| CTRI Number |
CTRI/2024/07/071245 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the first attempt success rate of pre-shaped bougie with stylet for insertion of airway tube in trachea with special blade( C-MAC D Blade) of videolaryngoscope in patients posted for elective surgery by head held in neutral position. |
|
Scientific Title of Study
|
Comparison between pre-shaped bougie versus stylet used for intubation with C-MAC D-blade videolaryngoscope in simulated difficult airway:A randomised control 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 |
Lavanya ruba malini |
| Designation |
Junior Resident |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Anaesthesiology,
OT Complex,
IPD Building,
5TH Floor,
AIIMS Patna,
Phulwarisharif,
Patna.
Patna BIHAR 801507 India |
| Phone |
7762897656 |
| Fax |
|
| Email |
lavanyadharmar98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr kunal singh |
| Designation |
Additional Professor |
| Affiliation |
AIIMS PATNA |
| Address |
room no 501,
Department of Anaesthesiology,
OT Complex,
IPD Building,
5TH Floor,
AIIMS Patna,
Phulwarisharif,
Patna.
Patna BIHAR 801507 India |
| Phone |
9411514945 |
| Fax |
|
| Email |
drsinghkunal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr kunal singh |
| Designation |
Additional Professor |
| Affiliation |
AIIMS PATNA |
| Address |
room no 501,
Department of Anaesthesiology,
OT Complex,
IPD Building,
5TH Floor,
AIIMS Patna,
Phulwarisharif,
Patna.
Patna BIHAR 801507 India |
| Phone |
9411514945 |
| Fax |
|
| Email |
drsinghkunal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,All India Institute of Medical sciences,Patna,Phulwari sharif, PIN-801507 |
|
|
Primary Sponsor
|
| Name |
All india institute of medical sciences,Patna |
| Address |
Department of Anaesthesiology,
OT Complex,5th floor,IPD Building,AIIMS Patna,Phulwarisharif,Patna,Bihar,Pin:801507,India |
| 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 Lavanya ruba malini |
All India Institute of Medical Sciences ,Patna |
Department of Anaesthesiology,
OT,
OT Complex,
5th floor,IPD Building,
Patna,
Bihar.
Patna BIHAR |
7762897656
lavanyadharmar98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Patna |
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 |
pre-shaped bougie |
General anaesthesia will be induced by Inj.Fentanyl 2mcg/kg, Inj.Propofol 2 to 2.5mg/kg and after checking ventilation Inj.Atracurium o.5mg/kg will be adminstered.Patients will be held in manual in line stabilisation.Laryngoscopy will be done by C-MAC D-blade videolaryngoscope and then pre-shaped bougie will be used for endotracheal tube placement not exceeding 60 seconds. Endotracheal tube placement will be confirmed by capnography. |
| Comparator Agent |
stylet |
General anaesthesia will be induced by Inj.Fentanyl 2mcg/kg, Inj.Propofol 2 to 2.5mg/kg and after checking ventilation Inj.Atracurium o.5mg /kg will be adminstered.Patients will be held in manual in line stabilisation.Laryngoscopy will be done by C-MAC D-blade videolaryngoscope and then stylet will be used for endotracheal tube placement not exceeding 60 seconds. Endotracheal tube placement will be confirmed by capnography. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients planned for elective surgeries under GA
ASA 1 and 2
BMI:18-35 |
|
| ExclusionCriteria |
| Details |
ASA 3 and 4
BMI more than 35
Pregnant women
Increased risk of regurgitation and aspiration of gastric contents
Previous upper gastrointestinal surgery
History of coagulopathy or anticoagulant use
cardiorespiratory or cerebrovascular disease
cervical spine pathology
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the successful intubation on the first attempt achieved with pre-shaped bougie or stylet as adjuncts to the C-MAC D-blade videolaryngoscope in a simulated difficult airway |
From insertion of C-MAC D-blade till the conformation of endotracheal tube, not exceeding 60 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Modified intubation difficulty score will be assessed.
To evaluate the time taken with pre-shaped bougie & stylet in intubation with C-MAC D-blade videolaryngoscope,
To check cormack-lehane grading.
To assess the hemodynamics response. |
To evaluate the time duration from insertion of C-MAC D-blade till conformation of endotracheal tube , not exceeding 60 seconds. |
|
|
Target Sample Size
|
Total Sample Size="170" Sample Size from India="170"
Final Enrollment numbers achieved (Total)= "170"
Final Enrollment numbers achieved (India)="170" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/08/2024 |
| Date of Study Completion (India) |
31/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" 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
|
Healthcare professionals encounter substantial difficulties when dealing with intubating patients with a challenging airway condition.This complexity arises from a variety of factors such as anatomical irregularities, limited mouth opening or distorted airway structures all of which obstruct a clear view and hinder tracheal access during intubation. For critically ill adults undergoing emergency tracheal intubation, failure to intubate the trachea on the first attempt occurs in upto 20% of the cases and is associated with severe hypoxemia and cardiac arrest. Videolaryngoscope has emerged as a vital method for this purpose, offering a clearer view of laryngeal inlet. However, even with this improved visibility, successfully guiding the tube into the trachea remains persistent challenge. Adjucts like bougie and stylet are used in conjunction with video laryngoscopes to enhance the success rate.This study aims to evaluate and compare the effectiveness of using pre-shaped bougie and stylet as adjuncts with C-MAC D-Blade video laryngoscope in achieving successful intubation in simulated difficult airway. The number of attempts taken to intubate weighs heavily on the patient outcome. Hence,we would like to take this study and find out whether pre-shaped bougie increase the incidence of successful intubation on first attempt in simulated difficult airway. |