| CTRI Number |
CTRI/2019/08/020676 [Registered on: 13/08/2019] Trial Registered Prospectively |
| Last Modified On: |
09/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare two techniques of local anaesthesia to airway by using either ultrasound assisted local anesthesia drug injection or nebulisation with local anesthesia drug, for inserting tracheal tube into airway in conscious patient |
|
Scientific Title of Study
|
A comparative evaluation between ultrasound guided airway nerve block and
ultrasonic nebulisation with lignocaine for awake fiberoptic intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jharana Mohanta |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of anesthesia
AIIMS Rishikesh
Virbhadra road
Rishikesh, Uttarakhand, India
Vasudev apartment, B-8
Gali no 2
Aambagh, Rishikesh
Uttarakhand, India
249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9650524150 |
| Fax |
|
| Email |
cooljharana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajit Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of anesthesia
AIIMS Rishikesh
Virbhadra road Uttarakhand India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8475000189 |
| Fax |
|
| Email |
ajitdr.ajit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajit Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of anesthesia
AIIMS Rishikesh
Virbhadra road,Rishikesh Uttarakhand, India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8475000189 |
| Fax |
|
| Email |
ajitdr.ajit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
AIIMS Rishikesh
Virbhadra road
Rishikesh
Uttaranchal |
|
|
Primary Sponsor
|
| Name |
Department of anesthesiology |
| Address |
Department of Anesthesiology
AIIMS Rishikesh
Virbhadra road
Rishikesh
Uttaranchal |
| 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 Jharana Mohanta |
AIIMS Rishikesh |
Department of Anesthesiology
AIIMS Rishikesh
Virbhadra road
Rishikesh
Uttaranchal
Dehradun
UTTARANCHAL |
9650524150
cooljharana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 |
Group 1 (LA) |
Nebulisation with 3ml of 4% lignocaine (127.8 mg) through oxygen tubing will be done for 15 mins. |
| Intervention |
Group 2 (UAB) |
Superior Laryngeal Nerve (SLN) block will be given by tracing the nerve bilaterally. with the help of ultrasonography using a linear probe. Intratracheal injection will be given through the Cricothyroid membrane. Under all aseptic precautions, 2ml of 2% lignocaine(41.6 mg) will be injected at the three sites (bilateral SLN block, intratracheal injection)-(total 127.8 mg). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Mallampati grade 3 & 4 or inter-incisor distance <2.5 cm
ASA grade 1,2,3
Patients having mouth opening < 3 fingers, patients with a short neck and long teeth, micrognathia, obesity and cellulitis of the tongue.
Large oropharyngeal tumors, obstructing laryngeal tumors, congenital and acquired maxillofacial deformities, ankylosis of the temporomandibular joints, fractures or ankylosing spondylitis of the cervical spine, and all patients with a history of previous intubation problems.
Trauma – facial lacerations/ fractures, cervical spine instability, upper airway lacerations etc. |
|
| ExclusionCriteria |
| Details |
Significant glottis and subglottic obstructions
Blood and secretions in oral cavity
Allergy to local anesthetics / ultrasound gel
Hemodynamic instability
Infection at local site
Previous neck surgery
Epileptics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Cough reflex
2. Gag reflex |
1. Cough reflex at a time point when fibreoptic bronchoscope is passing through pharynx, during awake intubation
2. Gag reflex at a time point when fibreoptic bronchoscope is passing through larynx, during awake intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate, blood pressure, partial pressure of oxygen saturation |
1. Pre-operatively at a time point 10 minutes before shifting to operation theatre
2. Maximum value attained while performing fiberoptic awake intubation
3. Immediately after intubation (placement of endotracheal tube into trachea)
4. 5 minutes after intubation
5. 15 minutes after intubation |
| Duration of intubation |
Time point from entry of fibreoptic bronchoscope through nose to the endotracheal tube placement, during awake intubation |
Facial grimace
|
At a time point when fiberoptic bronchoscope is
1. passing through nose
2. passing through pharynx
3. passing through larynx |
| Vocal cord visibility |
At a time point when fiberoptic bronchoscope is passing through vocal cord |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2019 |
| 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="6"
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)?
|
|
Brief Summary
|
To compare
efficacy between nebulized lignocaine and ultrasound
guided airway nerve blocks
for
awake fiberoptic intubation. To assess cough reflex and gag reflex
during awake fiberoptic
intubation
A prospective, randomized, observer
blinded study. Sample size - with confidence interval 95%, α is
0.05 , power
of 80%, β is 0.2,
60 patients are needed. A written informed consent.
Randomly assigned into 2 groups by using
sealed envelope technique.
Standard fasting
protocol and anti-aspiration prophylaxis.
GROUP 1 (LA) – NEBULISATION WITH 4ML OF
LIGNOCAINE 4%
GROUP 2 (UAB) – USG GUIDED AIRWAY NERVE BLOCK
– 2ml
of 2% lignocaine - B/L superior laryngeal nerve and
recurrent laryngeal nerve.
Confirmation of
the tube in the trachea by end-tidal capnography.
•Hemodynamic parameters,
such as systolic blood pressure (SBP), diastolic blood pressure (DBP), HR, SpO2 , ECG will be recorded as base line
in preoperative room. Then vitals will be recorded during FOB intubation, immediately after
intubation, 5 min, 15 min of intubation inside OT.
•Gag reflex, cough reflex, vocal cord
position will be noted during intubation |