Sponsor study identifier
observational
90
1 country
1
Study Start
February 1, 2017
Actual (reported)Primary Completion
August 30, 2018
Actual (reported)Study Completion
September 30, 2018
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2017
Actual (reported)August 11, 2018
Actual (reported)August 16, 2018
Actual (reported)August 30, 2018
Actual (reported)September 30, 2018
Actual (reported)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.
both optic nerve sheath diameter (the posterior 3mm of the papilla) before and after received 0.5gr/kg 20% mannitol
both optic nerve sheath diameter (the posterior 3mm of the papilla) before and after received 1.5 ml/kg 7.5% NaCl solution
both optic nerve sheath diameter (the posterior 3mm of the papilla) before and after patients were positioned on reverse Trendelenburg position 30 degrees higher than the feet
The ONSD in each eye was measured vertically and horizontally 3 mm behind the optic disc, with the two values averaged. No pressure was applied to the orbit. At each time point, measurements were taken within 5 min. The measurements were made before (T1) and after some of the strategies according to group 30 min (T2), 60 min (T3), and 90 min (T4).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients hospitalized in the intensive care unit of the Dr. Migel Pérez Carreño hospital with increased intracranial pressure of traumatic or non-traumatic etiology.
Hospital Dr Miguel Perez Carreño
Caracas, Venezuela, Bolivarian Republic of, 1020, Venezuela
90 participants (actual enrollment reported by the registry).
First Submitted
August 11, 2018
First Posted
August 16, 2018
Study Start
February 1, 2017
Actual (reported)Optic Nerve Sheath Diameter in Craniosynostosis
Contact the study team to confirm eligibility.
Primary Completion
August 30, 2018
Actual (reported)Study Completion
September 30, 2018
Actual (reported)Last Updated
November 8, 2018
Record last verified: 2018-11
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Source: ClinicalTrials.gov.
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