CTRI Number |
CTRI/2019/02/017677 [Registered on: 14/02/2019] Trial Registered Prospectively |
Last Modified On: |
28/12/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Other |
Public Title of Study
Modification(s)
|
To study the volume of stomach contents using ultrasound |
Scientific Title of Study
Modification(s)
|
Ultrasound-guided estimation of gastric residual volume using Perlas’ formula: A validation study in patients undergoing elective surgery |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Priya Ranganathan |
Designation |
Professor |
Affiliation |
Tata Memorial Centre |
Address |
Department of Anaesthesiology
Room No 210, Main Building
Tata Memorial Hospital
Ernest Borges Road
Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
Phone |
9967971878 |
Fax |
|
Email |
drpriyaranganathan@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Sayali Khandekar |
Designation |
Junior Resident |
Affiliation |
Tata Memorial Centre |
Address |
Department of Anaesthesiology
Room No 210, Main Building
Tata Memorial Hospital
Ernest Borges Road
Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
Phone |
9869384848 |
Fax |
|
Email |
sayalikhandekar@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Sayali Khandekar |
Designation |
Junior Resident |
Affiliation |
Tata Memorial Centre |
Address |
Department of Anaesthesiology
Room No 210, Main Building
Tata Memorial Hospital
Ernest Borges Road
Parel, Mumbai
Osmanabad MAHARASHTRA 400012 India |
Phone |
9869384848 |
Fax |
|
Email |
sayalikhandekar@gmail.com |
|
Source of Monetary or Material Support
|
Tata Memorial Hospital, Parel, Mumbai 400012 |
|
Primary Sponsor
|
Name |
No funding |
Address |
Not applicable |
Type of Sponsor |
Other [Not applicable] |
|
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 |
Priya Ranganathan |
Tata Memorial Hospital |
Room 210, Department of Anaesthesia, Main Building, Tata Memorial Hospital, Ernest Borges Road, Parel Mumbai MAHARASHTRA |
9967971878
drpriyaranganathan@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Institutional Ethics Committee 1 Tata memorial Hospital |
Approved |
Institutional Ethics Committee-1, Tata Memorial Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Adult healthy volunteers who give consent to participate in the study. |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
not applicable |
not applicable |
Intervention |
USG guided estimation |
All USG assessments will be performed by 2 trained anaesthesiologists (JRD and PR) who have completed at least 50 such examinations prior to starting the study.
At a convenient time during the day, participants will undergo baseline USG guided estimation of GRV. Following this, the investigators (JRD, PR) will be asked to leave the room while the participant consumes a fixed volume of fluid (depending on randomisation arm)
Within five minutes (to minimise the effect of gastric emptying), a repeat USG-guided assessment of GRV will be performed. Investigators will be blinded to measurements performed by each other and to the randomisation arm
|
|
Inclusion Criteria
Modification(s)
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Male |
Details |
All adult patients who give consent to participate in the study, who are not required to remain fasting (i.e., not posted for surgery or any other procedure which needs fasting)
Exclusion Criteria:
1. Co-morbidities that delay gastric emptying [e.g Diabetics, morbid obesity (BMI>40), Pregnancy, pyloric stenosis]
2. Intestinal obstruction
3. Gastric or Oesophageal malignancy or pathology
4. Therapy with opioids, antacids or prokinetics
5. History of acid peptic disease or gastric reflux.
|
|
ExclusionCriteria |
Details |
Refusal of consent |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To measure the accuracy of measurement of gastric volume using USG (and Perlas’ formula) |
5 minutes after consumption of a fixed quantity of water or milk (to be decided by randomization) |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. To examine whether type of fluid – clear (water) or particulate (milk) affects the agreement |
5 minutes after consumption of a fixed quantity of water or milk (to be decided by randomization) |
To look at inter-rater agreement in GRV measurements |
5 minutes after consumption of a fixed quantity of water or milk (to be decided by randomization) |
To examine whether volume of fluid (100 versus 200 ml) affects the accuracy of measurement |
5 minutes after consumption of a fixed quantity of water or milk (to be decided by randomization) |
|
Target Sample Size
|
Total Sample Size="25" Sample Size from India="25"
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)
|
01/03/2019 |
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="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
postgraduate thesis
No publication yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Aspiration of gastric content is a serious perioperative event associated with morbidity and mortality. Patients with a “full stomach†are at increased aspiration risk when sedation or general anaesthesia impair their lower oesophageal sphincter tone and protective airway reflexes. Several studies have used bedside ultrasound to evaluate GRV to assess perioperative aspiration risk and guide anaesthetic management. The purpose of this study is to examine whether the use of bedside ultrasound and Perlas’ formula by trained anaesthesiologists can accurately measure gastric volume in patients undergoing elective surgery who have consumed various quantities of different types of liquids. |