| 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
|
|
|
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
|
|
|
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
|
|
|
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 |
|
|
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. |