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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2018
Source Hospital Dr. Miguel Pérez Carreño
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
optical nerve sheet diameter
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).

Locations

Country Name City State
Venezuela Hospital Dr Miguel Perez Carreño Caracas Venezuela, Bolivarian Republic Of

Sponsors (1)

Lead Sponsor Collaborator
Hospital Dr. Miguel Pérez Carreño

Country where clinical trial is conducted

Venezuela, 

Outcome

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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