| CTRI Number |
CTRI/2021/03/031651 [Registered on: 02/03/2021] Trial Registered Prospectively |
| Last Modified On: |
01/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
"Comparison of three different methods of feeding tube placement in adult anaesthetised patients" |
|
Scientific Title of Study
|
"NASOGASTRIC TUBE INSERTION IN ANAESTHETISED ,INTUBATED ADULT PATIENTS- A COMPARISION
BETWEEN CONVENTIONAL METHOD,FROZEN METHOD AND REVERSE SELLICKS MANOEUVRE" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J BANDHAVYA |
| Designation |
Junior Resident |
| Affiliation |
Vijaynagar Institute of Medical Sciences Bellary |
| Address |
2nd year post graduate Department of Anaesthesiology VIMS Ballari
2nd year post graduate Department of Anaesthesiology VIMS Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9632699466 |
| Fax |
|
| Email |
bandhavya21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J BANDHAVYA |
| Designation |
Junior Resident |
| Affiliation |
Vijaynagar Institute of Medical Sciences Bellary |
| Address |
2nd year post graduate Department of Anaesthesiology VIMS Ballari
2nd year post graduate Department of Anaesthesiology VIMS Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9632699466 |
| Fax |
|
| Email |
bandhavya21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Venkateshwar Rao |
| Designation |
Associate professor |
| Affiliation |
Vijaynagar Institute of Medical Sciences Bellary |
| Address |
Associate professor Department of Anaesthesiology VIMS Ballari
Associate professor Department of Anaesthesiology VIMS Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9845774121 |
| Fax |
|
| Email |
drraogv@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vijayanagara Institute of Medical Sciences |
| Address |
Cantonment road OPD Ballari |
| 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 J BANDHAVYA |
Vijayanagara Institute of Medical Sciences |
Major OT complex, Department of Anaesthesiology
Bellary
KARNATAKA |
9632699466
bandhavya21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vijayanagara Institute of Medical Sciences |
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 |
Nasogastric tube insertion
|
Frozen technique - naso-oral route
|
| Comparator Agent |
Nasogastric tube insertion |
Conventional nasogastric tube insertion-naso-oral route |
| Intervention |
Nasogastric tube insertion |
Reverse Sellicks manoeuvre- naso-oral route |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA physical status 1 and 2
2) Patients with normal cardiopulmonary function
3)Patients with normal airway (modified Mallmapatti class 1 or 2) |
|
| ExclusionCriteria |
| Details |
1) Refusal by patients for the procedure
2)Patients with upper respiratory tract infection,nasal mass,cleft lip or palate, significant deviated nasal septum.
3) Surgeries requiring nasal intubation
4) History of any uncontrolled bleeding diastheses or recent radiotherapy to head and neck, corrosive poisoning , esophageal stricture and varies
5) Patients with anticipated difficult airway |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Success rate of NG tube insertion
2)Number of attempts |
NGT insertion after intubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)The procedure time
2) Complications- bleeding,nasal trauma, aspiration. |
Till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Insertion of NGT is an essential procedure for several abdominal as well as thoracic surgeries.Conventional insertion of NGT in anaesthetised, paralyzed, intubated patient is often a difficult and more failure rate is noticed.Many modifications of conventional technique have been tried to facilitate the easy NGT insertion.Hence we are comparing three techniques of NGT insertion (conventional,frozen technique,reverse Sellick’s manoeuvre) with regard to the time consumption and reducing the injury during during the procedure like mucosal tear,nasal trauma, bleeding, aspiration risk etc. |