| CTRI Number |
CTRI/2020/03/023840 [Registered on: 09/03/2020] Trial Registered Prospectively |
| Last Modified On: |
28/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
Pre-Anaesthesia measurement of stomach content using ultrasound machine in patients with brain diseases |
|
Scientific Title of Study
|
Pre-Anaesthesia Ultrasonographic Gastric volume assessment in patients undergoing elective/emergency intracranial Neurosurgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NO.NIMH/DO/IEC 2018-19 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kumari Pallavi |
| Designation |
PG student |
| Affiliation |
National Institute Of Mental Health and Neurosciences |
| Address |
Department of Neuroanaesthesia and Neurocritical care,National Institute Of Mental Health and Neurosciences,Hosur Road,Bengaluru-560029,Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
9643666562 |
| Fax |
|
| Email |
pallavilivestrong@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSudhir V |
| Designation |
Additional Professor |
| Affiliation |
National Institute Of Mental Health and Neurosciences |
| Address |
Department of Neuroanaesthesia and Neurocritical care National Institute Of Mental Health and Neurosciences Hosur Road Bengaluru 560029 Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
9900793108 |
| Fax |
|
| Email |
Vsudhir77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kumari Pallavi |
| Designation |
PG student |
| Affiliation |
National Institute Of Mental Health and Neurosciences |
| Address |
Department of Neuroanaesthesia and Neurocritical care,National Institute Of Mental Health and Neurosciences,Hosur Road,Bengaluru-560029,Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
9643666562 |
| Fax |
|
| Email |
pallavilivestrong@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neuro Sciences Hosur road,bengaluru 560029 karnataka india |
|
|
Primary Sponsor
|
| Name |
Kumari Pallavi |
| Address |
National Institute Of Mental Health and Neurosciences,Hosur road,Bengaluru 560029 |
| 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 |
| Kumari Pallavi |
National Institute Of Mental Health and Neurosciences |
Department of neuroanaesthesia and neurocritical care,3rd floor, faculty building,Hosur Road,Bangaluru-560029,
Bangalore
KARNATAKA |
9643666562
pallavilivestrong@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G935||Compression of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18–65 years old,Height >145 cm, weight 40–110 kg,BMI <35 kg/m2,ASA classification (I, II, III),
Elective intracranial neurosurgical procedures
|
|
| ExclusionCriteria |
| Details |
Abnormal anatomy of gastrointestinal system,patient on opioids,Diabetes Mellitus,Pregnancy,infiltrative diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses gastric volume in a patients posted for intracranial elective before induction and co-relate it with hours of fasting by measuring the gastric antral cross-sectional area using ultrasound. |
10 March 2020 to 10th april 2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the co-relation between Gastric volume and Duration of fasting in patient undergoing elective/emergency Intracranial Neurosurgery |
10th March to 10th april 2020 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/03/2020 |
| 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="1"
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)?
|
|
Brief Summary
|
Pulmonary aspiration is a serious complication leading to significant morbidity and mortality.Patients with raised intracranial pressure in condition like brain tumors are at risk of gastroparesis leading to delayed gastric emptying time.The fasting guidelines of 8 hours of fasting before anesthesia induction may not be applicable to this group of patients.So we are doing this study to find out adequate fasting duration in these patients and decrease risk of pulmonary aspiration.by using ultrasound to see the stomach just before the induction of anesthesia which is a good point of care tool |