| CTRI Number |
CTRI/2021/08/035894 [Registered on: 24/08/2021] Trial Registered Prospectively |
| Last Modified On: |
19/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
USG ESTIMATION OF GASTRIC CONTENT AND VOLUME IN PREOPERATIVE FASTING PATIENTS POSTED FOR ELECTIVE SURGERY: A PROSPECTIVE OBSERVATIONAL STUDY |
|
Scientific Title of Study
|
ULTRASONOGRAPHIC ESTIMATION OF GASTRIC CONTENT AND VOLUME IN PREOPERATIVE FASTING PATIENTS POSTED FOR ELECTIVE SURGERY: A PROSPECTIVE OBSERVATIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Malashree |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Institute of Trauma And Orthopedics |
| Address |
Department of Anesthesia Sanjay Gandhi Institute Of Trauma And Orthopedics Byrasandra Jayanagar Bengaluru
Sanjay Gandhi Institute Of Trauma And Orthopedics Byrasandra Jayanagar Bengaluru
Bangalore
KARNATAKA
560011
India |
| Phone |
9164872173 |
| Fax |
|
| Email |
mala17gokule@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Malashree |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Institute of Trauma And Orthopedics |
| Address |
Sanjay Gandhi Institute Of Trauma And Orthopedics, Byrasandra, Jayanagar Bengaluru
Sanjay Gandhi Institute Of Trauma And Orthopedics, Byrasandra, Jayanagar Bengaluru
KARNATAKA
560011
India |
| Phone |
9164872173 |
| Fax |
|
| Email |
mala17gokule@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Malashree |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Institute of Trauma And Orthopedics |
| Address |
Department of Anesthesia Sanjay Gandhi Institute Of Trauma And Orthopedics Byrasandra Jayanagar Bengaluru
Sanjay Gandhi Institute Of Trauma And Orthopedics Byrasandra Jayanagar Bengaluru
Bangalore
KARNATAKA
560011
India |
| Phone |
9164872173 |
| Fax |
|
| Email |
mala17gokule@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Institute Of Trauma And Orthopedics |
| Address |
Sanjay Gandhi Institute Of Trauma And Orthopedics, Byrasandra, Jayanagar Bengaluru |
| Type of Sponsor |
Government medical college |
|
|
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 Malashree |
Major Operation Theatre Sanjay Gandhi Institute of Trauma and Orthopedics |
Sanjay Gandhi Institute of Trauma & Orthopedics Byrasandra Jayanagar
Bangalore
KARNATAKA |
9164872173
mala17gokule@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sanjay Gandhi institute Of Trauma And Orthopedics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S422||Fracture of upper end of humerus, (2) ICD-10 Condition: S821||Fracture of upper end of tibia, |
|
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Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-60 yrs.
Patients of either gender
Patients posted for elective surgery
BMI >18.5 and < 34.9
ASA 1 & 2 |
|
| ExclusionCriteria |
| Details |
Patient Refusal
Pregnant women
Patients with Gastroesophageal reflux disease, or Antacid medication use
Patients with recent Gastroesophageal bleed / Gastroesophageal surgery (Hiatal Hernia Surgery, Fundoplication, Gastrectomy etc.)
Patients with chronic Renal or Hepatic Disease, Significant Cardiovascular abnormality.
Patients with Neuromuscular disease.
Patients with mental/ psychological disorder
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine any correlation between number of hours of fasting and Gastric content and volume estimation by Ultrasonography in patients posted for elective surgery.
|
1 day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
1 day
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/08/2021 |
| 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
|
ULTRASONOGRAPHIC ESTIMATION OF GASTRIC CONTENT AND VOLUME IN PREOPERATIVE FASTING PATIENTS POSTED FOR ELECTIVE SURGERY: A PROSPECTIVE OBSERVATIONAL STUDY |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Perioperative aspiration of gastric contents is a serious complication of anaesthesia and is associated with high morbidity and mortality. It can result in severe pneumonia requiring mechanical ventilator support in up to one-third of patients with a mortality of 5%, representing up to 9% of all anaesthesia-related deaths. The severity of the resulting respiratory compromise is thought to be related to both the volume and nature of the aspirate, with particulate matter carrying the highest risk. Preoperative fasting guidelines help limit the risk in elective patients with minimal co-morbidities. However, fasting intervals are not applicable or reliable in urgent or emergency surgeries or for patients with certain medical conditions. In anaesthesiology and acute care medicine, there is a growing interest in bedside evaluation of gastric ‘fullness’ to assess pulmonary aspiration risk. With the advent of portable ultrasound machines, performing point-of-care ultrasound has become relatively easy and feasible. Gastric ultrasound examination is finding a place as a point-of-care tool for aspiration risk assessment. It can identify the nature of the gastric content, i.e., empty, clear fluid and solid and when clear fluid is present, its volume can be quantified. With this we aim to determine the efficiency of Ultrasound in determining the gastric volume and content is performed and to correlate with the fasting guidelines.
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