Optic Nerve Sheath Diameter in Prediction of Fluid Responsiveness

Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04092036
• Other study ID #: 33157/06/19
• Status: Not yet recruiting
• Start date: October 15, 2019
• Est. completion date: March 14, 2020

Study information

• Verified date: September 2019
• Source: Tanta University
• Contact: Hadeel Ibraheim Elsagheir, MBBCH
• Phone: 00201090884208
• Email: HadeelElsagheir[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: March 14, 2020
• Est. primary completion date: March 14, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fluid Responsiveness
• Optic Nerve Sheath Diameter
• Shock

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cut-off value of optic nerve sheath diameter (ONSD) for prediction of fluid responsiveness		first day
Secondary	Correlation between Stroke Volume Variation (by electrical cardiometry) and ONSD		first day