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CTRI Number  CTRI/2025/08/092494 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   A study using ultrasound to check the stomach before removing a breathing tube in ICU patients, to avoid problems from having an empty stomach for too long 
Scientific Title of Study   Evaluation of USG guided Pre extubation GRV (Gastric Residual Volume) measurements in relation to NBM (Nil by Mouth) duration in critically ill adult patients on mechanical ventilation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Version 2.0 dated 16.04.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shilpushp Bhosale 
Designation  Professor and head, Division of Critical care 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesia Critical Care and Pain,ACTREC,Navi Mumbai-410210

Mumbai
MAHARASHTRA
410210
India 
Phone  9619310657  
Fax    
Email  shilbhosale@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shilpushp Bhosale 
Designation  Professor and head, Division of Critical care 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesia Critical Care and Pain,ACTREC,Navi Mumbai-410210


MAHARASHTRA
410210
India 
Phone  9619310657  
Fax    
Email  shilbhosale@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradeepchand Podugu 
Designation  DM Critical care resident 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesia Critical Care and Pain,ACTREC,Navi Mumbai-410210

Mumbai
MAHARASHTRA
410210
India 
Phone  9550019927  
Fax    
Email  pradeepchand1995.pp@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Parel, Mumbai 400012 India 
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Dept of Anaesthesia, Critical care and Pain, Second floor, Main building Tata Memorial Hospital, Parel, Mumbai 400012 India 
Type of Sponsor  Research institution and hospital 
 
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 Shilpushp Bhosale  Tata Memorial Centre  Dept of Anaesthesia, Critical Care and Pain, Second floor, Main Building, Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 
9619310657

shilbhosale@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NBM group  patients kept 6 hrs of NBM pre extubation. USG guided GRV assessment done at 0 hrs and prior to extubation at 6hrs 
Intervention  Non NBM group  Patients will be NBM before extubation. GRV will be assessed at 0,2,4,6 hrs with USG and treating physician can decide extubation at 2,4 and 6 hrs depending on the aspiration risk (Gastric content by Perlas criteria ) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1) Greater than 18-year-old patients .
2)Intubated on mechanical ventilation for more than 24hrs
3) Gastric enteral feeding (at least 25percent of prescribed targets ) 
 
ExclusionCriteria 
Details  1)Routine postoperative patients on ventilation for less than 24hrs
2)Difficult access to perform gastric ultra-sounding (drains, plasters, dressings etc.)
3)Unable to Mobilize to right lateral decubitus position.
4)Anatomical anomaly of the stomach (post surgery)
5)Tracheostomised patients
6)Post pyloric enteral nutrition (jejunal tube)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare grv in pts who are fed until 2hrs before Extubation having usg guided grv measured and compared with pts who are in nbm from 6hrs.  At 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the incidence of aspiration pneumonia in patients post extubation determined by USG or New infiltrates on CXR at 24hrs  At 24 hours 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   18/08/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Majority of critically ill patients are intubated for mechanical ventilation in the icu and are enterally fed according to recent guidelines. However, no evidence-based recommendation is available regarding fasting times prior to extubation.

When an extubation is planned, patients do not always present with normal neurological status yet, and are at risk of vomiting and aspiration. Extubation may also fail and require re-intubation with similar risks. Thus, pre-operative fasting guidelines are often extrapolated to the critical care setting, aiming for an empty stomach at extubation, with perceived decreased risks of aspiration. However, the gastric and gut motility pathophysiology is significantly different in critically ill patients (frequent gastroparesis, liquid continuous feeding, etc.) compared to planned surgery patients. The extrapolation of practice validated in the later population may be inadequate. The stomach may be empty earlier than expected, leading to unnecessary prolonged fasting times. Prolonged fasting pre extubation can  predispose patient to hypoglycemic episodes, and also lead to deficit in the caloric intake over time.

Gastric ultrasound for GRV monitoring may help assessing gastric content status and the risk of aspiration prior to extubation.

Monitoring GRV involves obtaining frequent GRV measurements and employing appropriate interventions in patients with large GRVs. Gastric residual volume is an essential component of monitoring Enteral feeding to assess tolerance of feed.

 
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