| CTRI Number |
CTRI/2023/05/052290 [Registered on: 04/05/2023] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| 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 methods of nasogastric tube insertion in adult patients undergoing
surgery under general Anesthesia. |
|
Scientific Title of Study
|
Nasogastric tube insertion in anesthetized, intubated adult
patients: A comparison between combined lateral position with throat pack in-situ and
lateral position 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 RAJDEEP BISWAS |
| Designation |
Post Graduate Trainee, Anesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research |
| Address |
Institute of Post Graduate Medical Education and Research,
Department of Anesthesiology, 244 AJC Bose Road, Kolkata -
700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
8335820292 |
| Fax |
|
| Email |
rajdeepbiswas14091994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MOHANCHANDRA MANDAL |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research |
| Address |
Institute of Post Graduate Medical Education and Research,
Department of Anesthesiology, 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 Anesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research |
| Address |
Institute of Post Graduate Medical Education and Research,
Department of Anesthesiology, 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 Anesthesiology, Institute of Post Graduate Medical Education and Research,
Kolkata |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology |
| 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 RAJDEEP BISWAS |
Institute of Post Graduate Medical Education and Research and SSKM Hospital |
Department of Anesthesiology, 3rd floor, Main Block, 244 AJC Bose Road, Kolkata - 700020
Kolkata
WEST BENGAL |
8335820292
rajdeepbiswas14091994@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 |
| Intervention |
Insertion of nasogastric tube in lateral position 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 anesthetized
intubated adult patient. |
| Comparator Agent |
Insertion of nasogastric tube in lateral position. |
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 anesthetized intubated adult patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult (18 years and above) patients scheduled for abdominal surgeries and
requiring intraoperative 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.Patients with oral, nasal, pharyngeal or esophageal masses.
3. Patients with significant injuries involving the 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 (procedure time) for Successful insertion of
nasogastric tube.
2. Adverse events during the procedure like tube
kinking, coiling, Blood pressure and Heart
rate changes etc. |
Intra operative period (initial stage) |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="160" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/05/2023 |
| Date of Study Completion (India) |
18/04/2024 |
| 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 insertion of nasogastric tube (NGT) can be a challenging
procedure in anesthetized and intubated patients owing to absence of coordinated
swallowing effort. In this study, a comparison will be made between the technique of
“Combined lateral position with throat pack in-situ†or “lateral position alone†in
anesthetized, intubated, adult patients for NGT placement in terms of ‘success rate in the
first attempt’ (Primary outcome), procedure time and incidence of adverse events. |