| CTRI Number |
CTRI/2024/04/065002 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Randomized comparative study |
| Study Design |
Other |
|
Public Title of Study
|
Gastric insufflation with supraglottic airway devices in patients undergoing laproscopic cholecystectomy
|
|
Scientific Title of Study
|
A randomized comparative study of gastric insufflation with Supraglottic
Airway Device and endotracheal tube using ultrasound in patients undergoing
laparoscopic cholecystectomy
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kuntla Suchitha |
| Designation |
Resident Anaesthesiology |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Department of Anaesthesiology, ABVIMS and Dr RML hospital,New Delhi
Central
DELHI
110001
India |
| Phone |
7773001083 |
| Fax |
|
| Email |
suchireddy2206@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namita Arora |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Room 304,Department of Anaesthesiology, ABVIMS and Dr RML hospital,New Delhi
Central
DELHI
110001
India |
| Phone |
9868219619 |
| Fax |
|
| Email |
drnamitaarora@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namita Arora |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Room 304,Department of Anaesthesiology, ABVIMS and Dr RML hospital,New Delhi
Central
DELHI
110001
India |
| Phone |
9868219619 |
| Fax |
|
| Email |
drnamitaarora@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room 304,Departement of anaesthesiology,ABVIMS AND DR RML HOSPITAL, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr RML Hospital |
| Address |
Room 304,Departement of anaesthesiology,ABVIMS and Dr RML,New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Suchitha Kuntla |
room 304,Departemnt of anaesthesiology,ABVIMS and Dr RML Hospital, New Delhi |
Room 304, Department of anaesthesiology,ABVIMS and Dr RML,New Delhi
Central
DELHI |
07773001083
suchireddy2206@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
gastric antral cross-section area |
comparison of ultrasound guided estimation of gastric antral ross sectional area in patients with supraglottic airway device and endotracheal tube |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1-2 patients |
|
| ExclusionCriteria |
| Details |
patients with GERD, patients who have previously undergone gastric surgery,pregnant women, BMI greater than 30kg/m2 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasound guided assessment of gastric antral cross sectional area |
before induction of anaesthesia, after airway insertion, before airway removal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.leak pressure by auscultation after insertion
2.EtCO2, Airway Pressure, SpO2 |
Throughout surgery |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| 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="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
|
Airway management in laparoscopic surgeries under General anesthesia is done by either endotracheal tubes or supraglottic airway devices. With supraglottic devices there is a theoretical risk of gas leak and gastric distention than can pose a risk of pulmonary aspiration of gastric contents. This is a randomized comparative study involving 144 patients undergoing laparoscopic cholecystectomy to compare gastric insufflation with supraglottic airway device and endotracheal tube by estimating gastric antral cross-sectional area using ultrasound and thus quantifying gastric insufflation with supraglottic airway devices in such patients. This will help us understand the risk of pulmonary aspiration with supraglottic airway devices in patients undergoing laparoscopic surgeries. |