Optic Nerve Sheath Diameter in Prediction of Fluid Responsiveness

NCT04092036 | Unknown

• 1 other identifier: 33157/06/19
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Fluid Responsiveness; Optic Nerve Sheath Diameter; Shock

Outcome Measures

Primary Outcomes (1)

• The cut-off value of optic nerve sheath diameter (ONSD) for prediction of fluid responsiveness

  first day

Secondary Outcomes (1)

• Correlation between Stroke Volume Variation (by electrical cardiometry) and ONSD

  first day

Study Arms (1)

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

Interventions

Optic Nerve Sheath Diameter (ONSD) measurement by ultrasound DEVICE

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).

Unstable patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tanta University Hospitals at the surgical intensive care unit

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hadeel Ibraheim Elsagheir, MBBCH

CONTACT

00201090884208; HadeelElsagheir@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Anesthesiology, Surgical ICU and Pain Medicine Department

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: October 15, 2019
• Primary Completion: March 14, 2020
• Study Completion: March 14, 2020
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share