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RecruitingNCT06351826Updated Apr 8, 2024

Effectiveness of ELLASI Intervention Towards Polytrauma Patients in the Emergency Department

An interventional study of ELLASI and Standard in Polytrauma, sponsored by Indonesia University. Recruiting at 1 site in Indonesia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-08.

Sponsored by Indonesia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. Is the response time of polytrauma patients who receive ELLASI in the intervention group faster than the control group?
  2. Is the deterioration score of polytrauma patients who receive ELLASI in the intervention group better than the control group?
  3. 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:

  1. Evaluation of airway and cervical control, remove the foreign body, fluid, etc., from the airway,
  2. Patient positioning and giving oxygen, head-up,
  3. Stabilisation, including IV insertion, applying pressure and bandage, place monitor, and haemodynamic monitoring
  4. Assessment: re-assessment of pain and other main complaints
  5. Make sure informed consents are documented
  6. 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.

02

Conditions studied

  • Polytrauma

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03

In context

Multiple Trauma

139 studies on the registry are indexed under Multiple Trauma; 32 are open to participants now.

This study's planned enrollment of 48 is below the median of 94 across 50 interventional studies indexed under Multiple Trauma.

Browse Multiple Trauma studies →

Lead sponsor

Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Polytrauma patients
  • Have not received medical treatment before

Exclusion criteria

Exclusion Criteria:

  • Canceled registration
  • Polytrauma patients who are unwilling to participate in the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    ELLASI

    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

    Other: ELLASI

  • Active comparator
    Standard

    Polytrauma patients in the control group will receive the usual/standard intervention.

    Other: Standard

Interventions

  • OtherELLASI

    A structured intervention for polytrauma patients

  • OtherStandard

    Unstructured interventions that are given in everyday practice (standard intervention)

06

What researchers measure

Primary outcomes

  1. Response time

    Documented from the beginning of ELLASI and standard interventions are delivered to the ending.

    Time frame: Immediately before and after the intervention

  2. 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

    Time frame: Immediately before the intervention start and 3 hours after the intervention end

  3. Acidic Level (pH)

    Measure pH of arterial blood gas

    Time frame: Immediately before the intervention start and 3 hours after the intervention end

  4. Base Excess (BE)

    Measure BE of arterial blood gas

    Time frame: Immediately before the intervention start and 3 hours after the intervention end

  5. Bicarbonate level (HCO3)

    Measure HCO3 of arterial blood gas

    Time frame: Immediately before the intervention start and 3 hours after the intervention end

07

Study locations

1 of 1 sites recruiting
  • RSCM
    Jakarta Pusat, Jawa Barat 10430, Indonesia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — IPD will only be shared with supervisors for consultation. Due to privacy and anonymity, no participants' identifiers that will be disclosed

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06351826
Responsible party
Siti Nurlaelah (Effectiveness of ELLASI Intervention Towards Response Time, Deterioration, and Metabolic Status of Polytrauma Patients in the Emergency Department, Indonesia University) — Principal investigator
First posted
Apr 8, 2024
Start date
Jan 3, 2024
Primary completion
Apr 2024 (estimated)
Completion
May 2024 (estimated)
Last update
Apr 8, 2024

Study contacts

Nurlaelah
Contact
adeleyla77@gmail.com
06281299225207

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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