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Optic Nerve Sheath Diameter in Prediction of Fluid Responsiveness

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ClinicalTrials.gov Identifier: NCT04092036
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Hadeel Ibraheim Elsagheir, Tanta University

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

Condition or disease Intervention/treatment
Fluid Responsiveness Optic Nerve Sheath Diameter Shock Device: Optic Nerve Sheath Diameter (ONSD) measurement by ultrasound

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Prospective Study: Optic Nerve Sheath Diameter in Prediction of Fluid Responsiveness
Estimated Study Start Date : October 15, 2019
Estimated Primary Completion Date : March 14, 2020
Estimated Study Completion Date : March 14, 2020

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).





Primary Outcome Measures :
  1. The cut-off value of optic nerve sheath diameter (ONSD) for prediction of fluid responsiveness [ Time Frame: first day ]

Secondary Outcome Measures :
  1. Correlation between Stroke Volume Variation (by electrical cardiometry) and ONSD [ Time Frame: first day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Tanta University Hospitals at the surgical intensive care unit
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092036


Contacts
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Contact: Hadeel Ibraheim Elsagheir, MBBCH 00201090884208 HadeelElsagheir@gmail.com

Sponsors and Collaborators
Tanta University

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Responsible Party: Hadeel Ibraheim Elsagheir, Resident at Anesthesiology, Surgical ICU and Pain Medicine Department, Tanta University
ClinicalTrials.gov Identifier: NCT04092036     History of Changes
Other Study ID Numbers: 33157/06/19
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No