| CTRI Number |
CTRI/2021/04/033131 [Registered on: 26/04/2021] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Different methods of insertion of tube in stomach via nose |
|
Scientific Title of Study
|
Comparison of different methods of nasogastric tube insertion in anaesthetized and intubated patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prerana Nirav Shah |
| Designation |
proffesor (Additional) |
| Affiliation |
GSMC & KEMH |
| Address |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869117027 |
| Fax |
|
| Email |
pps@kem.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Yogita Ganesh Agrawal |
| Designation |
Resident |
| Affiliation |
GSMC & KEMH |
| Address |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7757960372 |
| Fax |
|
| Email |
yogitagrawal19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yogita Ganesh Agrawal |
| Designation |
Resident |
| Affiliation |
GSMC & KEMH |
| Address |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India
MAHARASHTRA
400012
India |
| Phone |
7757960372 |
| Fax |
|
| Email |
yogitagrawal19@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Source of Monetary or Material Support
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India |
|
|
Primary Sponsor
|
| Name |
GSMC KEMH |
| Address |
Source of Monetary or Material Support
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India |
| 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 |
| YOGITA GANESH AGRAWAL |
GSMC KEMH |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India
Mumbai
MAHARASHTRA |
7757960372
yogitagrawal19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IEC-III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional |
NGT placement will be carried out through selected nostril by putting the head in a neutral position. Insert NGT tip slowly into the patient’s nostril and advance it steadily in a downward direction, along the bottom of nasal passage, pointing downward in direction of the ear on the same side as the nostril. Continue to advance NGT until you reach the mark. |
| Intervention |
Neck flexion with lateral neck pressure |
NGT will be inserted till 10 cm with flexed neck then lateral neck pressure will be applied on the same side of selected nostril and then NGT will be advanced further |
| Intervention |
Preinserted NPA (nasopharyngeal airway) |
size of NPA will be selected according to nose-to-ear lobe distance (ranging from 6-9cm), NGT will be advanced through lubricated NPA which is inserted in the selected nostril after tracheal intubation in the same way as group C. After confirmation of correct placement of NGT, NPA will be withdrawn and by cutting longitudinally freed from NGT |
| Intervention |
Reverse Sellick s manoeuvre |
NGT insertion will be done in same way as of conventional just with anterior lifting of cricoid cartilage. Successful NGT placement will be confirmed by auscultation over epigastrium. A stethoscope is placed over the epigastrium to listen for a whoosh sound as 10-30ml of air is insufflated through the NG
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18-65 years.
2.NGT placement required for perioperative care in either elective or emergency surgeries.
|
|
| ExclusionCriteria |
| Details |
1.History of bleeding disorder.
2.If known preoperative narrowing of oesophageal lumen due to any reason making NGT insertion impossible
3.If preoperative existing NGT present.
4.Recent nasal surgery, nasal fracture or severe nasal obstruction.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare four methods of NGT insertion (i.e., Conventional, Reverse Sellick’s, Neck flexion with lateral pressure and preinserted nasopharyngeal airway) in increasing correct placement (within two attempts till confirmation by auscultation ) in anaesthetized and intubated patients. |
During insertion of NGT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Attempts required for successful insertion.
2.Time required during NGT placement.
3.Rescue method required (Laryngoscope and Magill’s forceps)
4.Incidence of various complications like coiling, knotting, kinking, epistaxis.
|
After insertion of NGT |
Attempts required for successful insertion
Time required during NGT placement
Rescue method required (Laryngoscpe and Magills forceps)
Incidence of various complications like coiling, knotting, kinking, epistaxis |
After insertion of NGT |
|
|
Target Sample Size
|
Total Sample Size="163"
Sample Size from India="163"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Nasogastric tube insertion (NGT) in anaesthetized
patient is often difficult due to various reasons. Anatomical, patient being
unconscious, coiling, kinking with that there are multiple complications
related to NGT insertion leading to many cathostropic sequele. So,
to avoid this complications and easy insertion many methods have been tried.
This study compares four different methods of NGT insertion to increase success
rate for correct placement of NGT with less complications. It compares
conventional method, neck flexion with lateral pressure, reverse Sellick’s
method and preinstalled nasopharyngeal airway for increasing success rate of
insertion of NGT correctly. |