CTRI Number |
CTRI/2020/03/024005 [Registered on: 16/03/2020] Trial Registered Prospectively |
Last Modified On: |
05/03/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Non-randomized, Multiple Arm Trial |
Public Title of Study
|
Preoperative Ultrasonographic Assessment of Gastric Volume and Fasting Hours |
Scientific Title of Study
|
Preoperative Ultrasonographic Assessment of Gastric Volume and its Co-Relation with Fasting Hours in Patients undergoing 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 Sunil N Bodamwad |
Designation |
Junior Resident in Anaesthesiology |
Affiliation |
LTMMC and LTMGH, Sion |
Address |
Department of of Anaesthesiology, LTMMC AND LTMGH, Sion, Mumbai
Mumbai MAHARASHTRA 400022 India |
Phone |
9999938164 |
Fax |
|
Email |
drsunil33@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shweta Mhamrey |
Designation |
Assistant Professor of the Department of Anaesthesiology |
Affiliation |
LTMMC and LTMGH, Sion |
Address |
Department of of Anaesthesiology, LTMMC AND LTMGH, Sion, Mumbai
Mumbai MAHARASHTRA 400022 India |
Phone |
9930804154 |
Fax |
|
Email |
mhambreyshweta@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shweta Mhamrey |
Designation |
Assistant Professor of the Department of Anaesthesiology |
Affiliation |
LTMMC and LTMGH, Sion |
Address |
Department of of Anaesthesiology, LTMMC AND LTMGH, Sion, Mumbai
Mumbai MAHARASHTRA 400022 India |
Phone |
9930804154 |
Fax |
|
Email |
mhambreyshweta@gmail.com |
|
Source of Monetary or Material Support
|
Lokmanya Tilak Municipal Medical College and Hospital , Sion, Mumbai, Maharashtra-400022. |
|
Primary Sponsor
|
Name |
Dr Sunil N Bodamwad |
Address |
Room no 102, New RMO Hostel, near LTMMC and LTMGH, Sion, Mumbai, Maharashtra-400022 |
Type of Sponsor |
Other [SELF] |
|
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 Sunil Bodamwad |
Lokmanya Tilak Municipal Medical College and General Hospital |
Operation theatres of Department of Emergency,Surgery, Uroplasty, Neurology Mumbai MAHARASHTRA |
9999938164
drsunil33@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee-Human Research |
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
|
Type |
Name |
Details |
Intervention |
NIL |
NIL |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
1. Patients aged between 18 and 80 years posted for elective surgery who will be fasted for more than 6 hours for solids and more than 2 hours for clear fluids but not more than 16 hours will be identified in the ward.
2. Such patients giving consent for performing preoperative gastric ultrasound will be included in our study.
|
|
ExclusionCriteria |
Details |
1.Pregnant women.
2.Patients with unreliable or unclear fasting history (e.g. language barrier, cognitive dysfunction, altered sensorium)
3.Patients with oesophageal or stomach pathology like achalasia cardia, hiatus hernia, CA oesophagus, CA stomach.
4.Patients who have undergone gastrectomy, gastric bypass surgery.
5.Patients who are unable to turn or lie down in lateral position.
6.Patients on drugs such as prokinetics which alter gastric motility or gastric emptying times. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
1. To preoperatively examine the gastric contents and volume in fasting patients prior to elective surgery by determining the cross sectional area(CSA) of antrum by using bedside ultrasound.
2. To determine the correlation between hours of preoperative fasting and gastric contents and volume.
|
2 Years |
|
Secondary Outcome
|
Outcome |
TimePoints |
Not Applicable |
Not Applicable |
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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)
|
20/03/2020 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Perioperative pulmonary 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. One of the main risk factors for aspiration is the presence of gastric content. The critical volume threshold of gastric fluid that by itself increases aspiration risk is controversial, but healthy, fasted patients frequently have residual gastric volumes (GVs) of up to 1.5 ml/kg without significant aspiration risk. 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. The objective is to determine the correlation between fasting times and gastric content and estimated gastric volume in patients presenting for elective surgery and also to see if the gastric contents and gastric volume are any different in patients with conditions which supposedly predispose them to delayed gastric emptying like diabetes, chronic kidney disease and obesity compared to those without such conditions. |