Optic Nerve Sheath Diameter in Retrobulbar Ultrasound as a Surrogate Measure for Intracranial Pressure Before and After Non-invasive Strategies

NCT ID: NCT03634176

Last Updated: 2018-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intracranial Hypertension Optic Nerve Sheath Diameter

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group M

both optic nerve sheath diameter (the posterior 3mm of the papilla) before and after received 0.5gr/kg 20% mannitol

optical nerve sheet diameter

Intervention Type DIAGNOSTIC_TEST

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).

Group H

both optic nerve sheath diameter (the posterior 3mm of the papilla) before and after received 1.5 ml/kg 7.5% NaCl solution

optical nerve sheet diameter

Intervention Type DIAGNOSTIC_TEST

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).

Group P

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

optical nerve sheet diameter

Intervention Type DIAGNOSTIC_TEST

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Dr. Miguel Pérez Carreño

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aldo Saad Diab

Principal Investigator, anesthesiologist.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Dr Miguel Perez Carreño

Caracas, Venezuela, Bolivarian Republic of, Venezuela

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Venezuela

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ABAY

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Optic Nerve Compliance Study
NCT00328835 COMPLETED NA
Pars Plana Ex-Press Shunt in Vitrectomized Eyes
NCT03605823 UNKNOWN PHASE1/PHASE2
Isometric Exercise in NTG
NCT03921372 COMPLETED NA
Eye Pressure Lowering Surgery
NCT01931904 RECRUITING