| 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
|
|
|
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
|
|
|
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. |