CTRI Number |
CTRI/2020/03/024083 [Registered on: 19/03/2020] Trial Registered Prospectively |
Last Modified On: |
20/10/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Ultrasound of the stomach before operation to see it’s contents in the fasting patients scheduled for surgery |
Scientific Title of Study
|
Point of care gastric ultrasound (POCGUS) for the assessment of preoperative gastric residual volume in fasting patients scheduled for elective surgery - An 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 |
Chaitra T S |
Designation |
Postgraduate student |
Affiliation |
Government medical college and hospital 32 , Chandigarh |
Address |
Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH , sector 32, Chandigarh
CHANDIGARH
160030
India
Chandigarh CHANDIGARH 160030 India |
Phone |
9482911971 |
Fax |
|
Email |
drchai94@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sanjeev Palta |
Designation |
Professor |
Affiliation |
Government medical college and hospital 32 , Chandigarh |
Address |
Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH , sector 32, Chandigarh
CHANDIGARH
160030
India
Chandigarh CHANDIGARH 160030 India |
Phone |
9646121523 |
Fax |
|
Email |
sanjeev_palta@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Richa Saroa |
Designation |
Associate Professor |
Affiliation |
Government medical college and hospital 32 , Chandigarh |
Address |
Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH , sector 32, Chandigarh
CHANDIGARH
160030
India
Chandigarh CHANDIGARH 160030 India |
Phone |
9646121513 |
Fax |
|
Email |
richajayant@rediffmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesia and Intensive care,GMCH,Chandigarh |
|
Primary Sponsor
|
Name |
Department of Anaesthesia and Intensive care |
Address |
Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH , sector 32, Chandigarh
CHANDIGARH
160030
India |
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 |
Chaitra T S |
Government medical college and hospital,Chandigarh |
Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH , sector 32, Chandigarh
CHANDIGARH
160030
India Chandigarh CHANDIGARH |
9482911971
drchai94@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Comittee, GMCH, Chandigarh |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
1. Adult patients of either sex aged between 18 to 80 years.
2. American Society of Anaesthesiologists status I-II.
3. Patients scheduled for elective surgery. |
|
ExclusionCriteria |
Details |
1. Patients with history of prior gastric or lower esophageal surgery
2. Patients with known abnormalities of the upper gastrointestinal tract (such as hiatal
hernias and gastric tumors)
3. Pregnancy
4. Patients unable to turn and lie in lateral position
5. Patients with BMI more than 35kg/m2
6. Patients who are not able to understand the study procedure and provide informed written
consent |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To use point of care gastric ultrasound for assessing the preoperative gastric residual volume in patients scheduled for elective surgery |
After 8 hours of fasting |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. To correlate the measured gastric volume with hours of fasting
2. To find correlation between the measured gastric volume with any underlying comorbidities |
After 8 hours of fasting |
|
Target Sample Size
|
Total Sample Size="400" Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "409"
Final Enrollment numbers achieved (India)="409" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/04/2020 |
Date of Study Completion (India) |
21/12/2021 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None as yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Pulmonary aspiration of gastric contents is a rare but, a serious complication of anaesthesia. Significant pulmonary complications happens in almost half of patients who aspirate and almost 50% of deaths in anaesthesia are directly due to aspiration of gastric contents, which occurs more commonly in patients with risk factors, at the time of induction of anaesthesia or during airway instrumentation. The presence of gastric contents increases the risk of aspiration and as a result practice guidelines for preoperative fasting have been designed to provide adequate time for gastric emptying in patients undergoing surgery. The practice guidelines of American Society of Anesthesiologists (ASA) for healthy adults consider a minimum fasting duration of 2 hrs for clear fluids, 6 hrs for a light meal and 8 hrs for a fatty meal, fried foods or meat to be safe. However , uncertainty still exists regarding the exact gastric residual volume(GRV) that places the patients at increased risk of aspiration despite following standard fasting guidelines. Many techniques have been described to assess the gastric contents like gastric content aspiration, paracetamol absorption, electrical impedance tomography, radio labelled diet, magnetic resonance imaging and the gold standard being gastric scintigraphy. Each modality has its pros and cons. Gastric ultrasound will be performed using a low frequency curvilinear array probe. With the advent of newer portable ultrasound (US) machines, it is possible to accurately assess the gastric contents non- invasively. Antrum It is the region of the stomach which is most amenable to ultrasonographic examination and also the portion which is most consistently identified (98- 100% cases) on ultrasonography (USG). Antral cross sectional area (CSA) calculated from gastric ultrasound highly correlates with scintigraphy and therefore cross sectional area of gastric antrum accurately predicts gastric fluid volume with the same precision as scinitgraphy. It thus helps the anaesthetist to anticipate the aspiration risk at bedside and guide anaesthetic and airway management more appropriately. Scanning was first done in the supine position followed by right lateral decubitus position. According to the appearance of the contents , qualitative assessment was done followed quantitative analysis. For the latter , antral cross sectional area (ACSA) was measured at the level of the aorta using ultrasound machine. All images were obtained between peristaltic contractions of the antrum. ACSA was measured in right lateral decubitus position using traditional two diameter method (TDM) . This involved measuring two perpendicular diameters of the antrum, from serosa to serosa, longitudinal or craniocaudal (CC), and the anteroposterior (AP) using the formula developed by Bolondi et al in which ACSA = (CC × AP) × π) / 4, with π value = 3.14. Later, using ACSA , gastric volume was calculated using the formula, Gastric volume (mL) = 27 + 14.6 ACSA (cm2) - 1.28 age (years) which is given by Perlas et al. Hence, the present study was undertaken to ascertain the gastric residual volume (GRV) by point of care gastric ultrasound in fasting patients scheduled to undergo elective surgery and correlated the same with the hours of fasting and any underlying co-morbidities. |