| CTRI Number |
CTRI/2023/09/058012 [Registered on: 26/09/2023] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to compare the various techniques of nasogastric tube insertion in anaesthetised, intubated patients |
|
Scientific Title of Study
|
Comparison of different techniques of nasogastric tube insertion in anaesthetised, intubated patients in terms of rate of success, time taken and complications: An observational study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Rashmi R |
| Designation |
Student |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Anaesthesia and Operation Theatre Technology
Program, MCHP,
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9611104572 |
| Fax |
|
| Email |
rashmirsalian@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka G Kini |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Hospital, Manipal |
| Address |
Department Of Anaesthesiology, Kasturba Medical
College and Hospital, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845801588 |
| Fax |
|
| Email |
piyu.pu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Kajal R Shetty |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Anaesthesia and Operation Theatre Technology
Program, MCHP,
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8073814280 |
| Fax |
|
| Email |
kajalshetty98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Manipal-576104, Udupi, Karnataka state, India
|
| Manipal College Of Health Professions, MAHE, Manipal-576104, Udupi, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Ms. Rashmi R |
| Address |
Manipal College Of Health Professions, MAHE, Manipal |
| 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 |
| Ms Rashmi R |
Kasturba Medical College and Hospital, Manipal |
Department of
Anaesthesiology
Pre Anaesthesia ward,
Operating room,
Operation Theatre Complex
Udupi
KARNATAKA |
9611104572
rashmirsalian@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research) |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants above 18 years of age
undergoing surgeries under general
anaesthesia requiring
NGT insertion
2. Both male and female participants
3. Participants with ASA grading of I, II
or III
|
|
| ExclusionCriteria |
| Details |
1. Esophageal disorders
2. Nasal mass or nasal obstruction
3. Upper respiratory tract deformities
4. Bleeding disorders, patients on
anticoagulants
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Successful placement of NGT |
can be assessed from inserting the tube through the either nostril and getting a confirmation by hearing the gurgling sounds by auscultation over the epigastrium which can take upto 1 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration- Time taken for the entire procedure of tube insertion & the confirmation of tube placement |
Which can take upto a total of 1-2 minutes |
Complications-
several attempts of the tube insertion may lead to some complications such as Kinking, coiling of the tube, mucosal bleeding |
complication such as mucosal bleeding which can treated by applying nasal drops & gently pressing the nostril for few seconds & assessed between 1-2 minutes of the procedure |
|
|
Target Sample Size
|
Total Sample Size="215"
Sample Size from India="215"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="239" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/10/2023 |
| Date of Study Completion (India) |
31/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This is a cross-sectional study titled Comparison of different techniques of nasogastric tube insertion in anaesthetised, intubated patients in terms of rate of success, time taken and complications: An observational study. Patients above 18 years of age with ASA Physical Status grading of I, II or III undergoing surgeries under general anaesthesia requiring NGT insertion will be recruited. The primary objective of the study is to analyse the commonest technique of NGT insertion among participants based on the first attempt success rate, number of attempts and time taken for insertion of NGT and the secondary objective is to observe for any complications and the technique of confirming proper NGT placement. |