| CTRI Number |
CTRI/2019/08/020551 [Registered on: 05/08/2019] Trial Registered Prospectively |
| Last Modified On: |
20/08/2021 |
| 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
|
Comparison of two different devices at the beginning of anaesthesia in awake adult population |
|
Scientific Title of Study
|
Comparison of C-MAC videolaryngoscope and flexible fiberoptic bronchoscope for awake endotracheal intubation in adult patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr NIMMA SURESH CHANDRA |
| Designation |
post graduation |
| Affiliation |
Maulana Azad medical college |
| Address |
Department of anaesthesiology and intensive care, BL Taneja block,Lok Nayak hospital
New Delhi
DELHI
110002
India |
| Phone |
9502240042 |
| Fax |
|
| Email |
chandra.chintu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr poonam bhadoria |
| Designation |
Director professor |
| Affiliation |
Maulana azad medical college |
| Address |
Department of Anaesthesiology and critical care, BL Taneja block, lok nayak hospital
New Delhi
DELHI
110002
India |
| Phone |
9968604213 |
| Fax |
|
| Email |
bhadoriap@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr poonam bhadoria |
| Designation |
Director professor |
| Affiliation |
Maulana azad medical college |
| Address |
Department of Anaesthesiology and critical care, BL Taneja block, lok nayak hospital
New Delhi
DELHI
110002
India |
| Phone |
9968604213 |
| Fax |
|
| Email |
bhadoriap@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and critical care
maulana azad medical college and Lok nayak hospital
new delhi
110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical college |
| Address |
maulana azad medical college
Lok nayak hospital
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 |
| Nimma Suresh chandra |
Lok Nayak Hospital |
Department of anaesthesia
Maulana Azad medical college
New Delhi
110002
New Delhi
DELHI |
9502240042
chandra.chintu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients posted for elective surgery under general anaesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endotracheal intubation in awake adult population with C-MAC video laryngoscope and Fiberoptic Bronchoscope |
After adequate NPO, premedication and preparing patient airway for awake intubation, patient will be shifted in operation theater.After attaching ASA standard monitors patient intubated either by C-MAC video laryngoscope or Fiberoptic Bronchoscope and then induction agents are administered |
| Comparator Agent |
Time taken for intubation, rate of successful tracheal intubation,haemodynamic variations and complications |
Time taken for the intubation will be the primary outcome. The haemodynamic variations will be recorded for every one minute till ten minutes after intubation and complications will be noted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I & II patients aged 18-60 years of either sex undergoing elective surgery under general anaesthesia requiring endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
Mouth opening < 2.5 cm
patients with oral pathology
patients with cervical spine pathology
pregnant patients
patients on antihypertensive drugs |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for the endotracheal intubation |
Time taken from introduction of the C-MAC videolaryngoscope or flexible fiberoptic bronchoscope into the mouth till placement of the Endotracheal tube under vision into trachea |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Rate of successful tracheal intubation
2)Haemodynamic variations
3)complications ( blood staining on device, cough during intubation, blood in the field of vision of airway device and incident of postoperative sore throat will be recorded) |
Haemodynamic variations ( Heart rate and Mean arterial pressure) in first ten minutes for every one minute.
24hr postoperatively
|
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2019 |
| Date of Study Completion (India) |
21/05/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Endotracheal intubation is the gold standard to secure definitive airway. Various airway devices have been investigated for managing patients with difficult airway over the years and availability of these advanced gadgets made the management of anticipated difficult airway very successfull even when the patient is awake. Flexible fiberoptic intubation is still point of care in the management of difficult airway in awake patients. The C-MAC is a recently introduced video laryngoscope which has Mcintosh type of blade and a specially positioned micro camera on the distal portion of the blade. ASA I&II patients between age 18-60 years of either sex who are posted for elective surgery requiring general anaesthesia are selected and kept NPO before surgery. Before 30 mins of the surgery inj Glycopyrrolate 0.2 mg I.M will be given to the patient followed by nebulization with 5ml of 4% lignociane sollution followed by gargles with 10 ml of 2% viscous lignocaine. Then 4 puffs of 10% lignocaine metered spray will be sprayed over the mucosa of oropharynx, faucial pillars, base of the tongue and posterior pharyngeal wall. Then patient shifted in to the operation theater and all ASA standard monitors are attached and IV Cannula will be secured on non dominant hand and Loading dose of Dexmedetimidine ( 1 mcg/kg ) will be infused over 10 minutes and patient intubated either using C-MAC or Fiberoptic Bronchoscope.Time taken for tracheal intubation will be noted. |