TraumaPCP-KNCT04577924
Pre-hospital Care Profile of Road Traffic Injury Victims- Kerala
An observational study of Trauma and Road (Traffic) Accident [RTA] Nos, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
Trial summary
Selection of appropriate strategies and correct policy-making in these conditions may lead to decreased rates of death due to RTI.There is a lack of research on the effectiveness of pre-hospital care in Kerala. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Trauma, Road (Traffic) Accident [RTA] Nos
- What is being tested?
- Interview
- How many people
- 978 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2019to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All RTI patients presenting to ED within 24 hours of injury irrespective of gender, race or comorbidities involved in an RTI would be approached to be recruited for the study.
Who may be able to join
- All Road traffic injury (RTI) patients presenting to ED within 24 hours of injury
Who cannot join
- Individual's not consenting to be part of the study or withdrawing consent later on
- Cases where pre-hospital care provider could not be traced or where reliable patient data could not be collected even after repeated interview.
Trial locations and contacts
1 site in 1 country.
India1 site
Jubilee Mission Medical College and Research Institute
Thrissur, Kerala, 680005
About this study
Official title: Pre-hospital Care Profile of Road Traffic Injury Victims Presenting to the Emergency Department of a Tertiary Care Centre in Kerala, a Cross-sectional Study
Selection of appropriate strategies and correct policy-making in these conditions may lead to decreased rates of death due to RTI.There is a lack of research on the effectiveness of pre-hospital care in Kerala. This study aimed to describe the prehospital care of RTI victims presenting to the emergency department in Jubilee Mission Medical College and Research Institute, Thrissur.
Read the detailed description
Management of trauma is a neglected field in developing nations.Road Traffic Injuries (RTI) cause around 1.35 million deaths worldwide annually according to the statistics of World Health Organization (WHO) and in India 150000 death per year. An overwhelming proportion of these deaths occur before patients even reach the hospital. Two third (60.7%) of the accident victims belonged to the age range of 15 to 44 years. This indicates that active and productive age people are the one affected by road traffic accidents related injuries in turn adding to higher economic loss to the country. Lack of medical attention is attributed to nearly 30 per cent of deaths at site and 80 per cent of the remaining patients died within an hour of injury (golden hour). Most of these deaths are due to airway management failure, respiratory failure or continuing hemorrhage that are preventable causes with appropriate prehospital and subsequent hospital emergency care. Mortality due to RTI is increasing, especially in Low and Middle Income Countries (LMIC). There is a lack of research on the effectiveness of pre-hospital care in India. Selection of appropriate strategies and correct policy-making in these conditions may lead to decreased rates of death due to RTI in several countries.This study aimed to describe the prehospital care of RTI victims presenting to the emergency department (ED) in Jubilee Mission Medical College and Research Institute, Thrissur.
- Conditions
- Trauma, Road (Traffic) Accident [RTA] Nos
- Being tested
- Interview
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Trained research assistants would abstract the data as per a preset proforma. The data would be collected from the patient (if coherent), pre-hospital care provider or primary care provider.
Data would was also obtained from patient records and the proforma filled by the attending doctors on duty.
Follow up of cases would be done until discharge from the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Road traffic injury victims | All RTI patients presenting to ED within 24 hours of injury is included in the study..
Individual's not consenting to be part of the study or withdrawing consent later on would be excluded. We also would exclude cases where pre-hospital care provider could not be traced or where reliable data patient could not be collected even after repeated interview. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-hospital care profile of RTI Victims presenting to the emergency department in a tertiary care center in Kerala as measured by a questionnaire.
Pre-hospital care received by RTI Victims presenting to the emergency department in a tertiary care center in Kerala
Measured: Hospital admission days through discharge; up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Jan 2019
- Primary completion30 Apr 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 978 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jubilee Mission Medical College and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sr. Alphonsa Mathew, Jubilee Mission Medical College and Research Institute
- Investigators
- Salish Varghese, MD, Study chair, salishvarghese@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577924
- Sponsor's protocol ID
- 36/18/IEC/JMMC&RI
- Other IDs
- CTRI/2019/03/018160
- Acronym
- PCP-K
- Status last verified
- Feb 2021
- First submitted
- 29 Sep 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data would be shared once published in a peer reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-hospital Care Profile of Road Traffic Injury Victims Presenting to the Emergency Department of a Tertiary Care Centre in Kerala, a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04577924
- Acronym / sponsor ID
- PCP-K / 36/18/IEC/JMMC&RI
- Conditions
- Trauma, Road (Traffic) Accident [RTA] Nos
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 978 participants (actual)
- Lead sponsor
- Jubilee Mission Medical College and Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Selection of appropriate strategies and correct policy-making in these conditions may lead to decreased rates of death due to RTI.There is a lack of research on the effectiveness of pre-hospital care in Kerala. This study aimed to describe the prehospital care of RTI victims presenting to the emergency department in Jubilee Mission Medical College and Research Institute, Thrissur.
Detailed description
Management of trauma is a neglected field in developing nations.Road Traffic Injuries (RTI) cause around 1.35 million deaths worldwide annually according to the statistics of World Health Organization (WHO) and in India 150000 death per year. An overwhelming proportion of these deaths occur before patients even reach the hospital. Two third (60.7%) of the accident victims belonged to the age range of 15 to 44 years. This indicates that active and productive age people are the one affected by road traffic accidents related injuries in turn adding to higher economic loss to the country. Lack of medical attention is attributed to nearly 30 per cent of deaths at site and 80 per cent of the remaining patients died within an hour of injury (golden hour). Most of these deaths are due to airway management failure, respiratory failure or continuing hemorrhage that are preventable causes with appropriate prehospital and subsequent hospital emergency care. Mortality due to RTI is increasing, especially in Low and Middle Income Countries (LMIC). There is a lack of research on the effectiveness of pre-hospital care in India. Selection of appropriate strategies and correct policy-making in these conditions may lead to decreased rates of death due to RTI in several countries.This study aimed to describe the prehospital care of RTI victims presenting to the emergency department (ED) in Jubilee Mission Medical College and Research Institute, Thrissur.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Road traffic injury victims | – | Other: InterviewAll RTI patients presenting to ED within 24 hours of injury is included in the study.. Individual's not consenting to be part of the study or withdrawing consent later on would be excluded. We also would exclude cases where pre-hospital care provider could not be traced or where reliable data patient could not be collected even after repeated interview. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All RTI patients presenting to ED within 24 hours of injury irrespective of gender, race or comorbidities involved in an RTI would be approached to be recruited for the study.
Key inclusion criteria (1 listed)
- All Road traffic injury (RTI) patients presenting to ED within 24 hours of injury
Key exclusion criteria (2 listed)
- Individual's not consenting to be part of the study or withdrawing consent later on
- Cases where pre-hospital care provider could not be traced or where reliable patient data could not be collected even after repeated interview.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewTrained research assistants would abstract the data as per a preset proforma. The data would be collected from the patient (if coherent), pre-hospital care provider or primary care provider. Data would was also obtained from patient records and the proforma filled by the attending doctors on duty. Follow up of cases would be done until discharge from the hospital. | Other | Road traffic injury victims |
Primary outcome
Pre-hospital care profile of RTI Victims presenting to the emergency department in a tertiary care center in Kerala as measured by a questionnaire.
Time frame: Hospital admission days through discharge; up to 30 days
Pre-hospital care received by RTI Victims presenting to the emergency department in a tertiary care center in Kerala
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: Yes. Individual participant data would be shared once published in a peer reviewed journal.
Related trials for Trauma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salish Varghese, MD study chair
salishvarghese@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Road (Traffic) Accident [RTA] Nos, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-hospital care profile of RTI Victims presenting to the emergency department in a tertiary care center in Kerala as measured by a questionnaire. (time frame: Hospital admission days through discharge; up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.