CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
Ultrasoundother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03757312
NCT03757312N/ACompleted

A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass

Marco Corridore·interventional·Posted Nov 28, 2018·Updated Sep 13, 2021

In Brief

A clinical study evaluating Ultrasound for Congenital Heart Disease and Congenital Heart Defect. Completed, enrolled 14 participants across 1 site.

Detailed Summary

The purpose of the proposed study is to evaluate the incidence of subtle increases in intracranial pressure (ICP) following cardiopulmonary bypass (CPB) using optic nerve sheath diameter (ONSD), measured by non-invasive ultrasound. As direct measurements of ICP are not feasible following CPB, ONSD will be used as a correlate of ICP. ONSD has been shown to be effective in the ICU and emergency room setting for detecting increased ICP and is an accepted standard for such measurements. The primary hypothesis is that changes in ICP occur following CPB without clinically appreciable signs and symptoms. These changes in ICP will be reflected by changes in ONSD. If there is a significant incidence of sub-clinical cerebral edema and increased ICP postoperatively, these findings may impact postoperative hemodynamic and ventilation goals and techniques.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 28, 2018
Enrollment StartApr 24, 2019
Primary CompletionJan 16, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.6 years ago

Interventions

Ultrasoundother

Ocular ultrasound to measure optic nerve sheath diameter (ONSD).