| CTRI Number |
CTRI/2025/03/083737 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Presence of obesity and co relation of respiratory events in
paediatric surgical population during surgery and after surgery: a prospective, observational study. |
|
Scientific Title of Study
|
Prevalence of obesity and association of perioperative respiratory events in
paediatric surgical population: a prospective, observational study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Snehal Bhaidas Tare |
| Designation |
Fellow paediatric anaesthesia |
| Affiliation |
NH SRCC Children’s Hospital |
| Address |
Department of anaesthesia, 3rd floor, NH SRCC children’s hospital, Mumbai
Haji Ali , Mumbai, Maharashtra,India.
Mumbai
MAHARASHTRA
400034
India |
| Phone |
8451928360 |
| Fax |
|
| Email |
snehalt1094@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SNEHAL BHAIDAS TARE |
| Designation |
Fellow paediatric Anaesthesia |
| Affiliation |
NH SRCC Children’s Hospital |
| Address |
205, Kasheli , Sakhu niwas , Bhiwandi , Thane
Haji Ali , Mumbai, Maharashtra
Mumbai
MAHARASHTRA
421302
India |
| Phone |
8451928360 |
| Fax |
|
| Email |
snehalt1094@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Snehal Bhaidas Tare |
| Designation |
Fellow paediatric anaesthesia |
| Affiliation |
NH SRCC Children’s Hospital, Mumbai. |
| Address |
Department of anaesthesia, 3 rd floor , NH SRCC children’s hospital, Mumbai
Haji Ali, Mumbai, Maharashtra, India.
Mumbai
MAHARASHTRA
400034
India |
| Phone |
8451928360 |
| Fax |
|
| Email |
snehalt1094@gmail.com |
|
|
Source of Monetary or Material Support
|
| NH SRCC Childrens Hospital, Haji Ali, Mumbai |
|
|
Primary Sponsor
|
| Name |
NH SRCC Childrens Hospital Haji ali Mumbai |
| Address |
Department of anaesthesia,3rd floor, NH SRCC children’s Hospital, Haji Ali, Mumbai, Maharashtra , India.
400034 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Snehal Tare |
NH SRCC Children’s Hospital |
3rd floor, Department of anesthesia.
Haji Ali, Mumbai, India.
400034
Mumbai
MAHARASHTRA |
8451928360
snehal1094@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The SRCC Childrens Hospital Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y848||Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 2 years to 18 years who are undergoing elective and emergency surgeries under general anesthesia and regional anesthesia or sedation.
|
|
| ExclusionCriteria |
| Details |
children less than 2 years
children under going cardiac surgery
children undergoing procedure under local anesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the prevalence of overweight and obesity in pediatric patients undergoing surgeries requiring anesthesia. |
Time duration is total number of hours of anesthesia that is dependent on type and duration of surgery.
Range of time duration : 1 hour to 6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study association of other comorbidities.
2. Incidence of perioperative respiratory adverse events.
3. Difficulties in airway management.
4. Difficulty in securing intravenous cannula.
5. A difficulty encountered during regional anesthesia
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="209"
Sample Size from India="209"
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)
|
09/04/2025 |
| 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="0"
Months="6"
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
|
The purpose of this study assess the prevalence of obesity in paediatric patients posted for surgery and association of perioperative respiratory events Methods- 209 patients, between 2 – 18 years, who were operated between January to June 2023 at our institute were selected for the study. Patient characteristic, co-morbidity, and perioperative data were collected to ascertain the risks associated with overweight and obese children. Weight groups were defined based on age- and gender- specific BMI/weight for height cutoff. Chi square and Mid P exact test were used to compare proportions and independent t tests were used to compare means (significant p < 0.05). |