| CTRI Number |
CTRI/2022/04/042010 [Registered on: 21/04/2022] Trial Registered Prospectively |
| Last Modified On: |
20/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of risk of aspiration of stomach contents into lungs, by using abdomen scan, in patients undergoing surgeries. |
|
Scientific Title of Study
|
Assessment of the perioperative aspiration risk,in specific patient subgroups by using gastric ultrasound. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Sathyasuba |
| Designation |
Assistant Professor |
| Affiliation |
Sree Balaji Medical College and Hospital |
| Address |
Department of Anesthesiology,
Sree Balaji Medical College and Hospital,
#7 CLC Works road,
Chromepet ,
Chennai.
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
9791421124 |
| Fax |
|
| Email |
drsathyasuba@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sathyasuba |
| Designation |
Assistant Professor |
| Affiliation |
Sree Balaji Medical College and Hospital |
| Address |
Department of Anesthesiology,
Sree Balaji Medical College and Hospital,
#7 CLC Works road,
Chromepet ,
Chennai.
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
9791421124 |
| Fax |
|
| Email |
drsathyasuba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Sathyasuba |
| Designation |
Assistant Professor |
| Affiliation |
Sree Balaji Medical College and Hospital |
| Address |
Department of Anesthesiology,
Sree Balaji Medical College and Hospital,
#7 CLC Works road,
Chromepet ,
Chennai.
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
9791421124 |
| Fax |
|
| Email |
drsathyasuba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Balaji Medical College and Hospital,Chromepet,Chennai 44. |
|
|
Primary Sponsor
|
| Name |
Sree Balaji Medical College and Hospital Chennai |
| Address |
No.7,CLC Works road,Chromepet,Chennai 44. |
| 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 |
| Dr M Sathyasuba |
Sree Balaji Medical College and Hospital |
3 and 4th floor OT Complex, Department of Anesthesiology,
No.7,CLC Works road,
Chromepet,
Chennai 600044.
Kancheepuram
TAMIL NADU |
9791421124
drsathyasuba@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL. |
| Comparator Agent |
NIL |
NIL |
| Comparator Agent |
NIL. |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1,2,3
1.Patients with Type 2 Diabetes mellitus
2.Obese patients
3.Patients with dyspepsia/Gastro esophageal reflux disease |
|
| ExclusionCriteria |
| Details |
1.Patients who refuse
2.Pregnancy
3.Morbid obese
4.Patients with major cardiopulmonary issues and unable to lie supine. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlating the duration of fasting with presence of gastric contents by ultrasound |
At once on the morning of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measuring the exact volume of gastric contents by a formula that employs gastric antrum diameter. |
At once, on the morning of surgery. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
24/04/2022 |
| 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="0"
Months="4"
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)?
Response - NO
|
|
Brief Summary
|
Perioperative aspiration of gastric contents is an always dreaded upon complication by anesthesiologists,in terms of morbidity and mortality.The gastric volume’s nature and quantity contributes to the severity of aspiration pneumonitis,with the greatest risk being posed by particulate matter..We can utilise the bedside ultrasound as a quick,easy non invasive .less expensive tool in the preoperative arena,to estimate the perioperative aspiration risk.In our study,we intend to compare three patient subgroups,namely,Type 2 DM uncontrolled,Obesity,and history of dyspepsia/GERD,which has not been done much,earlier. |