Optic Nerve Sheath Diameter in Prediction of Fluid Responsiveness

Prospective Study: Optic Nerve Sheath Diameter in Prediction of Fluid Responsiveness

The aim of the study to examine Optic Nerve Sheath Diameter measurement for prediction of fluid responsiveness in hemodynamically unstable patients

Study Overview

• Status: Unknown
• Conditions: Shock; Optic Nerve Sheath Diameter; Fluid Responsiveness
• Intervention / Treatment: Device: Optic Nerve Sheath Diameter (ONSD) measurement by ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

• Study Contact: Name: Hadeel Ibraheim Elsagheir, MBBCH; Phone Number: 00201090884208; Email: HadeelElsagheir@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Tanta University Hospitals at the surgical intensive care unit

Description

Inclusion Criteria:

• Patients on mechanical ventilation
• 18 years or older
• patients developing hypotension (Mean arterial blood pressure) <65 mmHg

Exclusion Criteria:

• Patients with Spontaneously breathing activity.
• Patients with a history of intracranial disease e.g. (stroke, TBI, causes of increased intracranial pressure).
• local cause in the eye as (Glaucoma, Single eye)
• Need for high PEEP.
• Known history of cardiac disease.
• Organ/s failure at admission

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Unstable patients; Patients on mechanical ventilation, 18 years or older and developing hypotension (Mean arterial blood pressure) <65 mmHg

Device: Optic Nerve Sheath Diameter (ONSD) measurement by ultrasound; ONSD measurements will be performed in the supine patient. Ultrasound gel will be applied over the closed upper eyelid. The ultrasound probe will be placed on the temporal area of the eyelid. Then the probe will be angled in order to display the entry of the optic nerve into the globe. ONSD will be measured 3 mm behind the globe in the transverse plane perpendicular to the optic nerve. For each optic nerve three measurements will be made. The ONSD corresponds to the mean of the six values which will be obtained from each patient (three measurements for each eye).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The cut-off value of optic nerve sheath diameter (ONSD) for prediction of fluid responsiveness	first day

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation between Stroke Volume Variation (by electrical cardiometry) and ONSD	first day

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 15, 2019
• Primary Completion (ANTICIPATED): March 14, 2020
• Study Completion (ANTICIPATED): March 14, 2020

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 14, 2019
• First Posted (ACTUAL): September 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 14, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 33157/06/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No