| CTRI Number |
CTRI/2020/08/027360 [Registered on: 26/08/2020] Trial Registered Prospectively |
| Last Modified On: |
21/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Ryles tube insertion in intubated patients: Comparison of three different positions;standard neck position , additional bending of neck and standard neck position with pressure applied to side of neck. |
|
Scientific Title of Study
|
Nasogastric tube insertion in intubated patients: Comparison of three different positions; Standard sniffing position, Additional flexion of neck and standard sniffing position with lateral neck pressure. |
| Trial Acronym |
NGT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MADHU GUPTA |
| Designation |
HOD(ADMINISTRATIVE),DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
ESI PGIMSR Basaidarapur |
| Address |
ESI-PGIMSR MODEL HOSPITAL , BASAIDARAPUR ,NEW DELHI
WEST DELHI
110015
INDIA
Ring Rd,Block W,Basai Dara pur, Bali Nagar,New Delhi 110015
South West
DELHI
110015
India |
| Phone |
9873581030 |
| Fax |
|
| Email |
madhugupta2602@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MADHU GUPTA |
| Designation |
HOD(ADMINISTRATIVE),DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
ESI PGIMSR Basaidarapur |
| Address |
ESI-PGIMSR MODEL HOSPITAL , BASAIDARAPUR ,NEW DELHI
WEST DELHI
110015
INDIA
Ring Rd,Block W,Basai Dara pur, Bali Nagar,New Delhi 110015
South West
DELHI
110015
India |
| Phone |
9873581030 |
| Fax |
|
| Email |
madhugupta2602@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHYAM MOHANAN |
| Designation |
PG JUNIOR RESIDENT |
| Affiliation |
ESI PGIMSR Basaidarapur |
| Address |
ESI-PGIMSR MODEL HOSPITAL,NEW DELHI
WEST DELHI
110015
Ring Rd,Block W,Basai Dara pur, Bali Nagar,New Delhi 110015
West
DELHI
110015
India |
| Phone |
9526624312 |
| Fax |
|
| Email |
shyamfrisbeez@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI PGIMSR MODEL HOSPITAL BASAIDARAPUR |
|
|
Primary Sponsor
|
| Name |
ESI PGIMSR |
| Address |
ESIC HOSPITAL
Ring Rd,Block W, Basai Dara Pur,Bali Nagar, New Delhi 110015 |
| 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 MADHU GUPTA |
ESI PGIMSR |
ESIC Hospital ,Department of Anaesthesia , 3rd floor OT complex ,basaidarapur
Basaidarapur, Bali Nagar, New Delhi 110015
West
DELHI |
9873581030
madhugupta2602@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nasogastric tube insertion in intubated patients: comparison in three different positions;standard sniffing position, additional flexion of neck and standard sniffing position with lateral neck pressure. |
Nasogastric tube insertion in intubated patients: comparison in three different positions;standard sniffing position, additional flexion of neck and standard sniffing position with lateral neck pressure.
The correct placement of nasogastric tube will be confirmed by auscultation in the epigastrium by whoosh test.
If unable to insert in the first attempt the tube will be withdrawn completely and cleaned.Then NGT will be relubricated and re inserted in the same nostril and advanced further by same technique.
If NGT insertion is not possible in 2 attempts the technique will be considered as failure. |
| Intervention |
Prospective and interventional randomized comparative study |
Nasogastric tube insertion in intubated patients: comparison in three different positions; standard sniffing position, additional flexion of neck and standard sniffing position with lateral neck pressure.
The correct placement of nasogastric tube will be confirmed by auscultation in the epigastrium by whoosh test.
If unable to insert in the first attempt the tube will be withdrawn completely and cleaned.Then NGT will be relubricated and re inserted in the same nostril and advanced further by same technique.
If NGT insertion is not possible in 2 attempts the technique will be considered as failure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Scheduled for elective surgery under general anaesthesia requiring nasogastric tube insertion.
ASA physical status I and II |
|
| ExclusionCriteria |
| Details |
Patients with
- Airway distortion or trauma
- Facial distortion
- cervical spine pathology
- patients on aspirin or anticoagulants
- gastroesophageal reflux disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of attempts taken for successful placement of nasogastric tube confirmed by whoosh test |
less than 2 attempts
equal to 2 attempts
more than 2 attempts |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Time taken for insertion of nasogastric tube.
2) Occurence of complications like bleeding ,coiling etc. |
less than 2 attempts
equal to 2 attempts
more than 2 attempts |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
30/08/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study we aim to compare the success of insertion of nasogastric tube in first attempt in intubated patients in standard sniffing position, additional flexion of neck and standard sniffing position with lateral neck pressure. There is a difference in first pass success rate of insertion of nasogastric tube in intubated patients with all the three different positions i.e standard sniffing position,additional flexion of neck and standard sniffing position with lateral neck pressure.
|