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CTRI Number  CTRI/2018/05/013695 [Registered on: 04/05/2018] Trial Registered Prospectively
Last Modified On: 01/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   COMPARISON BETWEEN TWO DIFFERENT SCORING SYSTEM FOR ANAESTHESIA RISK CALCULATION IN CHILDREN [PAEDIATRIC VERSION OF SILVERMAN-HOLT AGGREGATE PREOPERATIVE EVALUATION (SHAPE) AND AMERICAN SOCIETY OF ANAESTHESIOLOGISTS PHYSICAL STATUS (ASA PS) GRADING] 
Scientific Title of Study   ANAESTHESIA RISK STRATIFICATION: COMPARISON BETWEEN PAEDIATRIC VERSION OF SILVERMAN-HOLT AGGREGATE PREOPERATIVE EVALUATION (SHAPE) AND AMERICAN SOCIETY OF ANAESTHESIOLOGISTS PHYSICAL STATUS (ASA PS) GRADING SYSTEMS IN CHILDREN 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SUNILKUMAR RAMESHWAR SATAO 
Designation  RESIDENT DOCTOR 
Affiliation  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL 
Address  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL, SION, MUMBAI-400022
Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai-400022 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA
400022
India 
Phone  9422105639  
Fax    
Email  satav2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR ANILA D MALDE 
Designation  PROFESSOR AND HEAD  
Affiliation   
Address  PROFESSOR AND HEAD, DEPARTMENT OF ANAESTHESIOLOGY, LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL, SION, MUMBAI-400022
Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai-400022 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA
Dr Anila D Malde
India 
Phone  9821085730  
Fax    
Email  dradmalde@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DR ANILA D MALDE 
Designation  PROFESSOR AND HEAD  
Affiliation   
Address  PROFESSOR AND HEAD DEPARTMENT OF ANAESTHESIOLOGY, LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL, SION, MUMBAI-400022
Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai-400022 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA
Dr Anila D Malde
India 
Phone  9821085730  
Fax    
Email  dradmalde@yahoo.com  
 
Source of Monetary or Material Support  
LokmanyaTilak Municipal Medical college and General Hospital 
 
Primary Sponsor  
Name  SUNILKUMAR RAMESHWAR SATAO 
Address  LokmanyaTilak Municipal Medical college and General Hospital 
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 SUNILKUMAR SATAO  LokmanyaTilak Municipal Medical college and General Hospital  LokmanyaTilak Municipal Medical college and General Hospital, Sion Mumbai -400022
Mumbai
MAHARASHTRA 
9422105639

satav2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lokmanya Tilak Municipal Medical College and General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Comparison of pediatric version of SHAPE score with ASA PS grading system in children as predictor for perioperative complications and requirement of escalation of care. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Any child scheduled for surgery or monitored anesthesia care
2. Parent/Guardians giving valid informed consent
 
 
ExclusionCriteria 
Details  None 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To correlate and compare ediatric version of SHAPE score and ASA PS preoperative evaluation system with
a. Intraoperative and postoperative complications /events in children
b. Requirement of escalation of care
 
Intraoperative and postoperative period 
 
Secondary Outcome  
Outcome  TimePoints 
To compare pediatric version of SHAPE score and ASA PS preoperative evaluation system with respect to
a. Assessment of children’s condition and risk factors in children
b. Explaining the risk of anesthesia to parents and relatives
c. Resource management
 
Perioperative period 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   11/05/2018 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Children scheduled for the various surgical procedures and satisfying the inclusion and exclusion criteria will be included in this study. Each child’s relevant history will be taken. Through examination will be done. Laboratory parameters and other investigations will be noted.

 

Each child will be assigned ASA PS score and pediatric version of SHAPE score. 

 

The same child will be again evaluated as per SHAPE’s scoring system.

1.   ASA score of each system will be given as per SIS (SHAPE’s Individual Systems score). 

2.   Surgical risk / invasiveness will be scored.

3.   Physical features affecting mask ventilation will be scored.

4.   Intubation difficulty predicting features will be scored.

5.   Any special risk related to anesthesia will be graded.

6.   Final ‘ASA PS’ score will be given as single digit with extra suffice ‘E’ for emergency surgery. Final ‘SHAPE’ score will be given in the range 1,1,0,0 to 5,5,5,5 and additional risk indicator if any.

 

Both completed evaluation forms will be given to anesthetist in charge of that case. The intraoperative and postoperative anaesthesia care plan including premedication, induction, ion etc. will be according to attending anesthesiologist’s discretion. After the surgery, his/her opinion about both scoring systems will be taken in the form of questionnaire.

 

Intra-operative and post-operative complications will be followed up till patient is discharged from intensive care unit.

 

Descriptive statistic about height, weight sex will be noted. Intra operative and post-operative complications and requirement of escalation of care will be noted.

 

Relation between categorical and dichotomous variable will be analyzed by univariate and multivariate logistic regression models using SPSS. Odds ratio and 95% confidence intervals will also be calculated during bivariate logistic regression analysis. Comparison between area under curve (AUC) of two receivers operating characteristic (ROC) curves will be carried out.

 
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