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]

Not yet recruiting

• Conditions: 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.

• Registration Number: CTRI/2018/05/013695
• Lead Sponsor: SUNILKUMAR RAMESHWAR SATAO

Brief Summary

Children scheduled for thevarious surgical procedures and satisfying the inclusion and exclusion criteriawill be included in this study. Each child’s relevanthistory will be taken. Through examination will be done. Laboratory parametersand other investigations will be noted.

 Each child will beassigned 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 bescored.

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 withextra suffice ‘E’ for emergency surgery. Final ‘SHAPE’ score will begiven 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 toanesthetist in charge of that case. The intraoperative and postoperative anaesthesiacare plan including premedication, induction, ion etc. will be according toattending anesthesiologist’s discretion. After the surgery, his/her opinionabout both scoring systems will be taken in the form of questionnaire.

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

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

 Relation between categorical and dichotomous variable will be analyzedby univariate and multivariate logistic regression models using SPSS. Oddsratio and 95% confidence intervals will also be calculated during bivariatelogistic regression analysis. Comparison between area under curve (AUC) of tworeceivers operating characteristic (ROC) curves will be carried out.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-01-05
• Study Start: 2018-11-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Any child scheduled for surgery or monitored anesthesia care 2.
• Parent/Guardians giving valid informed consent.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To correlate and compare ediatric version of SHAPE score and ASA PS preoperative evaluation system with	Intraoperative and postoperative period
a. Intraoperative and postoperative complications /events in children	Intraoperative and postoperative period
b. Requirement of escalation of care	Intraoperative and postoperative period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

LokmanyaTilak Municipal Medical college and General Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

LokmanyaTilak Municipal Medical college and General Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr SUNILKUMAR SATAO

Principal investigator

9422105639

satav2@gmail.com