| CTRI Number |
CTRI/2021/10/037136 [Registered on: 06/10/2021] Trial Registered Prospectively |
| Last Modified On: |
02/12/2022 |
| 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 Conventional Blind insertion technique and throat-pack in-situ technique |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRVASKAR ROY |
| Designation |
POST GRADUATE TRAINEE - ANAESTHESIOLOGY |
| Affiliation |
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH AND SSKM HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH AND SSKM HOSPITAL
A.J.C BOSE ROAD
KOLKATA
Kolkata
WEST BENGAL
700020
India |
| Phone |
|
| Fax |
|
| Email |
suryasilpi@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DRMOHANCHANDRA MANDAL |
| Designation |
PROFESSOR - DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH AND SSKM HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH AND SSKM HOSPITAL
A.J.C BOSE ROAD
KOLKATA
Kolkata
WEST BENGAL
700020
India |
| Phone |
|
| Fax |
|
| Email |
drmcmandal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRMOHANCHANDRA MANDAL |
| Designation |
PROFESSOR - DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH AND SSKM HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH AND SSKM HOSPITAL
A.J.C BOSE ROAD
KOLKATA
Kolkata
WEST BENGAL
700020
India |
| Phone |
|
| Fax |
|
| Email |
drmcmandal@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIA
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH AND SSKM HOSPITAL
KOLKATA |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Institute of Post Graduate Medical Education and Research,244 A.J.C Bose Road
KOLKATA
PIN 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 |
| DRVASKAR ROY |
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH AND SSKM HOSPITAL |
Department of Anaesthesiology
3rd Floor,Main Block
244,A.J.C Bose Road
Kolkata - 20
Kolkata
WEST BENGAL |
9433485285
suryasilpi@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME and 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 |
Conventional Blind insertion technique |
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 within one year period |
| Intervention |
Throat-pack in-situ technique |
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 within one year period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status I and II
2. Aged between 18 to 65 years |
|
| ExclusionCriteria |
| Details |
1. Nasal mass
2. Uncontrolled bleeding diatheses
3. Significant deviated nasal septum
4. Oesophageal stricture
5.History of corrosive poisoning
6.Oesophageal varices
7.Those patients requiring NGT insertion in the pre-induction phase |
|
|
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 ofnasogastric 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="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2021 |
| Date of Study Completion (India) |
06/09/2022 |
| 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
Modification(s)
|
Successful placement of nasogastric tube (NGT) in anaesthetised patients in operating room appears to be challenging one compared with its insertion in awake patients owing to the lack of patient’s cooperation in the former.The tube could undergo coiling,kinking in the oropharynx or get impacted in the pyriform fossa. In this study,a comparison was made between the Conventional Blind insertion technique and ’Throat-pack in-situ’ technique for NGT placement in terms of ’success rate in the first attempt’(Primary outcome),procedure time and incidence of adverse events. |