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CTRI Number  CTRI/2022/07/044422 [Registered on: 28/07/2022] Trial Registered Prospectively
Last Modified On: 06/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   The use of ultrasound to evaluate the stomach contents in trauma and non-trauma patients posted for surgery 
Scientific Title of Study   Role of point-of-care ultrasound (POCUS) in assessing gastric residual volume in trauma and non-trauma patients scheduled for elective surgery - a prospective cohort study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chhavi Sawhney 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, Room No.125, Jai Prakash Narayan Apex Trauma Centre (JPNATC)
AIIMS, New Delhi
South West
DELHI
110029
India 
Phone  9818357051  
Fax    
Email  drchhavisawhney@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Chhavi Sawhney 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, Room No.125, Jai Prakash Narayan Apex Trauma Centre (JPNATC)
AIIMS, New Delhi
South West
DELHI
110029
India 
Phone  9818357051  
Fax    
Email  drchhavisawhney@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Basil Koshy Sajeev  
Designation  Junior Resident, Academic 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, Room No.5012, Academic Block
AIIMS, New Delhi
South West
DELHI
110049
India 
Phone  8826683494  
Fax    
Email  basilkoshysajeev@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi - 110029 
 
Primary Sponsor  
Name  Chhavi Sawhney 
Address  Professor, Department of Anaesthesiology, Pain Medicine and Critical Care, JPNATC, AIIMS, New Delhi - 110029 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Department of Anaesthesiology Pain Medicine and Critical Care  All India Institute of Medical Sciences, New Delhi - 110029 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Chhavi Sawhney  AIIMS, New Delhi  Department of Anaesthesiology, Pain Medicine and Critical Care, Room No.5012, Academic Block
South West
DELHI 
9818357051

drchhavisawhney@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T07||Unspecified multiple injuries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult patients with trauma, with history of trauma within the previous one week, and those without trauma, above 18 years of age and belong to ASA physical status I, II or III, scheduled to undergo elective surgery 
 
ExclusionCriteria 
Details  1. Patients with history of prior gastric or lower oesophageal surgery
2. Patients with known abnormalities of the upper gastrointestinal tract (such as hiatal hernia and gastric tumors)
3. Pregnancy
4. Patients unable to turn and lie in lateral position
5. Patients with BMI more then 35 kg/m2
6. Patients who are not able to understand the study procedure and provide informed written consent 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess gastric residual volume in trauma patients scheduled for elective surgery following standard ASA fasting guidelines  Pre-operative period before induction of anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare gastric residual volume between trauma and non-trauma patients scheduled for elective surgery following standard ASA fasting guidelines
2. To assess risk of aspiration using the antral grading system developed by Perlas et al
3. To find correlation between the measured gastric residual volume with duration after trauma and any underlying co-morbidities (diabetes mellitus, chronic kidney disease, hypothyroidism) in trauma patients 
Pre-operative period, before induction of anaesthesia  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   01/08/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Pulmonary aspiration of gastric contents is a rare but serious complication of anaesthesia. Significant pulmonary complications happen in almost half of patients who aspirate and almost 50% of deaths in anaesthesia are directly due to aspiration of gastric contents, which occurs more commonly in patients with risk factors, at the time of  induction of anaesthesia or during airway instrumentation.1 The practice guidelines of American Society of Anesthesiologists (ASA) for healthy adults consider a minimum fasting duration of 2 hrs for clear fluids, 6 hrs for a light meal and 8 hrs for a fatty meal, fried foods or meat to be safe so as to reduce the risk of aspiration of gastric contents. However, uncertainty still exists regarding the exact gastric residual volume (GRV) that places the patients at increased risk of aspiration despite following standard fasting guidelines.2 
Trauma patients are at increased risk of pulmonary aspiration of gastric contents, because trauma affects gastric motility and emptying, in addition to many of the trauma patients having inadequate fasting status. Gastric emptying is highly dependent on an intact central nervous system, and is decreased in spinal cord trauma. It is generally assumed that there is delayed gastric emptying early in the post-trauma period, but there is less quantitative data concerning this patient population.3
Point-of-care ultrasound (POCUS) has been used in other studies to qualitatively assess the gastric contents and the risk of aspiration, and to quantitatively estimate the gastric residual volume (GRV) by measuring the antral cross-sectional area (ACSA).4 POCUS is relatively cheaper and easier to use bedside modality for this purpose in comparison to other modalities like gastric content aspiration, electrical impedance tomography, MRI and gastric scintigraphy.5 Gastric antrum scanned first with the patient in supine position and then in right lateral decubitus (RLD) position, can be used to for the same. Risk of aspiration can be assessed using the antral grading system developed by Perlas et al where empty antrum in both supine and RLD positions would be grade 0 indicating an empty stomach and minimum risk of aspiration, clear fluid in RLD position but empty in supine position would be grade 1 indicating an intermediate stomach, and clear fluid in both supine and RLD positions would be grade 2 indicating a full stomach, and is associated with maximum risk of aspiration.6
POCUS can be used to measure gastric antral cross-sectional area (ACSA) in RLD position of the patient using the following formula:7
ACSA = (CC × AP) ×  with p = 3.14, where CC and AP are the cranio-caudal and antero-posterior diameters of the antrum respectively.  
Gastric residual volume can then be estimated from ACSA using the following formula:8
Stomach volume (mL) = 27 + 14.6 ACSA (in cm2) - 1.28 age (in years)
We hypothesized that trauma patients scheduled for elective surgery after standard fasting guidelines and satisfying inclusion and exclusion criteria, will have a significantly higher GRV in comparison to non-trauma patients. We thus aim to assess the gastric residual volume in trauma patients using POCUS as primary objective, and to compare GRV in trauma patients and non-trauma patients, to assess risk of aspiration using the antral grading system, and to correlate measured GRV with duration after trauma and underlying co-morbidities if any, as secondary objectives.

REFERENCES
1. Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31
2. Ohashi Y, Walker JC, Zhang F, Prindiville FE, Hanrahan JP, Mendelson R, Corcoran T. Preoperative gastric residual volumes in fasted patients measured by bedside ultrasound: a prospective observational study. Anaesth Intensive Care. 2018 Nov;46(6):608-613
3. Carlin CB, Scanlon PH, Wagner DA, Borghesi L, Geiger JW, Long CL. Gastric Emptying in Trauma Patients. Dig Surg 1999;16:192-196
4. Shorbagy MS, Kasem AA, Gamal Eldin AA, Mahrose R. Routine point-of-care ultrasound (POCUS) assessment of gastric antral content in traumatic emergency surgical patients for prevention of aspiration pneumonitis: an observational clinical trial. BMC Anesthesiol. 2021 May 8;21(1):140
5. Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22
6. Perlas A, Davis L, Khan M, Mitsakakis N, Chan VW. Gastric sonography in the fasted surgical patient: a prospective descriptive study. Anesth Analg. 2011 Jul;113(1):93-7
7. Bolondi L, Bortolotti M, Santi V, Calletti T, Gaiani S, Labò G. Measurement of gastric emptying time by real-time ultrasonography. Gastroenterology. 1985 Oct;89(4):752-9
8. Perlas A, Mitsakakis N, Liu L, Cino M, Haldipur N, Davis L, Cubillos J, Chan V. Validation of a mathematical model for ultrasound assessment of gastric volume by gastroscopic examination. Anesth Analg. 2013 Feb;116(2):357-63

 
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