Brain EdemaNCT04834453
Correlation of Trans Cranial Doppler Ultrasound and CT Scan in Monitoring of Posttraumatic Brain Edema
An observational study of Brain Edema, run by Ain Shams University at 1 site in Egypt.
Trial summary
The most common tool for diagnosis and follow up of cerebral edema in ICU is brain CT scan that necessitate patient transportation with risk of hemodynamic instability, and exposure to radiation. Transcranial Doppler (TCD) sonography allows true and rapid imaging of blood flow velocities of intracranial vessels. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Brain Edema
- What is being tested?
- transcranial ultrasound
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Apr 2021to 28 Dec 2021
- 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 to 60 years
- All sexes
- Adult
Study population: Patients with isolated blunt TBI from (age 18-60 years) of both sex, will be included in the study and followed prospectively. Severity of trauma is evaluated by GCS, Rotterdam computed tomography score (CTS) care system with the help of our radiodiagnosis colleagues
Who may be able to join
- isolated blunt Traumatic Brain Injury
- age 18-60 years
Who cannot join
- Pregnancy
- Intracerebral hemorrhage
- Patients whose blood flow velocities could not be obtained from Trans temporal acoustic bone windows.
Trial locations and contacts
1 site in 1 country.
About this study
The most common tool for diagnosis and follow up of cerebral edema in ICU is brain CT scan that necessitate patient transportation with risk of hemodynamic instability, and exposure to radiation.
Transcranial Doppler (TCD) sonography allows true and rapid imaging of blood flow velocities of intracranial vessels. Transcranial Doppler sonography provides noninvasive evaluation of intracranial pressure by its characteristic wave patterns
- Conditions
- Brain Edema
- Being tested
- transcranial ultrasound
- Medical subject headings
- Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial ultrasoundDiagnostic test
- Transcranial Doppler sonography will be performed with the patients in the supine position., using low frequency probe of 2 MHz will be placed on temporal bone- will be performed daily
What is being measured
The primary outcome is the main question the study is designed to answer.
the correlation between CCT scans score and Pulsatility Index of each patient
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start28 Apr 2021
- Primary completion10 Nov 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain EdemaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Ammar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834453
- Sponsor's protocol ID
- R 75/2021
- Status last verified
- Jul 2022
- First submitted
- 4 Apr 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ammar MA, Abdelmoneim W, Abdalla W. Correlation of transcranial Doppler based parameters with computed tomography assessed cerebral oedema score in patients with traumatic brain injury: A prospective observational study. Indian J Anaesth. 2023 Feb;67(2):180-185. doi: 10.4103/ija.ija_337_22. Epub 2023 Feb 16.
PubMed 37091450
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Trans Cranial Doppler Ultrasound and CT Scan in Monitoring of Posttraumatic Brain Edema
- ClinicalTrials.gov ID
- NCT04834453
- Acronym / sponsor ID
- R 75/2021
- Conditions
- Brain Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 8 Apr 2021 (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 most common tool for diagnosis and follow up of cerebral edema in ICU is brain CT scan that necessitate patient transportation with risk of hemodynamic instability, and exposure to radiation.
Transcranial Doppler (TCD) sonography allows true and rapid imaging of blood flow velocities of intracranial vessels. Transcranial Doppler sonography provides noninvasive evaluation of intracranial pressure by its characteristic wave patterns
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients with isolated blunt TBI from (age 18-60 years) of both sex, will be included in the study and followed prospectively. Severity of trauma is evaluated by GCS, Rotterdam computed tomography score (CTS) care system with the help of our radiodiagnosis colleagues
Key inclusion criteria (2 listed)
- isolated blunt Traumatic Brain Injury
- age 18-60 years
Key exclusion criteria (3 listed)
- Pregnancy
- Intracerebral hemorrhage
- Patients whose blood flow velocities could not be obtained from Trans temporal acoustic bone windows.
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 |
|---|---|---|
| transcranial ultrasound- Transcranial Doppler sonography will be performed with the patients in the supine position., using low frequency probe of 2 MHz will be placed on temporal bone- will be performed daily | Diagnostic test | – |
Primary outcome
the correlation between CCT scans score and Pulsatility Index of each patient
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Derived from this study: PubMed 37091450Ammar MA, Abdelmoneim W, Abdalla W. Correlation of transcranial Doppler based parameters with computed tomography assessed cerebral oedema score in patients with traumatic brain injury: A prospective observational study. Indian J Anaesth. 2023 Feb;67(2):180-185. doi: 10.4103/ija.ija_337_22. Epub 2023 Feb 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Edema, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the correlation between CCT scans score and Pulsatility Index of each patient (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04834453, which also lists 1 linked publication.
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 21 Jul 2022.