| CTRI Number |
CTRI/2022/04/041851 [Registered on: 13/04/2022] Trial Registered Prospectively |
| Last Modified On: |
12/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO ESTIMATE THE PREOPERATIVE STOMACH VOLUME IN PATIENTS WHO FOLLOW OVERNIGHT FASTING AND THOSE HAVING ORAL FLUIDS BEFORE 2 HOURS OF SURGERY BY ULTRASOUND EXAMINATION |
|
Scientific Title of Study
|
Ultrasonographic estimation of preoperative gastric volume in patients following overnight fasting and those allowed oral fluids until 2 hours before surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandini V Raj |
| Designation |
Assistant Professor |
| Affiliation |
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
OT Complex
Dr B R Ambedkar Medical College And Hospital
Kadugondanahalli
Bangalore
OT Complex
Dr B R Ambedkar Medical College and Hospital
Kadugondanahalli
Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9886563752 |
| Fax |
|
| Email |
nandinivraj@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harsoor S S |
| Designation |
Head Of Department |
| Affiliation |
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
OT Complex
Dr B R Ambedkar Medical College and Hospital
Kadugondanahalli
Bangalore
OT Complex
Dr B R Ambedkar Medical College and Hospital
Kadugondanahalli
Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9845279426 |
| Fax |
|
| Email |
harsoorss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Varsha Pavithran |
| Designation |
Post Graduate |
| Affiliation |
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
OT Complex
Dr B R Ambedkar Medical College and Hospital
Kadugondanahalli
Bangalore
OT Complex
Dr B R Ambedkar Medical College and Hospital
Kadugondanahalli
Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9008230556 |
| Fax |
|
| Email |
varsha27.5@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
DR NANDINI V RAJ |
| Address |
OT COMPLEX
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL
KADUGONDANAHALLI
BANGALORE |
| Type of Sponsor |
Other [SELF] |
|
|
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 Nandini V Raj |
Dr B R Ambedkar Medical College and Hospital |
OT Complex
Dr B R Ambedkar Medical College and Hospital
Kadugondanahalli
Bangalore
Bangalore
KARNATAKA |
9886563752
nandinivraj@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMITTEE, DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)PATIENTS AGED BETWEEN 18-50 YEARS POSTED FOR ELECTIVE SURGERIES
2)ASA GRADE I AND II PATIENTS |
|
| ExclusionCriteria |
| Details |
1)PATIENT REFUSAL
2)PATIENTS TAKING ANTACIDS,H2 RECEPTOR BLOCKERS,OPIOID ANALGESICS,METOCLOPRAMIDE
3)PATIENTS WITH A HISTORY OF ANY GASTROINTESTINAL DISORDER,DIABETES MELLITUS
4)PREGNANT WOMEN |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure residual gastric volume in patients following overnight fasting and those allowed oral fluids until 2 hours before surgery by gastric ultrasonography |
Gastric volume assessment by gastric ultrasonography will be done just before the patient is taken up for surgery in the pre-operative care unit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/04/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 ONE OF THE MOST SERIOUS COMPLICATIONS OF ANAESTHESIA, ASSOCIATED WITH HIGH MORBIDITY AND MORTALITY. IT CAN RESULT IN SEVERE PNEUMONIA REQUIRING MECHANICAL VENTILATOR SUPPORT IN ONE THIRD OF PATIENTS. EXTRAPOLATION OF PREVIOUS STUDIES REPORTED THAT CRITICAL VOLUME FOR SEVERE ASPIRATION IN ADULT HUMANS COULD BE BETWEEN 25-50 ML(0.4-0.8ML/KG). THEREFORE IT WOULD OF INTEREST TO PERFORM AN EASY NON INVASIVE BEDSIDE TEST TO HELP THE PHYSICIAN IN THE ASSESSMENT OF VOLUME OF GASTRIC CONTENTS. WITH THE ADVENT OF PORTABLE ULTRASOUND MACHINE, GASTRIC ULTRASOUND IS FINDING A PLACE AS A POINT-OF-CARE TOOL FOR ASPIRATION RISK ASSESSMENT. VARIOUS PREVIOUS STUDIES PERFORMED ON VOLUNTEERS SUGGESTED THAT THE MEASUREMENT OF ANTRAL CROSS SECTIONAL AREA IS A USEFUL NON INVASIVE TEST TO DETERMINE GASTRIC CONTENTS AND VOLUME. HENCE THIS PROSPECTIVE OBSERVATIONAL STUDY WILL BE CONDUCTED TO EVALUATE THE VOLUME OF GASTRIC CONTENTS IN PATIENTS FOLLOWING OVERNIGHT FASTING AND THOSE ALLOWED ORAL FLUIDS UNTIL 2 HOURS BEFOERE ELECTIVE SURGERY AS ASSESSED BY ULTRASONOGRAPHIC MEASUREMENT OF ANTRAL AREA. |