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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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