Effectiveness of ELLASI Intervention Towards Polytrauma Patients in the Emergency Department

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Polytrauma
• Intervention / Treatment: Other: ELLASI; Other: Standard

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nurlaelah; Phone Number: 06281299225207; Email: adeleyla77@gmail.com

Study Locations

• Indonesia
  • Jawa Barat
    • Jakarta Pusat, Jawa Barat, Indonesia, 10430
      • Recruiting
      • RSCM
      • Contact: RSCM; Phone Number: 062211500135; Email: info@rscm.co.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Polytrauma patients
• Have not received medical treatment before

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ELLASI; Polytrauma patients in the intervention group will receive a-6-points structured intervention abbreviated with ELLASI: Evaluasi: Evaluation of airway and cervical control, remove the foreign body, fluid, etc., from the airway; Letakkan: patient positioning and give oxygen, head-up.; Lakukan: Stabilisasation, including IV insertion, applying pressure and bandage, place monitor, haemodynamic monitoring; Assessment: re-assessment of pain and other main complaints; Siapkan: make sure informed consents are documented; Informasikan: inform patient and family for further intervention	Other: ELLASI; A structured intervention for polytrauma patients
Active Comparator: Standard; Polytrauma patients in the control group will receive the usual/standard intervention.	Other: Standard; Unstructured interventions that are given in everyday practice (standard intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2024
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease Attributes; Emergencies; Multiple Trauma
• Other Study ID Numbers: 22070876

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will only be shared with supervisors for consultation. Due to privacy and anonymity, no participants' identifiers that will be disclosed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No