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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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