ClinicalTrials.Veeva

Menu

Pre-hospital Notification of Injured Patients Presenting to Trauma Centres in India

T

Teresa Howard

Status

Unknown

Conditions

Major Trauma

Treatments

Other: Pre-hospital notification

Study type

Observational

Funder types

Other

Identifiers

NCT02877342
GCF020013-PHN

Details and patient eligibility

About

A prospective observational study using an interrupted time-series design to evaluate the effect of pre-hospital notification on trauma patients arriving at a trauma centre by ambulance, in India

Full description

This is a longitudinal prospective cohort study of injured patients being transported by ambulance to the major trauma centre study sites. In the pre-intervention phase, prospective data on patients will be collected on pre-hospital assessment, notification, in-hospital assessment, management and outcomes and recorded in a new tailored multi-hospital trauma registry. All injured patients arriving by ambulance and allocated to a red or yellow priority category will be eligible for inclusion. The intervention will be a pre-hospital notification application in the form of an Android program that will be used by ambulance clinicians to notify emergency departments of selected hospitals of an impending arrival of a patient. The application will use a simple algorithm based on trauma triage principles developed by the Australia-India Trauma System Collaboration (AITSC). The proportion of severely injured patients arriving to hospital after notification will be the primary outcome measure with a target of 70%. Secondary outcomes evaluated will be availability of a trauma cubicle, presence of a trauma team on patient arrival, time to first chest x-ray and in-hospital mortality.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: All injured patients arriving by ambulance and allocated to a red (1st) or yellow (2nd) priority category will be eligible for inclusion. Data will be collected prospectively by trained data collectors positioned in the trauma centres.

Retrospective inclusion will be continued for all screened patients presenting to any of the included hospitals with injury (including near-drowning) as the primary diagnosis and with at least one of the following criteria:

  1. Admission to hospital
  2. Death after triage but before admission
  3. Dead on arrival

Exclusion criteria: Patients meeting screening criteria will be subsequently excluded if they meet any of the following criteria:

  1. Dead at scene
  2. Alive at triage but not admitted to hospital (discharged alive)
  3. Isolated poisoning
  4. Isolated burns
  5. Single digit finger or toe amputations (unless of the thumb or great toe), only

Trial design

500 participants in 2 patient groups

Pre-intervention
Description:
All injured patients arriving by ambulance (to the four intervention sites) and allocated to a red (1st) or yellow (2nd) priority category will be eligible for inclusion. Patients arriving without notification buy ambulance service
Post-Intervention
Description:
All injured patients arriving by ambulance, and allocated to a red (1st) or yellow (2nd) priority category will be eligible for inclusion. Patients arriving with and without notification by the ambulance service using the pre-hospital notification application.
Treatment:
Other: Pre-hospital notification

Trial contacts and locations

4

Loading...

Central trial contact

Biswadev Mitra, MBBS, PhD; Mathew Joseph, MBBS

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems