Effectiveness of ELLASI Intervention Towards Polytrauma Patients in the Emergency Department

Polytrauma Clinical Trial

Official title:

Effectiveness of ELLASI Intervention Towards Response Time, Deterioration, and Metabolic Status of Polytrauma Patients in the Emergency Department

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06351826
• Other study ID #: 22070876
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Indonesia University
• Contact: Nurlaelah
• Phone: 06281299225207
• Email: adeleyla77[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Polytrauma patients

• Have not received medical treatment before

Exclusion Criteria:

• Canceled registration

• Polytrauma patients who are unwilling to participate in the study

Related Conditions & MeSH terms

• Emergencies
• Multiple Trauma
• Polytrauma

Intervention

Other:
• ELLASI
A structured intervention for polytrauma patients
• Standard
Unstructured interventions that are given in everyday practice (standard intervention)

Locations

Country	Name	City	State
Indonesia	RSCM	Jakarta Pusat	Jawa Barat

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response time	Documented from the beginning of ELLASI and standard interventions are delivered to the ending.	Immediately before and after the intervention
Primary	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
Primary	Acidic Level (pH)	Measure pH of arterial blood gas	Immediately before the intervention start and 3 hours after the intervention end
Primary	Base Excess (BE)	Measure BE of arterial blood gas	Immediately before the intervention start and 3 hours after the intervention end
Primary	Bicarbonate level (HCO3)	Measure HCO3 of arterial blood gas	Immediately before the intervention start and 3 hours after the intervention end