- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06744114
Etiologies, Definitive Diagnosis and Patient Outcomes in Altered Level of Consciousness in the Emergency Department
December 19, 2024 updated by: Muhammad Naveed Babur, Superior University
When someone starts acting differently in terms of how alert or awake they are, it can be a tough situation for emergency (ER) department doctors.e
exact and definitive etiologies of ALOC that can be intracranial or extracranial.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The change in terms of mental state in accordance with how alert and awake patient is termed as altered level of consciousness.
Etiologies will be classified by using convenience sampling.
GCS<14 patients will be included in this study.
Data will be collected through a slight modification in a pre-designed Performa.
Reference point for the data collection will be the time of discharge from the emergency department.
In Previous studies mostly, etiologies were classified as extracranial and intracranial.
Some studies found neurological etiologies most dominant as an extra cranial and some studies found systematic infections ,metabolic causes and some demonstrated that intracranial etiologies were dominant.
So, in this study we will find the definitive diagnosis in patient having ALOC which can be intracranial or extracranial.
And also, it will be compared with GCS scale.
This study will identify th
Study Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Punjab
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Kashmir, Punjab, Pakistan
- CMH RAWALAKOT AJK, District poonch , tehsil Rawalakot, AJK PAKISTAN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Definitive Diagnosis and Patient Outcomes in Altered Level of Consciousness in the Emergency Department
Description
Inclusion Criteria:
- Patients with GCS<15, age group 18 years to 90 years which come in emergency department due to any etiology will be included in this study.
Exclusion Criteria:
- GCS = 15 will be excluded from the study.
- patients coming in any outpatient department setting or other than emergency department and age group <18 or > 90 will be excluded from this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
GCS(GLASGOW COMMA SCALE)
Time Frame: 12 Months
|
The GCS is scored between 3 and 15, 3 being the worst and 15 the best.
It is composed of three parameters: best eye response (E), best verbal response (V), and best motor response (M).
The components of the GCS should be recorded individually.
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2024
Primary Completion (Actual)
June 30, 2024
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
December 17, 2024
First Submitted That Met QC Criteria
December 19, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 19, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSAHS/Batch-Spring23/017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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