| CTRI Number |
CTRI/2024/03/063515 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Awake intubation with Video laryngoscope versus Flexible Bronchoscope in difficult airway- A Randomised Comparative Study |
|
Scientific Title of Study
|
Awake naso-tracheal intubation with Video laryngoscope versus Flexible Bronchoscope in anticipated difficult airway- A Randomised Comparative Study |
| 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 Apeksha Patwa |
| Designation |
Associate professor in Department of Anaesthesiology |
| Affiliation |
Government Medical College, Baroda |
| Address |
Associate Professor
Department of Anesthesia,
Government Medical College, Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9879540828 |
| Fax |
|
| Email |
patwaapeksha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apeksha Patwa |
| Designation |
Associate professor in Department of Anaesthesiology |
| Affiliation |
Government Medical College, Baroda |
| Address |
Associate Professor
Department of Anaesthesiology,
Government Medical College, Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9879540828 |
| Fax |
|
| Email |
patwaapeksha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apeksha Patwa |
| Designation |
Associate professor in Department of Anaesthesiology |
| Affiliation |
Government Medical College, Baroda |
| Address |
Associate Professor
Department of Anaesthesiology,
Government Medical College, Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9879540828 |
| Fax |
|
| Email |
patwaapeksha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College,Baroda |
|
|
Primary Sponsor
|
| Name |
Medical College Baroda |
| Address |
Medical College Baroda, Vinoda Bhave Road, Anandpura, Vadodara |
| 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 Pragati Patel |
SSG Hospital |
4th floor, OT Block,
Department of Surgery,
Baroda Medical College
Vadodara
GUJARAT |
9427692890
pragatipatel12894@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research Medical college and SSG hospital Baroda |
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 |
Awake naso-tracheal intubation with Flexible Bronchoscope |
Awake naso-tracheal intubation will be
done with Flexible Bronchoscope. With endotracheal
tube loaded over the bronchoscope, it is introduced
from one nostril. under vision of camera, visualize the
carina.
After visualizing carina, loaded ET will slide over the
bronchoscope to the trachea and tube is positioned 5 tracheal rings above the carina, the cuff will be inflated and
scope is withdrawn. Total duration of intubation will be measured. |
| Intervention |
King vision video laryngoscope |
Awake naso-tracheal intubation will be
done with King Vision Video laryngoscope.
Before the insertion of the endotracheal tube,
distance from tragus to alae of the nose will be
measure and introduce the endotracheal tube from
nostril up to that distance.
Now, video laryngoscope is advanced from the
centre of the tongue towards glottis by viewing on the
screen of the monitor so that it will barely lift the
epiglottis with the tip of the blade.
After we can see the vocal cords in the centre of the
video laryngoscope display, advance the ET tube
slowly and watch for the tip of the endotracheal tube.
If the endotracheal tube is not towards glottis, then
inflate the cuff of the endotracheal tube with
appropriate amount of air till tube tip will align with
glottic opening. Once the tip of the endotracheal tube
reaches up to the vocal cords, deflates the cuff and
advance the tube further.
Once tube insertion and cuff disappearance through
vocal cords is confirmed, stabilize the ET tube and
remove the Video laryngoscope from the mouth. Total duration of intubation will be measured
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who require oral ane maxillofacial surgery,oropharyngeal malignancy, plastic reconstruction after trauma or restricted cervical spine movement with any one criterion for anticipated difficult airway as mentioned
2. Age:18 to 70 years
3. Gender: Either gender
4. ASA I to III
5. Mouth opening between 1.5FB to 2 FB |
|
| ExclusionCriteria |
| Details |
1) Patients not willing for participation
2) Contraindication to naso-tracheal intubation
3) Pregnancy
4) Morbid obesity (BMI more than 40)
5) Pt have sensitivity to local anesthetic agents |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total Duration of Intubation: In both the groups, starting point will be introduction of scope or endotracheal tube from nostril till confirmation of placement of tube by capnography |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor Hemodynamic parameters |
1 min, 5 min, 10 min, 15 min |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
11/03/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The aim of our study is to compare video laryngoscope and flexible bronchoscope for awake naso-tracheal intubation in anticipated difficult airway.60 patients belonging to the age group 18 to 70 years with ASA I,II or III are randomly selected into two groups. In Group VL, awake intubation will be done with King Vision video laryngoscope and in Group FB, awake intubation will be done with Flexible Bronchoscope after giving airway block in both the groups. The primary objective is to compare total duration of intubation in both the groups. Number of attempts, Cough Score, Comfort Score and vital parameters are also noted among the two groups. The proposed advantage of our study is that video laryngoscope guided awake naso-tracheal intubation might be more convenient and less time consuming in anticipated difficult airway patients. |