| CTRI Number |
CTRI/2023/03/051118 [Registered on: 28/03/2023] Trial Registered Prospectively |
| Last Modified On: |
25/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of ultrasound done in emergency department in patients with suspected kidney stone |
|
Scientific Title of Study
|
Utility Of Point of Care Ultrasound in Patients with suspected renal colic presenting to Emergency Medicine Department: KEYSTONE study |
| Trial Acronym |
KEYSTONE STUDY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr AKASH K |
| Designation |
postgraduate student |
| Affiliation |
KASTURBA MEDICAL COLLEGE MANIPAL |
| Address |
DEPT OF EMERGENCY MEDICINE KMC MANIPAL UDUPI MANIPAL KARNATKA DEPT OF EMERGENCY MEDICINE KMC MANIPAL UDUPI MANIPAL KARNATKA Udupi KARNATAKA 576104 India |
| Phone |
7353604889 |
| Fax |
|
| Email |
kallure1997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jayaraj Mymbilly Balakrishnan |
| Designation |
Professor and Head |
| Affiliation |
KASTURBA MEDICAL COLLEGE MANIPAL |
| Address |
DEPT OF EMERGENCY MEDICINE KMC MANIPAL UDUPI MANIPAL KARNATKA DEPT OF EMERGENCY MEDICINE KMC MANIPAL UDUPI MANIPAL KARNATKA Udupi KARNATAKA 576104 India |
| Phone |
9895063580 |
| Fax |
|
| Email |
jayaraj.mb@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr AKASH K |
| Designation |
postgraduate student |
| Affiliation |
KASTURBA MEDICAL COLLEGE MANIPAL |
| Address |
DEPT OF EMERGENCY MEDICINE KMC MANIPAL UDUPI MANIPAL KARNATKA DEPT OF EMERGENCY MEDICINE KMC MANIPAL UDUPI MANIPAL KARNATKA Udupi KARNATAKA 576104 India |
| Phone |
7353604889 |
| Fax |
|
| Email |
kallure1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College hospital , Manipal |
|
|
Primary Sponsor
|
| Name |
Dr AKASH K |
| Address |
Dept of Emergency Medicine, Kasturba Medical College, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akash K |
Kasturba Hospital, Manipal |
Dept of Emergency medicine new trauma building Ground floor , Kasturba Hospital, Near Tiger circle, Madhavnagar, Manipal Udupi KARNATAKA |
7353604889
kallure1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL ETHICS COMMITTE 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N23||Unspecified renal colic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
POINT OF CARE ULTRASOUND IN PATIENT PRESENTING WITH LOIN TO GROIN PAIN. |
This is a prospective observational study to be conducted in the Emergency Medicine Department of Kasturba medical college and Hospital, Manipal
Patients with suspected renal colic who fulfil inclusion criteria will be enrolled into the study after taking informed consent. Point of care ultrasound as per the KEYSTONE Protocol will be performed by trained emergency physicians who are accredited by the local PCPNDT regulatory body.
After focused history and check listed clinical examination, point of care ultrasound protocol (KEYSTONE protocol) will be carried out in patients with renal colic. It includes a formatted checklist of differential diagnosis, which will be assessed sequentially:
1. Kidney: Presence hydroureteronephrosis with grading and other pertinent findings
2. Abdominal aorta: Aneurysmal dilatation/ dissection
3. Appendix: Enlargement/ collection.
4. Free fluid in abdomen and pelvis.
5. Gall bladder pathologies – Cholelithiasis, cholecystitis
6. Lower lobe pneumonia.
The findings will be noted in the preassigned data collection form
The treatment of the patient will be simultaneously carried out without interruption or delay. As per the existing protocol of the department, the patient will undergo pertinent radiological imaging (ultrasound by radiologist or CT scan) as per treating physician’s discretion. The POCUS findings will not be shared with the radiologist. The findings in the further imaging will be noted for comparison. Also, Individual advice regarding follow up of case will be recorded
A 30-day telephonic follow-up, along with review of medical records of patient, if done in the same institution, will be done. The purpose is to note for passage of stone by the participants and any urological intervention or repeat hospital Emergency Medicine Department visits, admissions, OPD follow-up in the 1 month.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged >18 years with suspected renal colic presenting to Department of Emergency Medicine.
|
|
| ExclusionCriteria |
| Details |
1. Patients not consenting to participate in the study.
2. Patients who will not be undergoing further radiological investigations for confirmation of diagnosis after Point of Care Ultrasound
3. Patients with intrauterine gestation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The sensitivity and specificity of point of care ultrasound performed by emergency physicians for detecting hydroureteronephrosis in patients with suspected renal colic |
At presentation to Emergency Department,
Follow up at 30 days since presentation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The correlation of the results of the KEYSTONE protocols with the radiological and clinical findings and outcomes for detecting other time-senstive emergencies such as aortic aneurysm, appendicitis |
At presentation to Emergency Department,
Follow up at 30 days since presentation |
|
|
Target Sample Size
|
Total Sample Size="133" Sample Size from India="133"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Utility
of Point of Care Ultrasound in patients with suspected renal colic presenting
to Emergency Medicine Department KEYSTONE study.
Our objective is to determine the sensitivity and specificity of Point of
care ultrasound performed by Emergency physicians for detecting
hydroureteronephrosis in patients with suspected renal colic. We would also like to validate KEYSTONE protocol in detecting key emergent
differential diagnosis such as aortic aneurysm, appendicitis in patients with suspected renal colic. Renal colic is one of the most
common presentations in the Emergency Medicine Department. It is important to
rule out emergent differential diagnoses like abdominal aortic aneurysm,
ectopic pregnancy, acute appendicitis lower lobe pneumonia, gall bladder
pathologies etc. in such patients. We propose that point of care ultrasound done
by Emergency Physician can quickly rule out hydroureteronephrosis and other
differential diagnosis and accelerate disposition in such patients. This will
help to triage patients who require urgent further imaging modalities and
interventions and other resource allocations. This will also help to improve
the ED turn-around time for these patients. Point of care
ultrasound is bedside ,routinely done standard of care test in emergency
department to detect, life threating emergencies early. In our study point of
care ultrasound is done to detect hydroureteronephrosis in patients with
suspected renal colic (loin to groin pain ) and also to pick up other
differentials as mentioned below .and to compare sensitivity and specificity of
point of care ultrasound in picking of this emergencies with the standard
radiological investigations like USG/CT scan. Point of care ultrasound is
bedside routinely done examination no extra charges /cost is added to the
patients. Description of study process: This is a prospective observational study to be conducted
in the Emergency Medicine Department of Kasturba medical college and Hospital,
Manipal. Patients with suspected renal colic who fulfil inclusion
criteria will be enrolled into the study after taking informed consent. Point
of care ultrasound as per the KEYSTONE Protocol will be performed by trained
emergency physicians who are accredited by the local PCPNDT regulatory body. After focused history and check listed clinical examination,
point of care ultrasound protocol (KEYSTONE protocol) will be carried out in
patients with renal colic. It includes a formatted checklist of differential
diagnosis, which will be assessed sequentially: (Titled as KEYSTONE protocol) 1.
Kidney: Presence hydroureteronephrosis
with grading and other pertinent findings
2.
Abdominal aorta:
Aneurysmal dilatation/ dissection
3.
Appendix:
Enlargement/ collection.
4.
Free fluid in
abdomen and pelvis.
5.
Gall bladder
pathologies – Cholelithiasis, cholecystitis
6.
Lower lobe pneumonia.
The findings will be noted in the preassigned data
collection form
The treatment of the patient will be simultaneously
carried out without interruption or delay. As per the existing protocol of the
department, the patient will undergo pertinent radiological imaging (ultrasound
by radiologist or CT scan) as per treating physician’s discretion. The POCUS
findings will not be shared with the radiologist. The findings in the further
imaging will be noted for comparison. Also, Individual advice regarding follow
up of case will be recorded. A 30-day telephonic follow-up, along with review of
medical records of patient, if done in the same institution, will be done. The
purpose is to note for passage of stone by the participants and any urological
intervention or repeat hospital, repeat Emergency Medicine Department visits,
admissions, OPD follow-up in the 1 month. The sensitivity and specificity of point of care
ultrasound performed by emergency physicians for detecting
hydroureteronephrosis in patients with suspected renal colic. The correlation of the results of the KEYSTONE protocols
with the radiological and clinical findings and outcomes including follow up
findings will be done. |