| CTRI Number |
CTRI/2024/08/072311 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to comparatively evaluate the accuracy of gastric content volume estimation by ultrasonography and endoscopic suctioning in fasting patients. |
|
Scientific Title of Study
|
To evaluate the accuracy of gastric content volume estimation by ultrasonography in fasting patients. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suneet Kant Kathuria |
| Designation |
HOD , Professor Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines , Ludhiana 141001
Punjab
India
Ludhiana
PUNJAB
141001
India |
| Phone |
9814007622 |
| Fax |
|
| Email |
suneetkathuria@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ekta Dhamu |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines , Ludhiana 141001
Punjab
India
Ludhiana
PUNJAB
141001
India |
| Phone |
7889148514 |
| Fax |
|
| Email |
ekta.dhamu1416@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ekta Dhamu |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines , Ludhiana 141001
Punjab
India
Ludhiana
PUNJAB
141001
India |
| Phone |
7889148514 |
| Fax |
|
| Email |
ekta.dhamu1416@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical college and Hospital, Ludhiana, Punjab 141001 |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical college and Hospital |
| Address |
Tagore Nagar, Civil lines, Ludhiana. 141001 Punjab India |
| Type of Sponsor |
Private medical college |
|
|
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 Suneet Kant Kathuria |
Dayanand Medical college and Hospital |
Department of Anaesthesia Dayanand Medical College and Hospital Tagore Nagar, Civil Lines Ludhiana 141001 Ludhiana PUNJAB Ludhiana PUNJAB
Ludhiana
PUNJAB |
9814007622
suneetkathuria@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical committee, dayanand medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than 18 years.
2. Either Sex.
3. ASA I-IV.
4. Ability to understand the study procedures and provide informed consent.
5.Fasting as per ASA guidelines (2022-2023).
|
|
| ExclusionCriteria |
| Details |
1.Age less than 18 years.
2. Patients with difficulty in assessment by gastric ultrasonography.
3. Patient with upper gastrointestinal bleed.
4.Previous lower esophageal or gastric surgery.
5. Abnormal upper gastrointestinal anatomy e.g., hiatus hernia and gastric tumours etc
6. Gastric outlet obstruction.
7. Patient taking prokinetic drugs.
8. Refusal by patient.
9. Non fasting patients [not following ASA guidelines (2022-2023)].
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the accuracy of volume estimated by ultrasonography and its quantitative correlation with gastric contents suctioned via endoscopy. |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the residual gastric volume with the duration of fasting for liquids, semisolids & solids. |
6-8 hours |
|
|
Target Sample Size
|
Total Sample Size="315"
Sample Size from India="315"
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)
|
20/08/2024 |
| 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="6"
Days="29" |
|
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
|
Pulmonary aspiration of gastric contents is one of the most dreaded complications of anesthesia. It predisposes the patients to lethal consequences secondary to lung injury from aspirated particulate matter, acid, and bacteria. Aspiration pneumonitis or Mendelson’s syndrome is a condition that occurs as a result of aspiration of very acidic sterile gastric fluid of volume >25 ml and pH <2.5 . Hence, preoperative estimation of gastric content volume with ultrasound remains a very valuable asset in assessing and reducing the perioperative risk of pulmonary aspiration. A prospective, randomized, interventional study will be conducted on 315 ASA I-IV adult patients undergoing endoscopic procedures under mild sedation. Gastric content volume will be first assessed preoperatively with Gastric ultrasonography (GUS). Later, gastric contents will be suctioned by the endoscopist under direct vision. Data collected will be statistically correlated and analysed. Our aim of study and primary outcome will be to evaluate the accuracy of volume estimated by ultrasonography and its quantitative correlation with gastric contents suctioned via endoscopy. The secondary outcome will be to correlate the residual gastric volume with the duration of fasting for liquids, semisolids and solids.
|