Intracranial Hypertension Clinical Trial
Official title:
Optic Nerve Sheath Diameter in Retrobulbar Ultrasound as a Surrogate Measure for Intracranial Pressure Before and After Non-invasive Strategies
NCT number | NCT03634176 |
Other study ID # | ABAY |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2017 |
Est. completion date | September 30, 2018 |
Verified date | November 2018 |
Source | Hospital Dr. Miguel Pérez Carreño |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Measurement of the diameter of the sheath of the optic nerve in patients hospitalized in
intensive care, with increased intracranial pressure (> 20mmHg) as a substitute measure for
diagnosis and follow-up before and after different non-invasive strategies.
Three groups were created in which, through strategies already proven and non-invasive
(mannitol, hypertonic solution 7.5% NaCl, reverse trendelenburg) to decrease the intracranial
pressure, the optic nerve diameter measurement was performed and simultaneously the
investigators monitored intracranial pressure through an intraventricular catheter
continuously to determine if both correspond
Status | Completed |
Enrollment | 90 |
Est. completion date | September 30, 2018 |
Est. primary completion date | August 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Adult patients (= 18 years old) with traumatic or non-traumatic elevated ICP (defined as greater than 20 mm Hg for at least 10min) - Hospitalized in ICU - Patients with ICP continuous measurement through an intraventricular catheter - Respiratory rate maintained at 10-18 breaths/min to maintain the end tidal carbon dioxide partial pressure between 35 and 40 mmHg - Peak airway pressure <35 cmH2O - Positive end-expiratory pressure <5 cmH2O Exclusion Criteria: - Patients who had undergone cranial decompression surgery - Patients with ocular pathology - Patients who had previously undergone eye surgery |
Country | Name | City | State |
---|---|---|---|
Venezuela | Hospital Dr Miguel Perez Carreño | Caracas | Venezuela, Bolivarian Republic Of |
Lead Sponsor | Collaborator |
---|---|
Hospital Dr. Miguel Pérez Carreño |
Venezuela,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Optic nerve sheet diameter | The optic nerve sheet diameter in each eye was measured vertically and horizontally 3 mm behind the optic disc, with the two values averaged | immediately before administering the treatment according to the group and every 30 minutes after administering the treatment until 90 min. |
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