PolytraumaNCT06351826
Effectiveness of ELLASI Intervention Towards Polytrauma Patients in the Emergency Department
A study testing ELLASI and Standard in people with Polytrauma, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This clinical trial aims to test the effectiveness of ELLASI intervention in response time, deterioration score, and metabolic status of polytrauma patients in the emergency department. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Polytrauma
- What is being tested?
- ELLASI and Standard
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Jan 2024to May 2024
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Polytrauma patients
- Have not received medical treatment before
Who cannot join
- Canceled registration
- Polytrauma patients who are unwilling to participate in the study
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
RSCM
Jakarta Pusat, West Java, 10430
RSCM, 062211500135, info@rscm.co.id
About this study
Official title: Effectiveness of ELLASI Intervention Towards Response Time, Deterioration, and Metabolic Status of Polytrauma Patients in the Emergency Department
This clinical trial aims to test the effectiveness of ELLASI intervention in response time, deterioration score, and metabolic status of polytrauma patients in the emergency department. The main questions it aims to answer are:
- Is the response time of polytrauma patients who receive ELLASI in the intervention group faster than the control group?
- Is the deterioration score of polytrauma patients who receive ELLASI in the intervention group better than the control group?
- Is the metabolic status of polytrauma patients who receive ELLASI in the intervention group better than the control group?
Read more
Polytrauma patients in the intervention group will receive ELLASI, a structured intervention consisting of the six following:
- Evaluation of airway and cervical control, remove the foreign body, fluid, etc., from the airway,
- Patient positioning and giving oxygen, head-up,
- Stabilisation, including IV insertion, applying pressure and bandage, place monitor, and haemodynamic monitoring
- Assessment: re-assessment of pain and other main complaints
- Make sure informed consents are documented
- Inform patient and family for further intervention
Polytrauma patients in the control group will receive the usual/standard intervention.
Response time, early warning score, and arterial blood gas of polytrauma patients from both groups will be obtained and documented before and after the intervention.
- Conditions
- Polytrauma
- Being tested
- ELLASI, Standard
- Medical subject headings
- Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELLASIOther
A structured intervention for polytrauma patients
StandardOther
Unstructured interventions that are given in everyday practice (standard intervention)
| Study group | Role | What they receive |
|---|---|---|
| ELLASI | Experimental | Polytrauma patients in the intervention group will receive a-6-points structured intervention abbreviated with ELLASI:
1. Evaluasi: Evaluation of airway and cervical control, remove the foreign body, fluid, etc., from the airway
2. Letakkan: patient positioning and give oxygen, head-up.
3. Lakukan: Stabilisasation, including IV insertion, applying pressure and bandage, place monitor, haemodynamic monitoring
4. Assessment: re-assessment of pain and other main complaints
5. Siapkan: make sure informed consents are documented
6. Informasikan: inform patient and family for further intervention Receives: Other: ELLASI |
| Standard | Active comparator | Polytrauma patients in the control group will receive the usual/standard intervention. Receives: Other: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response time
Documented from the beginning of ELLASI and standard interventions are delivered to the ending.
Measured: Immediately before and after the intervention
Deterioration score
Measured with Early Warning Score system used in the hospital where the data was collected. The scores range from 0 to 14. Higher scores mean deterioration
Measured: Immediately before the intervention start and 3 hours after the intervention end
Acidic Level (pH)
Measure pH of arterial blood gas
Measured: Immediately before the intervention start and 3 hours after the intervention end
Base Excess (BE)
Measure BE of arterial blood gas
Measured: Immediately before the intervention start and 3 hours after the intervention end
Bicarbonate level (HCO3)
Measure HCO3 of arterial blood gas
Measured: Immediately before the intervention start and 3 hours after the intervention end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start3 Jan 2024
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolytraumaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siti Nurlaelah, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351826
- Sponsor's protocol ID
- 22070876
- Status last verified
- Apr 2024
- First submitted
- 17 Jan 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be shared with supervisors for consultation. Due to privacy and anonymity, no participants' identifiers that will be disclosed
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of ELLASI Intervention Towards Response Time, Deterioration, and Metabolic Status of Polytrauma Patients in the Emergency Department
- ClinicalTrials.gov ID
- NCT06351826
- Acronym / sponsor ID
- 22070876
- Conditions
- Polytrauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 8 Apr 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.
This clinical trial aims to test the effectiveness of ELLASI intervention in response time, deterioration score, and metabolic status of polytrauma patients in the emergency department. The main questions it aims to answer are:
- Is the response time of polytrauma patients who receive ELLASI in the intervention group faster than the control group?
- Is the deterioration score of polytrauma patients who receive ELLASI in the intervention group better than the control group?
- Is the metabolic status of polytrauma patients who receive ELLASI in the intervention group better than the control group?
Polytrauma patients in the intervention group will receive ELLASI, a structured intervention consisting of the six following:
- Evaluation of airway and cervical control, remove the foreign body, fluid, etc., from the airway,
- Patient positioning and giving oxygen, head-up,
- Stabilisation, including IV insertion, applying pressure and bandage, place monitor, and haemodynamic monitoring
- Assessment: re-assessment of pain and other main complaints
- Make sure informed consents are documented
- Inform patient and family for further intervention
Polytrauma patients in the control group will receive the usual/standard intervention.
Response time, early warning score, and arterial blood gas of polytrauma patients from both groups will be obtained and documented before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELLASI | Experimental | Other: ELLASIPolytrauma patients in the intervention group will receive a-6-points structured intervention abbreviated with ELLASI: 1. Evaluasi: Evaluation of airway and cervical control, remove the foreign body, fluid, etc., from the airway 2. Letakkan: patient positioning and give oxygen, head-up. 3. Lakukan: Stabilisasation, including IV insertion, applying pressure and bandage, place monitor, haemodynamic monitoring 4. Assessment: re-assessment of pain and other main complaints 5. Siapkan: make sure informed consents are documented 6. Informasikan: inform patient and family for further intervention |
| Standard | Active comparator | Other: StandardPolytrauma patients in the control group will receive the usual/standard intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Polytrauma patients
- Have not received medical treatment before
Key exclusion criteria (2 listed)
- Canceled registration
- Polytrauma patients who are unwilling to participate in the 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 |
|---|---|---|
| ELLASIA structured intervention for polytrauma patients | Other | ELLASI |
| StandardUnstructured interventions that are given in everyday practice (standard intervention) | Other | Standard |
Primary outcome
Response time
Time frame: Immediately before and after the intervention
Documented from the beginning of ELLASI and standard interventions are delivered to the ending.
Deterioration score
Time frame: Immediately before the intervention start and 3 hours after the intervention end
Measured with Early Warning Score system used in the hospital where the data was collected. The scores range from 0 to 14. Higher scores mean deterioration
Acidic Level (pH)
Time frame: Immediately before the intervention start and 3 hours after the intervention end
Measure pH of arterial blood gas
Base Excess (BE)
Time frame: Immediately before the intervention start and 3 hours after the intervention end
Measure BE of arterial blood gas
Bicarbonate level (HCO3)
Time frame: Immediately before the intervention start and 3 hours after the intervention end
Measure HCO3 of arterial blood gas
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: No. IPD will only be shared with supervisors for consultation. Due to privacy and anonymity, no participants' identifiers that will be disclosed
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELLASI and Standard in people with Polytrauma, run by Universitas Indonesia at 1 site in Indonesia.
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 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: status not confirmed, as of the sponsor's last update on 8 Apr 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nurlaelah (06281299225207, adeleyla77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response time (time frame: Immediately before and after the intervention). The study lists 5 primary outcomes in all. 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 8 Apr 2024.