NCT04834453

Brief 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. Transcranial Doppler sonography provides noninvasive evaluation of intracranial pressure by its characteristic wave patterns

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

April 28, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2021

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

April 4, 2021

Last Update Submit

July 20, 2022

Conditions

Brain Edema

Outcome Measures

Primary Outcomes (1)

  • the correlation between CCT scans score and Pulsatility Index of each patient

    7 days

Interventions

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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

You may qualify if:

  • isolated blunt Traumatic Brain Injury
  • age 18-60 years

You may not qualify if:

  • Pregnancy
  • Intracerebral hemorrhage
  • Patients whose blood flow velocities could not be obtained from Trans temporal acoustic bone windows.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 37091450DERIVED

MeSH Terms

Conditions

Brain Edema

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 4, 2021

First Posted

April 8, 2021

Study Start

April 28, 2021

Primary Completion

November 10, 2021

Study Completion

December 28, 2021

Last Updated

July 21, 2022

Record last verified: 2022-07

Locations

EG(1)