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CTRI Number  CTRI/2025/02/081195 [Registered on: 24/02/2025] Trial Registered Prospectively
Last Modified On: 18/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE OBSERVATIONAL STUDY 
Study Design  Other 
Public Title of Study   Gastric ultrasound in children undergoing neurosurgeries 
Scientific Title of Study   Ultrasound assessment of gastric volume in children with raised intracranial pressure undergoing neurosurgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavyashree M B 
Designation  Senior Resident 
Affiliation  NIMHANS, Bengaluru 
Address  Dept of Neuroanesthesia and critical care Nimhans campus, Hosur road Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9481628489  
Fax    
Email  kavyambn@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shwethashri KR 
Designation  Associate Professor 
Affiliation  NIMHANS, Bengaluru 
Address  Dept of Neuroanesthesia and critical care Nimhans campus, Hosur road Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9916964747  
Fax    
Email  shwethashri.84@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kavyashree M B 
Designation  Senior Resident 
Affiliation  NIMHANS, Bengaluru 
Address  Dept of Neuroanesthesia and critical care Nimhans campus, Hosur road Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9481628489  
Fax    
Email  kavyambn@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  National Institute of Mental Health and Neurosciences 
Address  Nimhans Hospital, Hosur Road, near Lakkasandra, Wilson garden Bengaluru PIN CODE 560029 
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 Kavyashree M B  National Institute of Mental Health and Neurosciences  Department of Neuroanesthesia and critical care Nimhans hospital, Hosur Road, near Lakkassandra, Wilson garden Bengaluru- 560029
Bangalore
KARNATAKA 
9481628489

kavyambn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMHANS ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  All pediatric neurosurgical patients between the age of 2-14 years with clinical and radiological features (dilated ventricles, midline shift, effacement of cerebral sulci, compressed basal cisterns, herniation on CT brain) suggestive of raised intracranial pressure scheduled to undergo neurosurgeries under general anaesthesia 
 
ExclusionCriteria 
Details  1. Children with gastrointestinal disorders, surgery to the oesophagus or upper abdomen,
2. Preoperatively intubated patients
3. Refusal of consent
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess gastric volume in paediatric neurosurgical population with raised intracranial pressure (clinical and radiological) undergoing neurosurgeries.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. To correlate the preoperative fasting status & the gastric volume.
2. To assess peri-intubation adverse events (vomiting, aspiration of gastric contents).
 
Baseline  
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   07/03/2025 
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="0"
Months="6"
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   This is a prospective observational study involving pediatric neurosurgical patients with raised intracranial pressure undergoing neurosurgeries admitted to NIMHANS.
After obtaining written, informed consent from the parents or legal guardian data will be collected for the study. Preoperative assessment will be done by the attending anesthesiologist. 
Gastric ultrasound examination:
Assessments will be conducted in the operating room, ward or preoperative holding area as per convenience so as not to delay the surgery. It will be done in two positions; Supine and Right lateral decubitus. Both qualitative (type of content) and quantitative (volume) assessments of gastric content will be performed and documented. A low-frequency curvilinear transducer will be used for large pediatric patients, while a linear high- frequency transducer will be used for patients under 40kg. 
The patient will be placed on the operating table with their upper abdomen exposed, and conducting gel will be utilised as an acoustic medium. The patient will first be scanned while supine, and subsequently when they are in the right lateral decubitus (RLD) position. The stomach is visualised in the epigastric region on a sagittal plane, directly beneath the xiphoid and above the umbilicus. The antrum is located directly inferior to the left lobe of the liver. It resembles a superficial hollow viscus with a thick, multilayered wall. The inferior vena cava and the aorta are located posterior to the antrum. The amount of stomach fluid is quantitatively assessed using a standardised plane at the level of the aorta.
Using a high- frequency transducer, the five sonographic layers of the stomach wall will be seen while it is empty. From the inner to the outer surface, the five layers are as follows; The mucosal-air contact, muscularis mucosa, submucosa, muscularis propria and serosa. Only the muscularis propria is reliably seen when using a low-frequency transducer. Based on qualitative data, the nature of stomach content (empty, clear fluid, thick fluid/solid) can be determined.
1. Empty stomach- antrum flat or ovoid with no content.
2. Clear fluid content- antrum distended with homogenous hypoechoic or anechoic content.
3. Thick fluid or solid content- antrum distended with heterogenous hyperechoic or grossly particular content.
Qualitative assessment of gastric antrum will be done by the 3-point grading system
Grade 0- absence of content in a flattened antrum in both positions
Grade 1- fluid content visible only in the right lateral decubitus position
Grade 2- fluid content noticeable in both the RLD and supine positions
If clear fluid is present (grade 1 and grade 2 antrum) cross-sectional area will be calculated in the RLD position using the free tracing method (FTM) by using an ultrasound machine’s calipers to trace the circumference of the antrum including the outermost serosal layer.
The gastric volume will then be derived from the formula
Volume (ml)= -7.8 + (3.5 x CSA in RLD in cm2)) + (0.127 x age in months)
After qualitative and quantitative assessment, findings will be summarised as
1) empty stomach (no fluid or solid content visible)
2) low volume of clear fluid (<1.25ml/kg) consistent with baseline gastric secretions
3) high volume of clear fluid (>1.25ml/kg) suggesting greater than baseline gastric secretions
4) thick fluid or solid content.
A stomach will be categorised as "full" if there is evidence of any solid, echogenic content in the antrum with volume >1.5ml/kg) and "high risk" if there is evidence of any solid, echogenic content in the antrum with volume >1.25ml/kg. Peri-intubation events such as vomiting and aspiration of gastric contents will be noted.



 
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