| CTRI Number |
CTRI/2025/12/099339 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
27/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
comparison of three technique of nasogastric tube insertion |
|
Scientific Title of Study
|
Comparison of three techniques of nasogastric tube
insertion in anaesthetised, intubated patients for cardiac surgery: A randomized controlled trial
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sravan Kumar Jamalpur |
| Designation |
PG student |
| Affiliation |
B J Medical College |
| Address |
Department of Cardiac Anesthesia, U N Mehta Institute Of Cardiology and Research Center, New Civil hospital campus, Asarwa, Ahmedabad
Civil hospital campus Asarwa Ahmedabad Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
9948373675 |
| Fax |
07922682092 |
| Email |
drjsrk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritesh Babulal Shah |
| Designation |
Professor |
| Affiliation |
B J Medical College |
| Address |
Department of Cardiac Anesthesia, U N Mehta Institute Of Cardiology and Research Center, New Civil hospital campus, Asarwa, Ahmedabad
New Civil hospital campus, Asarwa, Ahmedabad Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825184730 |
| Fax |
07922682092 |
| Email |
drritesh_shah1@yahoo.com.in |
|
Details of Contact Person
Public Query
|
| Name |
Sravan Kumar Jamalpur |
| Designation |
PG student |
| Affiliation |
B J Medical College |
| Address |
Department of Cardiac Anesthesia, U N Mehta Institute Of Cardiology and Research Center, New Civil hospital campus, Asarwa, Ahmedabad
New Civil hospital campus, Asarwa, Ahmedabad Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
9948373675 |
| Fax |
07922682092 |
| Email |
drjsrk@gmail.com |
|
|
Source of Monetary or Material Support
|
| U N Mehta Institute of Cardiology and Research Center, New civil hospital campus, Asarwa, Ahmedabad, Gujarat, India, 380016 |
|
|
Primary Sponsor
|
| Name |
U N Mehta Institute of Cardiology and Research Center |
| Address |
U N Mehta Institute of Cardiology and Research Center, New civil hospital campus, Asarwa, Ahmedabad, Gujarat, India, 380016 |
| 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 |
| Sravan Kumar Jamalpur |
U N Mehta Institute of Cardiology and Research Center |
Department of Cardiac Anesthesia, 8th floor, OT complex,
Ahmadabad
GUJARAT |
9948373675
07922682092
drjsrk@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee-UNMICRC |
Approved |
| Institutional Ethic Committee-UNMICRC |
Approved |
| Institutional Ethic Committee-UNMICRC |
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 |
To compare the haemodynamic effects of three methods of ryles tube insertion in patients undergoing CABG valvular surgeries and CABG and valve surgery. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The patients scheduled for elective surgery like CABG, CABG and Valvular heart surgery, requiring NGT insertion were recruited during preoperative evaluation.
Patients aged 20 and 70 years, (ASA) physical status class III and above
normal airway (Mallampati grade 1 or 2) |
|
| ExclusionCriteria |
| Details |
Significant deformities of chin, pharynx and/or larynx, base of skull lesion, upper airway lesion,
abnormal prothrombin time, activated partial thromboplastin time and platelet disorder,
oesophageal stenosis or varices
history of radiotherapy in the head and neck region. Informed consent was obtained from each willing patient after discussion of the study procedure and expected complications.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the haemodynamic effects of different techniques of ryle’s tube insertion |
Baseline, within 10 minutes after procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of attempts
Time for successful insertion
Complications like kinking, coiling, failure, bleeding
|
To compare the haemodynamic effects of different techniques of ryles tube insertion |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
29/12/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Insertion
of nasogastric tubes (NGTs) in anaesthetised, intubated patients is a routine
practice which is often difficult with a conventional method. Different
techniques of NGT insertion have been tried with varying degree of success.
Failure rate is as high as 50% in the first attempt with
conventional method. The
distal portion of NGT has multiple apertures , weakest part, making it
susceptible to kink, coil, and knot. Various modifications have been made for
insertion of ryle’s tube
in an anaesthetised and
intubated patient. Insertion of ryle’s tube
during cardiac surgeries may lead to haemodynamic instability and arrhythmias.
|