Consciousness DisordersNCT06744114
Etiologies, Definitive Diagnosis and Patient Outcomes in Altered Level of Consciousness in the Emergency Department
An observational study of Consciousness Disorders, run by Superior University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Consciousness Disorders
- What is being tested?
- Consciousness in the Emergency Department
- How many people
- 1 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Definitive Diagnosis and Patient Outcomes in Altered Level of Consciousness in the Emergency Department
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
CMH RAWALAKOT AJK, District poonch , tehsil Rawalakot, AJK PAKISTAN
Kashmir, Punjab Province
About this study
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.
Read the 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
- Conditions
- Consciousness Disorders
- Being tested
- Consciousness in the Emergency Department
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consciousness in the Emergency DepartmentDiagnostic test
To determine the common and definitive etiologies of altered level of consciousness in emergency department.
What is being measured
The primary outcome is the main question the study is designed to answer.
GCS(GLASGOW COMMA SCALE)
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start28 Feb 2024
- Primary completion30 Jun 2024
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consciousness DisordersStudies of the same condition, open and under way.
- More trials run by Superior 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744114
- Sponsor's protocol ID
- MSAHS/Batch-Spring23/017
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiologies, Definitive Diagnosis and Patient Outcomes in Altered Level of Consciousness in the Emergency Department
- ClinicalTrials.gov ID
- NCT06744114
- Acronym / sponsor ID
- MSAHS/Batch-Spring23/017
- Conditions
- Consciousness Disorders
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 20 Dec 2024 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Definitive Diagnosis and Patient Outcomes in Altered Level of Consciousness in the Emergency Department
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Consciousness in the Emergency DepartmentTo determine the common and definitive etiologies of altered level of consciousness in emergency department. | Diagnostic test | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: No
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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 Consciousness Disorders, run by Superior University at 1 site in Pakistan.
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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 20 Dec 2024. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
GCS(GLASGOW COMMA SCALE) (time frame: 12 Months). 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 20 Dec 2024.