| CTRI Number |
CTRI/2024/09/073731 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare flexitip with standard bougie for nasal intubation using videolaryngoscope in adult patients |
|
Scientific Title of Study
|
Comparative evaluation of flexitip and gum elastic bougie for nasotracheal intubation by Tascope in adult patients undergoing maxillofacial surgeries |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mamta Bhardwaj |
| Designation |
PROFESSOR |
| Affiliation |
Pt. B.D Sharma PGIMS Rohtak |
| Address |
department of anaesthesiology and critical care PGIMS ROHTAK
department of anaesthesiology and critical care PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9812789476 |
| Fax |
|
| Email |
drbmamta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mamta Bhardwaj |
| Designation |
PROFESSOR |
| Affiliation |
PGIMS ROHTAK |
| Address |
department of anaesthesiology PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9812789476 |
| Fax |
|
| Email |
DRBMAMTA@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
AVINASH PUNIA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMS ROHTAK |
| Address |
department of anaesthesiology PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9466587924 |
| Fax |
|
| Email |
AVINASHPUNIA1@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Department of Anaestesiology and Critical care PGIMS rohtak 124001 |
|
|
Primary Sponsor
|
| Name |
Pandit BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical care Modular OT cum ICU complex PGIMS Rohtak |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PGIMS ROHTAK |
DEPARTMENT OF ANAESTHESIOLOGY PGIMS ROHTAK |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MAMTA BHARDWAJ |
Pt BD Sharma PGIMS Rohtak |
MODULAR OT COMPLEX DEPARTMENT OF ANAESTHESIOLOGY
PGIMS ROHTAK
Rohtak
HARYANA |
9812789476
drbmamta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BREC ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FLEXITIP BOUGIE |
At the time of nasotracheal intubation flexitip bougie will be used as an adjunct for intubation. Success rate of intubation will be compared with the comparator.It may take around 5 minutes during intubation |
| Comparator Agent |
Gum elastic bougie |
At the time of intubation gum elastic bougie will be used as an adjunct for nasal intubation total time may take 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex with American Society of Anesthesiologists physical status I- II, aged between 18 and 65 years, scheduled to undergo elective maxillofacial surgery and needing nasal intubation under general anaesthesia will be enrolled. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria-
Patients with
1. Mouth opening less than 1.5 cm
2. Pregnancy
3. Coagulopathy or On Anticoagulants
4. Refusal to consent
5. Anticipated difficult mask ventilation
6. Requirement of nasotracheal tube number 6.5 or smaller
will be excluded from the study
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of first attempt intubation success rate between FTB and GEB (Standard Bougie )
|
5 minutes
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary
1. Time to insert bougie
2. Number of Intubation attempts
3. Time to intubation
4. Optimization maneuvers
5. Ease of use of bougie
6. Hemodynamic parameters
7. Traces of the blood on the tube or pharynx, if any will be noted
|
baseline 3 & 5 minutes |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
25/09/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title : Comaprative evaluation of gum elastic and flexitip bougie for nasotracheal intubation by Tascope in adult patients undergoing maxillofacial surgeries. A total Fifty two patients with 26 in each group of 18-65 years of age , ASA physical status I and II will be included, First attempt success rate, intubation time, hemodynamic parameters, optimization maneuvers, time to insert and ease of use of bougie, trauma to oropharyngeal structures etc will be noted |