CTRI Number |
CTRI/2019/11/022139 [Registered on: 25/11/2019] Trial Registered Prospectively |
Last Modified On: |
21/11/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Single Arm Study |
Public Title of Study
|
A study to find out the volume of the contents of the stomach in patients with kidney failure and fasting before undegoing surgery |
Scientific Title of Study
|
Ultrasound evaluation of gastric residual volume in fasting end-stage renal failure patients |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sushma K |
Designation |
PG Resident |
Affiliation |
MS Ramaiah Medical College |
Address |
Department of Anaesthesiology 2nd floor
Ramaiah Medical College Hospital
New BEL Road
Bangalore
Bangalore KARNATAKA 560054 India |
Phone |
080-40502860 |
Fax |
|
Email |
sushmakothapalli55@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Tejesh CA |
Designation |
Professor |
Affiliation |
MS Ramaiah Medical College |
Address |
Department of Anaesthesiology 2nd floor
Ramaiah Medical College Hospital
New BEL Road
Bangalore
Bangalore KARNATAKA 560054 India |
Phone |
080-40502860 |
Fax |
|
Email |
drtejeshca@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sushma K |
Designation |
PG Resident |
Affiliation |
MS Ramaiah Medical College |
Address |
Department of Anaesthesiology 2nd floor
Ramaiah Medical College Hospital
New BEL Road
Bangalore
KARNATAKA 560054 India |
Phone |
080-40502860 |
Fax |
|
Email |
sushmakothapalli55@gmail.com |
|
Source of Monetary or Material Support
|
MS Ramaiah Medical College
MSRIT Post
New BEL Road
Bangalore-560054 |
|
Primary Sponsor
|
Name |
MS Ramaiah Medical College |
Address |
MSRIT Post
New BEL Road
Bangalore-560054 |
Type of Sponsor |
Private 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 |
DrSushma K |
MS Ramaiah Medical Teaching Hospital |
Department of Anaesthesiology
2nd floor
Operation theatre complex
MS Ramiah Medical Teaching Hospital
New BEL Road
Bangalore-560054 Bangalore KARNATAKA |
9945517222
sushmakothapalli55@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics Committee MS Ramiah Medical College and Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Ultrasound examination of gastric antrum |
In patients with end-stage renal failure who are fasting overnight ultrasound examination of gastric antrum is performed to evaluate the contents and volume |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Age 20-60 years
Body mass index < 40kg/m2
End-stage renal failure |
|
ExclusionCriteria |
Details |
History of upper gastrointestinal disease
Previous surgery on esophagus or stomach
Previous upper abdominal surgery
Pregnancy |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To calculate the gastric residual volume and nature of gastric contents |
To calculate the gastric residual volume and nature of gastric contents 30 min before anaesthesia induction |
|
Secondary Outcome
|
Outcome |
TimePoints |
None |
None |
|
Target Sample Size
|
Total Sample Size="186" Sample Size from India="186"
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)
|
01/12/2019 |
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
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Pulmonary
aspiration of gastric contents is a serious perioperative complication. The
Fourth National Audit Project by the Royal College of Anaesthetists has
reported pulmonary aspiration as the cause of more than 50% of airway-related
deaths in anaesthesia. The resulting respiratory compromise is
thought to be related to both volume and nature of the aspirate. The most commonly used measure to prevent aspiration is fasting before
anaesthesia, and anaesthesia societies have developed guidelines for
preoperative fasting. However, these guidelines apply to healthy
patients undergoing elective surgery and not reliable in patients with
co-morbidities that affect gastric emptying.
Gastric
emptying is known to be delayed in patients with end-stage renal failure.
Though certain biochemical markers have been shown to be associated with delayed
gastric emptying in patients with chronic renal failure, there is no acceptable
method of identifying such patients before anaesthesia. Gastric
ultrasound has recently evolved into a simple, point-of-care tool for
evaluating gastric content and volume. The gastric antrum can be easily
identified using a low frequency curvilinear probe. By visualising the antrum,
not only the contents of the stomach can be determined, but also quantification
is possible by application of suitable validated methods. There is
paucity of literature with respect to the use of gastric ultrasound to
determine residual volume in patients with end-stage renal failure. Hence, the
present study is designed to evaluate the gastric contents and volume in
patients with end-stage renal failure by gastric ultrasound. |