| CTRI Number |
CTRI/2024/04/065739 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between the performance of two methods of nasogastric tube insertion in adult patients undergoing surgery under general Anesthesia. |
|
Scientific Title of Study
|
Comparison between Tuoren Video laryngoscope-guided technique and Blind method for nasogastric tube placement in anasesthetised,intubated,adult patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rimpi Aich |
| Designation |
Post Graduate Trainee,Anesthesiology |
| Affiliation |
|
| Address |
Institute of Post Graduate Medical Education and Research,
Department of Anaesthesiology,
244 AJC Bose Road,
kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9614192145 |
| Fax |
|
| Email |
rimpiaich5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MOHANCHANDRA MANDAL |
| Designation |
Professor,Department of Anesthesiology |
| Affiliation |
|
| Address |
Institute of Post Graduate Medical Education and Research,
Department of Anaesthesiology,
244 AJC Bose Road,
kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433072820 |
| Fax |
|
| Email |
drmcmandal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MOHANCHANDRA MANDAL |
| Designation |
Professor,Department of Anesthesiology |
| Affiliation |
|
| Address |
Institute of Post Graduate Medical Education and Research,
Department of Anaesthesiology,
244 AJC Bose Road,
kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433072820 |
| Fax |
|
| Email |
drmcmandal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,
3rd floor,Main block,
Institute of Post Graduate Medical Education and Research,
244 AJC Bose road,
Kolkata-700020
kolkata,
West Bengal,
India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Institute of Post Graduate Medical Education and Research,
244 AJC Bose Road,
Kolkata-700020,
West Bengal,
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 |
| Dr Rimpi Aich |
Institute of Post Graduate Medical Education and Research and SSKM Hospital |
Department of
Anesthesiology, 3rd
floor, Main Block, 244
AJC Bose Road,
Kolkata - 700020
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
9614192145
rimpiaich5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
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 |
| Comparator Agent |
Insertion of nasogastric tube placement without any instrument blindly. |
To determine the procedure time of successful insertion of nasogastric tube without any assisted device or external laryngeal manipulation, along with the success rate and adverse events during the procedure in a anesthetized, intubated, adult patient. |
| Intervention |
Insertion of nasogastric tube using Tuoren Video laryngoscope |
To determine the procedure time of successful insertion of nasogastric tube guided by Tuoren video laryngoscope, along with the success rate and adverse events during the procedure in a anesthetized, intubated, adult patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult above 18 years patients undergoing elective abdominal surgeries that require intra operative nasogastric tube insertion.
2. Patients who have given written informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Anatomical/structural abnormalities such as gross deviated nasal septum, abnormality involving lips and palate.
2. Patients with oral ,nasal ,pharyngeal, oesophageal mass.
3. Patients with significant injuries involving head and neck.
4. Patients with thrombocytopenia or coagulation disorder.
5. Small mouth opening. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine and compare the procedure time of successful nasogastric tube insertion of both the techniques . |
Intra operative period(initial stage). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the proportion of the patients in whom successful nasogastric tube insertion will be possible within first attempt using either of the two methods.
2. To observe the adverse events ,if any. |
Intra operative period (initial stage) |
|
|
Target Sample Size
|
Total Sample Size="148"
Sample Size from India="148"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="148" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
22/04/2024 |
| Date of Study Completion (India) |
31/12/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Successful insertion of nasogastric tube placement can be challenging procedure in anesthetized and intubated patients compared to conscious patients due to absence of coordinated swallowing effort which leads to prolonged procedure time and repetitive attempts of insertion. This is also associated with kinking, misplacement and coiling of tube as well as some adverse effects like injury leading to bleeding. Many modification of the blind method have been developed to overcome the drawbacks and using instruments like video laryngoscope has the potential of having higher success rate over blind insertion owing to the advantage of detecting hindrance and necessary manipulation under vision. In this study a comparison will be made between the blind insertion and Tuoren Video laryngoscope guided insertion of nasogastric tube placement in anesthetized, intubated, adult patients in terms of procedure time (primary outcome), success rate in first attempt, and incidence of adverse events. |