| CTRI Number |
CTRI/2023/06/054555 [Registered on: 30/06/2023] Trial Registered Prospectively |
| Last Modified On: |
29/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasound assessment of stomach contents in head injury patients |
|
Scientific Title of Study
|
Ultrasound assessment of gastric contents in patients with isolated traumatic brain injury: a prospective observational study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vendra S R |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of anaesthesia and intensive care, level 4 Nehru hospital, Post Graduate Institute of medical education and research.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09840756002 |
| Fax |
|
| Email |
vendrasr97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Bidyut Panda |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of anaesthesia and intensive care, level 4 Nehru hospital , Post Graduate Institue of Medical Education and Research.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009525 |
| Fax |
|
| Email |
nidhibp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Bidyut Panda |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of anaesthesia and intensive care, level 4 Nehru hospital , Post Graduate Institute of Medical Education and Research.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009525 |
| Fax |
|
| Email |
nidhibp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research,Sector 12, Chandigarh- 160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institiute of Medical Education and Research |
| Address |
Sector 12, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vendra S R |
Advanced Trauma Centre, Post Graduate Institiute of Medical Education and Research |
PRE OPERATIVE ROOM, TRAUMA OT COMPLEX,
Chandigarh
CHANDIGARH |
09840756002
vendrasr97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S06||Intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with moderate to severe isolated traumatic brain injury undergoing emergency neurosurgery. |
|
| ExclusionCriteria |
| Details |
1. Patients/ relatives’ refusal to participate in the study
2. Polytrauma patients
3. Patients with secured airway by endotracheal tube or tracheostomy tube.
4. Documented multiple sclerosis or Parkinsons disease
5. Patients received with a nasogastric tube in situ.
6. Patients with upper GI disease, diabetes mellitus, hypothyroidism, Obese patient (BMI >35), pregnancy, chronic renal failure.
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of full stomach (Gastric Volume more than 1.5ml/kg) in patients with moderate to severe isolated traumatic brain injury patients. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Grading of Gastric contents (qualitative)
|
Baseline |
| Gastric residual volume assessment (quantitatively) |
Baseline |
| Correlation between time of last meal intake & gastric volume assessment with USG. |
Baseline |
Correlation between increased ICP (measured by ONSD) & gastric volume status.
|
Baseline |
Incidence of aspiration described
a. Clinically in terms of fall in oxygen saturation 10mins after intubation
b. New onset radiological evidence of aspiration (in chest X ray) at 12hours after intubation.
|
a.10min
b.12hours |
|
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Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
07/07/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The antrum and body of the stomach can be assessed sonographically to determine the kind and amount of gastric content (gas, fluid, or solid).The gastric antrum provides the most accurate quantitative data on the gastric volume. The antral cross-sectional area showed a nearly linear correlation with contents of up to 300 ml especially, in the right lateral decubitus position. Based on the facts that the predetermined fasting intervals in TBI patients is unreliable and it is possible to identify and measure gastric volume with USG, we hypothesize that POCUS will aid in the identification of decreased gastric emptying and risk of aspiration during induction of anaesthesia. Consequently, we plan to conduct a prospective observational study to evaluate the incidence of delayed gastric emptying and residual gastric volume in patients with isolated TBI undergoing emergency neurosurgery under general anaesthesia. In addition elevated ICP can also detected by measuring Optic nerve sheath diameter (ONSD) using 2D-USG. The intracranial subarachnoid space extends to and around the optic nerve. Hence, any changes in ICP will be reflected around the optic nerve as well. The measurement of Optic nerve sheath diameter(ONSD) using POCUS is one such promising modality supported by the literature. Methodology: After getting approval from Institute Ethics Committee (IEC), followed by trial registration with the Clinical Trials Registry of India (CTRI) patients will be enrolled in the study. All patients with isolated moderate (GCS≤12) to severe (GCS≤8) TBI scheduled for neurosurgery under general anaesthesia will be evaluated for inclusion and exclusion criteria and if found suitable, will be enrolled in the study. A written informed consent will be obtained from the legal heir of the patient. In the preoperative area, demographic data of the patient which include age, gender, approximate height and weight and BMI, existing comorbidities, details about the injury and its diagnosis, time and duration after which the patient is presenting for surgery, fasting time, last meal taken before the injury, and GCS will be noted. USG of stomach optic nerve sheath will be carried out: A) USG assessment of gastric antral content (empty, fluid, solid). B) USG assessment of gastric antral volume. C) USG assessment of ONSD will be performed as an indirect measurement of ICP. |