| CTRI Number |
CTRI/2023/04/051849 [Registered on: 21/04/2023] Trial Registered Prospectively |
| Last Modified On: |
19/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Gastric Volume Using Ultrasound In Adult Patient Posted For Emergency Lower Limb Surgery |
|
Scientific Title of Study
|
A Prospective Observational Study Of Preoperative Assessment Of Gastric Content And Volume Using Ultrasound In Adult Patients Posted For Emergency Lower Limb Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishali Chaskar |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Anaesthesia Department,
Seth GS Medical College and KEM Hospital,
Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9987261071 |
| Fax |
|
| Email |
vc2482@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Chaskar |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Anaesthesia Department,
Seth GS Medical College and KEM Hospital,
Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9987261071 |
| Fax |
|
| Email |
vc2482@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Chaskar |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Anaesthesia Department,
Seth GS Medical College and KEM Hospital,
Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9987261071 |
| Fax |
|
| Email |
vc2482@gmail.com |
|
|
Source of Monetary or Material Support
|
| KEM hospital emergency operation theatre of surgery and orthopaedic surgery |
|
|
Primary Sponsor
|
| Name |
Dr Vaishali Chaskar |
| Address |
Anaesthesia Department,
Seth GS Medical College and KEM Hospital,
Mumbai. |
| Type of Sponsor |
Other [Municipal Corporation College and Hospitals] |
|
|
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 Vaishali Prabhakar Chaskar |
Seth GSMC and KEM Hospital |
Parel mumbai
Mumbai
MAHARASHTRA |
9987261071
vc2482@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients coming for emergency lower limb surgeries may be associated with multiple systemic diseases. Significant gastric volume will help to take preventive step to avoid risk of aspiration. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing emergency lower limb surgery.
ASA grade I II III |
|
| ExclusionCriteria |
| Details |
Patient not willing to participate.
Pregnant patient .
Patient with nasogastric tube in situ.
Patient who are not able to lie on right lateral position. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe percentage of populaDon with significant gastric volume |
15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out correlation between fasting time and gastric volume .
To check gastric volume difference in patients with delayed gastric emptying like DM,CKD , Obesity with patients without any co morbidities. |
15 months |
|
|
Target Sample Size
|
Total Sample Size="155"
Sample Size from India="155"
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)
|
01/05/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Once a study is finished, we will try to publish it. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aspiration of gastric contents during peri-operative period is a grave complication with significant morbidity and mortality. Condition associated with delayed gastric emptying predisposes them to an increased risk of aspiration then the general population. Per- operative fasting guidelines helps to prevent the risk of aspiration in elective surgeries. However, fasting intervals differ in patients posted for emergency surgeries and patients with co-morbidities like DM, obesity and CKD. Ultrasound is widely available and has been proven to be reliable bedside assessment tool for real time evaluation of gastric content and volume in tertiary care centres. Gastric ultrasound examination care tool for aspiration risk assessment which includes measuring and calculation of gastric content and volume in DM, Obesity and CKD patients who’s are posted for emergency lower limb surgeries. Primary aim of this study to observe percentage of population with significant content and volume. |