| CTRI Number |
CTRI/2023/04/051419 [Registered on: 10/04/2023] Trial Registered Prospectively |
| Last Modified On: |
07/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of method of stomach drainage tube via nose in anaesthetised patients |
|
Scientific Title of Study
|
Nasogastric tube insertion in anaesthetised and intubated patients using Reverse Sellick’s manoeuvre and Lateral Head Position method – A Randomised Clinical Comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay Kumar |
| Designation |
Senior Specialist |
| Affiliation |
Deen Dayal Upadhyay Hospital |
| Address |
Dept Of Anaesthesiology, Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi Shahaed Mangal Pandey Marg, Hari Nagar, New Delhi. 110064
West
DELHI
110064
India |
| Phone |
9718990114 |
| Fax |
|
| Email |
ajayannu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Senior Specialist |
| Affiliation |
Deen Dayal Upadhyay Hospital |
| Address |
Dept Of Anaesthesiology, Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi Shahaed Mangal Pandey Marg, Hari Nagar, New Delhi. 110064
West
DELHI
110064
India |
| Phone |
9718990114 |
| Fax |
|
| Email |
ajayannu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Singhal |
| Designation |
Primary DNB |
| Affiliation |
Deen Dayal Upadhyay Hospital |
| Address |
Dept Of Anaesthesiology, Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi Shahaed Mangal Pandey Marg, Hari Nagar, New Delhi. 110064
West
DELHI
110064
India |
| Phone |
9053808955 |
| Fax |
|
| Email |
mohitsinghal12345@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Deen Dayal Upadhayay Hospital, Hari Nagar, New Delhi-110064 |
|
|
Primary Sponsor
|
| Name |
Deen Dayal Upadhayay Hospital |
| Address |
Department of Anaesthesiology Deen Dayal Upadhayay Hospital, Hari Nagar, New Delhi-110064 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ajay Kumar |
Deen Dayal Upadhayay Hospital, Delhi |
Dept of Anaesthesia (Main OT-1, Main OT-2, Emergency OT)
West
DELHI |
9718990114
ajayannu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instutional Ethical Committe Deen Dayal Upadhayay Hospital, Govt. of NCT of Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (2) ICD-10 Condition: K819||Cholecystitis, unspecified, (3) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), (4) ICD-10 Condition: K37||Unspecified appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nasogastric Tube insertion will be done in anaesthetised patients using conventional method. |
For comparison, we will use conventional method in which head will be kept in neutral position and no external laryngeal manipulation, no change in head position, no instrumental assistance will be done.
Time duration end point- At the point of confirmation of Nasogastric tube by auscultation. |
| Intervention |
Nasogastric Tube insertion will be done in anaesthetised patients using Reverse Sellicks manoeuver and Lateral Head Position method. |
After Induction of Anaesthesia NGT will be inserted using Reverse Sellick’s manoeuvre in which head of the patient will be in neutral position and cricoid cartilage of the patient will be displaced anteriorly to facilitate the nasogastric tube passage.
while in Lateral Head Position Method the head of the patient will be turned to selected lateral position and the nasogastric tube will be inserted from the selected nostril, without any further manoeuvres of the neck, chin, jaw, or larynx.
Time duration end point- At the point of confirmation of Nasogastric tube by auscultation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients of ASA I and II category undergoing surgery under GA with oro-tracheal intubation requiring Nasogastric tube insertion. |
|
| ExclusionCriteria |
| Details |
1.H/o of Head injury, Neck Trauma
2.k/c/o Coagulopathy
3.k/c/o Nasopharyngeal, esophageal pathology
4.Facial deformity
5.H/o Head & Neck Radiotherapy
6.On anti-coagulant drugs
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare the success rate of nasogastric tube insertion. |
At the time of Nasogastric tube insertion confirmation by auscultation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study and compare the following parameters
1.Ease of insertion
2.Time taken for insertion
3.Complications, if any. |
At the time of Nasogastric tube insertion confirmation by auscultation
|
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
10/04/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ajayannu@gmail.com].
- For how long will this data be available start date provided 24-02-2026 and end date provided 24-02-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective, randomized clinical
comparative study will be conducted after obtaining approval from Scientific
Research Committee and the Institutional Ethics Committee and written informed
consent of patients. One hundred and thirty-five patients fulfilling the
inclusion criteria, scheduled for surgery under general anaesthesia with
orotracheal intubation requiring NGT insertion will be enrolled in the study.
Patients will be allocated to one of the three study groups after
randomization. In Group C nasogastric tube is inserted with head
in neutral position, Group L patient head turned towards selected lateral
position and in Group S we lift the cricoid cartilage of the patient
anteriorly. The three will be compared with respect to rate of successful insertion,
time required for insertion, hemodynamic variables during the insertion and
complications if any. |