Fluid ResponsivenessNCT04092036
Optic Nerve Sheath Diameter in Prediction of Fluid Responsiveness
An observational study of Fluid Responsiveness and Optic Nerve Sheath Diameter, run by Tanta University.
Trial summary
The aim of the study to examine Optic Nerve Sheath Diameter measurement for prediction of fluid responsiveness in hemodynamically unstable patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Responsiveness, Optic Nerve Sheath Diameter, Shock
- What is being tested?
- Optic Nerve Sheath Diameter (ONSD) measurement by ultrasound
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2019to 14 Mar 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Tanta University Hospitals at the surgical intensive care unit
Who may be able to join
- Patients on mechanical ventilation
- 18 years or older
- patients developing hypotension (Mean arterial blood pressure) <65 mmHg
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
- Conditions
- Fluid Responsiveness, Optic Nerve Sheath Diameter, Shock
- Being tested
- Optic Nerve Sheath Diameter (ONSD) measurement by ultrasound
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic Nerve Sheath Diameter (ONSD) measurement by ultrasoundDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Unstable patients | Patients on mechanical ventilation, 18 years or older and developing hypotension (Mean arterial blood pressure) <65 mmHg Receives: Device: Optic Nerve Sheath Diameter (ONSD) measurement by ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cut-off value of optic nerve sheath diameter (ONSD) for prediction of fluid responsiveness
Measured: first day
Secondary outcomes (1)
Correlation between Stroke Volume Variation (by electrical cardiometry) and ONSD
Measured: first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start15 Oct 2019 (estimated)
- Primary completion14 Mar 2020 (estimated)
- Study completion14 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ResponsivenessStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeel Ibraheim Elsagheir, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092036
- Sponsor's protocol ID
- 33157/06/19
- Status last verified
- Sep 2019
- First submitted
- 13 Sep 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study: Optic Nerve Sheath Diameter in Prediction of Fluid Responsiveness
- ClinicalTrials.gov ID
- NCT04092036
- Acronym / sponsor ID
- 33157/06/19
- Conditions
- Fluid Responsiveness, Optic Nerve Sheath Diameter, Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (estimated)
- Primary completion
- 14 Mar 2020 (estimated)
- Study completion
- 14 Mar 2020 (estimated)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study to examine Optic Nerve Sheath Diameter measurement for prediction of fluid responsiveness in hemodynamically unstable patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unstable patients | – | Device: Optic Nerve Sheath Diameter (ONSD) measurement by ultrasoundPatients on mechanical ventilation, 18 years or older and developing hypotension (Mean arterial blood pressure) <65 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Tanta University Hospitals at the surgical intensive care unit
Key inclusion criteria (3 listed)
- Patients on mechanical ventilation
- 18 years or older
- patients developing hypotension (Mean arterial blood pressure) <65 mmHg
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optic Nerve Sheath Diameter (ONSD) measurement by ultrasoundONSD 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). | Device | Unstable patients |
Primary outcome
The cut-off value of optic nerve sheath diameter (ONSD) for prediction of fluid responsiveness
Time frame: first day
1 secondary outcome
Correlation between Stroke Volume Variation (by electrical cardiometry) and ONSD
Time frame: first day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Responsiveness and Optic Nerve Sheath Diameter, run by Tanta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadeel Ibraheim Elsagheir, MBBCH (00201090884208, HadeelElsagheir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cut-off value of optic nerve sheath diameter (ONSD) for prediction of fluid responsiveness (time frame: first day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.