Effectiveness of ELLASI Intervention Towards Polytrauma Patients in the Emergency Department

NCT06351826 | Recruiting

• 1 other identifier: 22070876
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is the response time of polytrauma patients who receive ELLASI in the intervention group faster than the control group?
2. 2.Is the deterioration score of polytrauma patients who receive ELLASI in the intervention group better than the control group?
3. 3.Is the metabolic status of polytrauma patients who receive ELLASI in the intervention group better than the control group?
4. 4.Evaluation of airway and cervical control, remove the foreign body, fluid, etc., from the airway,
5. 5.Patient positioning and giving oxygen, head-up,
6. 6.Stabilisation, including IV insertion, applying pressure and bandage, place monitor, and haemodynamic monitoring
7. 7.Assessment: re-assessment of pain and other main complaints
8. 8.Make sure informed consents are documented
9. 9.Inform patient and family for further intervention

Conditions

Polytrauma

Outcome Measures

Primary Outcomes (5)

• Response time

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

  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

  Immediately before the intervention start and 3 hours after the intervention end

• Acidic Level (pH)

  Measure pH of arterial blood gas

  Immediately before the intervention start and 3 hours after the intervention end

• Base Excess (BE)

  Measure BE of arterial blood gas

  Immediately before the intervention start and 3 hours after the intervention end

• Bicarbonate level (HCO3)

  Measure HCO3 of arterial blood gas

  Immediately before the intervention start and 3 hours after the intervention end

Study Arms (2)

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

Other: ELLASI

Standard

ACTIVE COMPARATOR

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

Other: Standard

Interventions

ELLASI OTHER

A structured intervention for polytrauma patients

ELLASI

Standard OTHER

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

Standard

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Polytrauma patients
• Have not received medical treatment before

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

RSCM

Jakarta Pusat, West Java, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Nurlaelah

CONTACT

06281299225207; adeleyla77@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effectiveness of ELLASI Intervention Towards Response Time, Deterioration, and Metabolic Status of Polytrauma Patients in the Emergency Department

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: April 8, 2024
• Study Start: January 3, 2024
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)