| CTRI Number |
CTRI/2021/09/036172 [Registered on: 02/09/2021] Trial Registered Prospectively |
| Last Modified On: |
03/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two techniques of nasogastric tube insertion in adult patients undergoing operation under General Anaesthesia. |
|
Scientific Title of Study
|
Nasogastric tube insertion in anaesthetised, intubated, adult patients: A comparison between the ‘Reverse Sellick’s manoeuvre with Throat pack in-situ’ and Reverse Sellick’s manoeuvre alone |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MRINAL KANTI ROY |
| Designation |
Post Graduate Trainee Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research, Kolkata |
| Address |
Institute of Post Graduate Medical Education and Research, Department of Anaesthesiology, 244 AJC Bose Road, Kolkata - 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
8910972495 |
| Fax |
|
| Email |
roykanti.2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MOHANCHANDRA MANDAL |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research, Kolkata |
| Address |
Institute of Post Graduate Medical Education and Research, Department of Anaesthesiology, 244 AJC Bose Road, Kolkata - 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433072820 |
| Fax |
|
| Email |
drmcmandal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MOHANCHANDRA MANDAL |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research, Kolkata |
| Address |
Institute of Post Graduate Medical Education and Research, Department of Anaesthesiology, 244 AJC Bose Road, Kolkata - 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433072820 |
| Fax |
|
| Email |
drmcmandal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Institute of Post Graduate Medical Education and Research, kolkata |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Institute of Post Graduate Medical Education and Research, 244 AJC Bose Road, Kolkata - 700020 |
| Type of Sponsor |
Government 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 MRINAL KANTI ROY |
Institute of Post Graduate Medical Education and Research and SSKM Hospital |
Department of Anaesthesiology, 3rd floor, Main Block, 244 AJC Bose Road, Kolkata - 700020
Kolkata
WEST BENGAL |
8910972495
roykanti.2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
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 |
Reverse Sellicks Manoeuvre |
To determine the incidence of successful insertion of nasogastric tube along with the time taken and adverse events during the procedure using this method in a anaesthetised intubated adult patient |
| Intervention |
Reverse Sellicks Manoeuvre with Throat pack in-situ |
To determine the incidence of successful insertion of nasogastric tube along with the time taken and adverse events during the procedure using this method in a anaesthetised intubated adult patient |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients undergoing elective Abdominal Surgeries under General Anaesthesia that require intra-operative NGT insertion.
2. Patients who have given written, informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Anatomical/Structural abnormalities such as gross deviated nasal septum, abnormalities involving lip and palate, etc
2. Patient with oral, Nasal, pharyngeal or esophageal masses.
3. Patient with significant injuries involving head and neck.
4. Patients with thrombocytopenia or coagulopathies. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Successful insertion of nasogastric tube in First attempt |
Intra operative period (initial stage) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time taken for Successful insertion of nasogastric tube
2. Adverse events during the procedure like tube kinking, coiling etc, Blood pressure and Heart Rate changes |
Intra operative period (initial stage) |
|
|
Target Sample Size
|
Total Sample Size="222"
Sample Size from India="222"
Final Enrollment numbers achieved (Total)= "222"
Final Enrollment numbers achieved (India)="222" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2021 |
| Date of Study Completion (India) |
16/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Successful placement of Nasogastric tube (NGT) in anaesthetised patients in operating room under General Anaesthesia appears to be challenging one compared with its insertion in awake patients owing to the lack of patients cooperation in the former. In this study, a comparison will be made between the Reverse Sellick’s Manoeuvre with Throat pack in situ and Reverse Sellick’s Manoeuvre alone for NGT placement in terms of Success in the first attempt, procedure time and incidence of adverse events. |