| CTRI Number |
CTRI/2024/09/073704 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of PRAm and NARCO-SS risk assessment scores |
|
Scientific Title of Study
|
Comparison of PRAm and NARCO-SS risk assessment scores in assessing perioperative
outcomes in paediatric patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meshach R |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9043111800 |
| Fax |
|
| Email |
meshachr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nisha Sara M Jacob |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9500574751 |
| Fax |
|
| Email |
nishasara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nisha Sara M Jacob |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9500574751 |
| Fax |
|
| Email |
nishasara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Meshach R |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Madhav Nagar, Manipal, Karnataka - 576104 |
| 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 Nisha Sara M Jacob |
Kasturba Medical College, Manipal |
Department of Anaesthesiology, Kasturba Medical College, Madhav Nagar, Manipal, Karnataka - 576104
Udupi
KARNATAKA |
9500574751
nishasara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective or emergency non-cardiac surgery
Patients less than 18 years of age of either gender |
|
| ExclusionCriteria |
| Details |
Patients involved in other studies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare the accuracy of PRAm and NARCO-SS scores in predicting perioperative
outcomes among paediatric patients |
Intraoperative, immediate postoperative period while in
postanaesthesia care unit, each postoperative day until discharge and weekly telephonic follow-up
until 30th postoperative day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Inter-observer reliability of PRAm and NARCO-SS |
During preoperative assessment of the patient |
|
|
Target Sample Size
|
Total Sample Size="377"
Sample Size from India="377"
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)
|
10/09/2024 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective observational cohort study comparing the Pediatric Risk Assessment score (PRAm) and the Neurological, Airway, Respiratory, Cardiovascular, Other and Surgical severity (NARCO-SS) score. The primary objective is to compare the accuracy of PRAm and NARCO-SS scores in predicting perioperative outcomes among paediatric patients. The participants will be assessed prior to the surgery and scores will be assigned from the both scoring systems. The participants will then be then be followed up for 30 days after the surgery. The perioperative outcomes that will be recorded are predefined.
The secondary objective is to determine the inter-observer reliability of PRAm and NARCO-SS scores. A subset of the participants will be assessed prior to surgery by multiple observers and they will assign scores from both PRAm and NARCO-SS. This subset will be used to determine the secondary objective.
References - PRAm
Nasr VG, DiNardo JA, Faraoni D. Development of a Pediatric Risk Assessment Score to Predict Perioperative Mortality in Children Undergoing Noncardiac Surgery. Anesth Analg 2017; 124: 1514–1519.
- NARCO-SS
Malviya S, Voepel-Lewis T, Chiravuri SD, et al. Does an objective system-based approach improve assessment of perioperative risk in children? A preliminary evaluation of the ‘NARCO’. Br J Anaesth 2011; 106: 352–358.
|