| CTRI Number |
CTRI/2023/11/059626 [Registered on: 07/11/2023] Trial Registered Prospectively |
| Last Modified On: |
18/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of
gastric content and volume in obese patients its comparison with non-obese |
|
Scientific Title of Study
|
Preoperative ultrasonographic assessement of gastric content and volume in obese patients and its comparison with non-obese |
| 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 Anand kumar |
| Designation |
Resident Anaesthesiologist |
| Affiliation |
Employees State Insurance Corporation Postgraduate Institute Of Medical Science and Research |
| Address |
Room no.2207, Department of Anaesthesia, 2nd floor OT complex,ESI Hospital Basaidarapur,ring road West Delhi-110015
West
DELHI
110015
India |
| Phone |
8095156907 |
| Fax |
|
| Email |
anandpg14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil thakur |
| Designation |
Professor and HOD |
| Affiliation |
Employees State Insurance Corporation Postgraduate Institute Of Medical Science and Research |
| Address |
Room no.2210, Department of Anaesthesiology,2nd floor, OT Complex,ESI Basaidarapur, ring road West Delhi 110015,India
West
DELHI
110015
India |
| Phone |
935010337 |
| Fax |
|
| Email |
dranilthakur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand kumar |
| Designation |
Resident Anaesthesiologist |
| Affiliation |
Employees State Insurance Corporation Postgraduate Institute Of Medical Science and Research |
| Address |
Room no.2207,Department of Anaesthesiology, 2nd floor, OT Complex,ESI Basaidarapur, ring road West Delhi-110015,India
West
DELHI
110015
India |
| Phone |
8095156907 |
| Fax |
|
| Email |
anandpg14@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI Postgraduate Institute Of Medical Science and Research New Delhi-110015 |
|
|
Primary Sponsor
|
| Name |
ESI Postgraduate Institute Of Medical Science and Research New Delhi-110015 |
| Address |
Basaidarapur, ring road West Delhi-110015 |
| 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 |
| DrAnand kumar |
ESIC, Hospital, Basaidarapur |
Second floor OT, Department of Anaesthesia, ESIC-PGIMSR, Basaidarapur Ring road, West Delhi
West
DELHI |
8095156907
anandpg14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC ESI PGIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K90-K95||Other diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasonography of abdomen |
Scanning of epigastric using ultrasound machine to measure gastric content and volume. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASI grade I and II,
Surgical cases posted for elective surgery |
|
| ExclusionCriteria |
| Details |
Pregnancy,
Diabetes Mellitus
Emergency surgeries
History of surgery of upper gastrointestinal morbidity
Connective tissue disorder affecting gastrointestinal motility
Nasogastric in situ
Previous abdominal or oesophageal surgery
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the gastric residual volume and content in obese and non obese schedule for surgery under general anaesthesia. |
Time point:Preoperative . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess whether addition of gastric ultrasound assessment in Preoperative period will result in any changes in anaesthetic management of patients undergoing elective surgery.
To manage any episode of regurgitation/aspiration and post op nausea, vomiting accordingly.
|
Preoperative area on the day of surgery. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
15/11/2023 |
| 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="0"
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
|
Aim is to assess the usefulness of USG for determination of gastric content and volume in obese patients scheduled for elective surgery. Study is prospective observational study. Seventy two patients will be enrolled for the study after inclusion and exclusion criteria. Written informed consent will be taken from patients. Patients will be divided into two groups on the bases of BMI more than 30 and less than 30. All patients will be undergoing ultrasonographic scan of abdomen on the day of surgery in Preoperative room to measure gastric residual volume and content. Primary objective is to assess gastric residual volume in obese and non obese patients. |