| CTRI Number |
CTRI/2020/09/027810 [Registered on: 15/09/2020] Trial Registered Prospectively |
| Last Modified On: |
10/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of intubating bougie or stylet with reinforced endotracheal tube using Airtraq Videolaryngoscope |
|
Scientific Title of Study
|
Role of intubating bougie or stylet for ease of intubation with reinforced endotracheal tube using Airtraq videolaryngoscope |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Theresa kikon |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical college |
| Address |
Department of Anaesthesiology Maulana azad medical college and associated lol nayak Hospital.
Bahadur Shah Zafar Marg
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9958731868 |
| Fax |
|
| Email |
Theresa.kikon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Wadhawan |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of anaesthesiology and intensive care. Maulana Azad medical college, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604218 |
| Fax |
|
| Email |
Soniawadhawan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Theresa Kikon |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad medical college |
| Address |
Dept of Anaesthesiology. Maulana Azad medical college. Bahadur shah Zafar Marg. New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9958731868 |
| Fax |
|
| Email |
Theresa.kikon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad medical college, Bahadur shah Zafar Marg. 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadur shah Zafar Marg
New Delhi 110002 |
| 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 |
| Theresa kikon |
Maulana Azad medical college |
Department of Anaesthesiology
Maulana Azad medical college
New Delhi
DELHI |
9958731868
Theresa.kikon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Maulana Azad medical college |
Approved |
| Maulana Azad medical college |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Modified Mallampati Class 1 and 2
2. BMI less or equal to 30kg/m2 |
|
| ExclusionCriteria |
| Details |
1.Mouth opening less than or equal to 2.5cm
2.Oral cavity pathology
3.limited neck mobility(cervical spine injury/PBC neck/ Neck mass)
4. Pregnant patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intubation success rate |
90 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time taken for intubation
2. Number of manoeuvre
3.Changes in hemodynamic parameters
4. Incidence of complications |
hemodynamic parameters will be noted at 2 min interval for first 10 mins after intubation |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
21/09/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Airtraq is a channelled videolaryngoscope that facilitates tracheal intubation in normal and difficult airways. The manufacturers recommend the use of appropriate sized endotracheal tube(ETT) for Airtraq laryngoscope assisted intubation, but there is no specific recommendations on appropriate type of ETT. The reinforced tube ETT is flexible so it is difficult to guide the tube correctly through the channel of the Airtraq. A stylet is used to give firmness to the reinforced ETT however this may affect the ease of intubation through the Airtraq. Intubating bougie is a routinely used adjunct for facilitating endotracheal intubation in difficult airways and is atraumatic. Hence we would like to conduct a study to assess the appropriate method for successful Airtraq guided intubation using reinforced endotracheal tube. |