| CTRI Number |
CTRI/2013/05/003652 [Registered on: 20/05/2013] Trial Registered Retrospectively |
| Last Modified On: |
30/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Insertion of gastric tube before or after airway tube under general anaesthesia. |
|
Scientific Title of Study
|
Ease of nasogastric tube insertion before or after endotracheal intubation. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sameer Desai |
| Designation |
Assistant Professor |
| Affiliation |
SDM College of Medical Scieneces and Hospital |
| Address |
Dept of Anaesthesiology
SDM college of Medical Sceinces and Hospital,
Sattur
Dharwad
SDM college of Medical Sceinces and Hospital,
Sattur
Dharwar
580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9480752566 |
| Fax |
|
| Email |
sameeranaes@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Desai |
| Designation |
Assistant Professor |
| Affiliation |
SDM College of Medical Scieneces and Hospital |
| Address |
Dept of Anaesthesiology
SDM college of Medical Sceinces and Hospital,
Sattur
Dharwad
SDM college of Medical Sceinces and Hospital,
Sattur
Dharwar
580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9480752566 |
| Fax |
|
| Email |
sameeranaes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sameer Desai |
| Designation |
Assistant Professor |
| Affiliation |
SDM College of Medical Scieneces and Hospital |
| Address |
Dept of Anaesthesiology
SDM college of Medical Sceinces and Hospital,
Sattur
Dharwad
SDM college of Medical Sceinces and Hospital,
Sattur
Dharwar
580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9480752566 |
| Fax |
|
| Email |
sameeranaes@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept Anaesthesia
SDM College of Medical Sciences and Hospital
Sattur
Darwad. |
|
|
Primary Sponsor
|
| Name |
SDM College of Medical Sciences |
| Address |
Dept Anaesthesia
SDM College of Medical Sciences and Hospital
Sattur
Darwad. |
| Type of Sponsor |
Private 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 Sameer Desai |
Dept Anaesthesia |
Dept Anaesthesia
SDM College of Medical Sciences and Hospital
Sattur
Darwad.
Dharwad
KARNATAKA |
9480752566
sameeranaes@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients needing general anaesthesia with endotracheal intubation and who require NG tube insertion , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NG tube insertion after endotracheal intubation |
NG tube will inserted after orotracheal intubation. |
| Intervention |
NG tube insertion before endotracheal intubation |
NG tube will be inserted before orotracheal intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient receiving general anesthesia with endotracheal intubation for various surgical procedures
who need nasogastric (NG) tube insertion will be included in the study. |
|
| ExclusionCriteria |
| Details |
Predicted difficult airway/ intubation
Patient with full stomach, needing rapid sequence induction |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Success rate of first attempt of NG tube insertion
2. Number of attempts need for successful NG tube insertion. |
at the end of successful NG tube insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. time taken for successful NG tube insertion,
2. fall in the oxygen saturation more than 5percent
3. need for ventilation during the procedure,
4. complication like kinking, knotting, bleeding between the groups. |
Time in sec |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="124" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/10/2012 |
| Date of Study Completion (India) |
30/12/2014 |
| 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)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in European Journal of Anaesthesiology.
Deai SN, Torgal SV. Ease of insertion of nasogastric tube, before
or after endotracheal intubation under
general anaesthesia
A randomised study. Eur J Anaesthesiol 2016; 33:379–390 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Insertion of a Nasogastric tube (NGT) in anesthetised, paralysed,
and intubated patients can be difficult. Many techniques have been proposed to
aid in NGT insertion including forward displacement of the larynx, use of split
endotracheal tube, guidewire and neck flexion with lateral neck pressure. Despite of these
insertion of NGT under anaesthesia in presence of endotracheal tube is
difficult. Presence of endotracheal tube with
inflated cuff may change the anatomy of the oro and laryngo pharynx and hence
make the insertion of NGT difficult. Previous studies have recommended deflation of
endotracheal tube cuff to help insertion of NGT, to restore the anatomical distortion caused by endotracheal tube cuff. Whether general anaesthesia with muscle relaxtion per se makes the NGT insertion difficult or the inflated cuff of endotracheal tube hinders NGT is not studied. Therefore we are planing this study to check the ease of insertion of NGT before and after the endotracheal tube insertion. |