mmHg [ Time Frame: Immediately ]
    Abscence of increased intraocular pressure (smaller than 20 mmHg) without intracranial pressure smaller than 20 mmHg.


Secondary Outcome Measures :
  1. Intraocular pressure equal or more than 20 mmHg [ Time Frame: Immediately ]
    Intraocular pressure equal or more than 20 mmHg with Intracranial pressure equal or more than 20 mmHg



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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344432


Contacts
Contact: Karla Isis I Aviles-Martinez, PhD 39424400 ext 48052 draisispediatra@yahoo.com.mx
Contact: Adriana López-Enríquez, MD 39424400 ext 48051 aleurg2@hotmail.com

Locations
Mexico
Hospital Civil Fray Antonio Alcalde Recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: Karla Isis Aviles-Martinez, PhD    39424400    draisispediatra@yahoo.com.mx   
Contact: Juan Luis Soto-Mancilla, Master    39424400      
Sponsors and Collaborators
Hospital Civil de Guadalajara
Investigators
Principal Investigator: Karla Isis I Aviles Martinez, PhD Hospital Civil Fray Antonio Alcalde

Responsible Party: KARLA ISIS AVILES MARTINEZ, Dra. Karla Isis Avilés-Martínez, Hospital Civil de Guadalajara
ClinicalTrials.gov Identifier: NCT03344432     History of Changes
Other Study ID Numbers: HCG/CI-0693/15
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Intracranial Hypertension
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Injuries
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries