| CTRI Number |
CTRI/2024/01/061834 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
10/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational |
| Study Design |
Other |
|
Public Title of Study
|
Identification of stomach content and volume using ultrasonography (USG) in patients undergoing heart surgery. |
|
Scientific Title of Study
|
Assessment of gastric volume and gastric content in patient undergoing elective cardiac surgery using ultrasonography. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjeeta Umbarkar |
| Designation |
Professor(Add.) and HOD |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Cardiac Anaesthesia, Seth GS Medical College and KEM Hospital, Parel, Mumbai, Maharashtra, 400012, India
Mumbai MAHARASHTRA 400012 India |
| Phone |
9323273435 |
| Fax |
|
| Email |
sanjeeta69@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sanjeeta Umbarkar |
| Designation |
Professor(Add.) and HOD |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Cardiac Anaesthesia, Seth GS Medical College and KEM Hospital, Parel, Mumbai, Maharashtra, 400012, India
Mumbai MAHARASHTRA 400012 India |
| Phone |
9323273435 |
| Fax |
|
| Email |
sanjeeta69@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Sanjeeta Umbarkar |
| Designation |
Professor(Add.) and HOD |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Cardiac Anaesthesia, Seth GS Medical College and KEM Hospital, Parel, Mumbai, Maharashtra, 400012, India
Mumbai MAHARASHTRA 400012 India |
| Phone |
9323273435 |
| Fax |
|
| Email |
sanjeeta69@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Seth G.S Medical College and KEM hospital ,Parel ,Mumbai(Maharashtra) |
|
|
Primary Sponsor
|
| Name |
KEM hospital |
| Address |
Seth GS Medical College and KEM hospital ,parel Mumbai 400012 |
| 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 Sanjeeta Umbarkar |
Seth G.S Medical College and KEM hospital |
CVTS OT complex preoperative holding area, second floor CVTC Building Parel, Mumbai, 400012 Mumbai MAHARASHTRA |
9323273435
sanjeeta69@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) III Seth GS Medical College and KEM hospital Mumbai ,Maharashtra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q20-Q28||Congenital malformations of the circulatory system, (2) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Morning group patients versus afternoon group patients. |
It is a comparative study of gastric volume and gastric content between patients posted in morning session versus patients posted in afternoon session for elective cardiac surgery with the help of linear probe for ultrasound guidance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient age >18years and <60 years
2.Weight >40
3.BMI <35 kg/m2
4.ASA classification (I, II, III), and elective surgery
|
|
| ExclusionCriteria |
| Details |
1.Age < 18 year >60 years
2.Abnormal anatomy of the upper gastrointestinal system (previous esophagus or gastric surgery, including hiatus hernia)
3.Diabetes mellitus, subocclusive syndrome, or infiltrative diseases such as scleroderma or amyloidosis, GERD, medullar lesion above T10 level, or pregnancy.
•ASA IV
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of gastric antrum cross section area ,gastric volume and content using transthoracic ECHO
|
Baseline only one reading in the preoperative holding area just prior to administring anaesthesia
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
30/01/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pulmonary aspiration of the gastric contents is a serious perioperative
complication. The overall incidence in a mixed surgical
population ranges between <0.1% and 19% depending on patient and surgical
factors and it has not changed in the last few decades. Aspiration pneumonia is associated with significant
morbidity, including prolonged mechanical ventilation, and carries a risk of mortality as
great as 5%. Pulmonary aspiration is involved in up to 9% of all
anaesthesia-related deaths. 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−1 without significant aspiration risk. Sedation and general anaesthesia depress or impede
the physiological mechanisms that protect against aspiration (the tone of the
lower oesophageal sphincter and upper airway reflexes). Since restriction of fluid and food intake before
general anaesthesia is vital for patient safety, anaesthesiology societies have
developed guidelines for preoperative fasting.. In preoperative fasting guidelines, at
least 2 hours for clear liquids is recommended, 6 hours of fasting for liquids
containing solid particles and toasted sandwich type solid foods, and 8 hours
of fasting for high calorie and fatty foods. Patients with BMI over 30 and type 2 diabetes may benefit
from point of care ultrasonography to guide perioperative airway management by
stratifying gastric residual volume. The evaluation of gastric content by
ultrasound is a good method to qualitatively and quantitatively assess the
gastric volume and thus determine the risk of perioperative pulmonary
aspiration.As cardiac surgeries are long
duration surgeries so case posted in afternoon shift have a prolong fasting period . As per present
CVTS protocol all the patients are kept fasted from midnight so to avoid this
prolong fasting we can do sonography of stomach preoperatively to decide
whether it is needed to keep patient fasting from midnight or we can keep them
fasted from morning when posted for afternoon schedule. |