| CTRI Number |
CTRI/2020/06/026234 [Registered on: 30/06/2020] Trial Registered Prospectively |
| Last Modified On: |
24/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two techniques for intubation in difficult airway patients |
|
Scientific Title of Study
|
Comparative evaluation of ease of intubation with intubating laryngeal mask airway and videolaryngoscope in patients with anticipated difficult airway |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asmita V C |
| Designation |
Post graduate |
| Affiliation |
ABVIMS and DR RML HOSPITAL |
| Address |
Department of anaesthesiology
ABVIMS and Dr RML hospital
new delhi
department of anaesthesiology
New Delhi
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
vcasmita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinod Bala Dhir |
| Designation |
Consultant |
| Affiliation |
ABVIMS and DR RML HOSPITAL |
| Address |
Department of anaesthesiology
ABVIMS and DR RML hospital
new delhi
department of anaesthesiology
New Delhi
DELHI
110001
India |
| Phone |
09868223931 |
| Fax |
|
| Email |
drvinoddhir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asmita V C |
| Designation |
Post graduate |
| Affiliation |
ABVIMS and DR RML HOSPITAL |
| Address |
Department od anaesthesiology,
ABVIMS abd Dr RML hospital
new delhi
department of anaesthesiology
New Delhi
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
vcasmita@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr RML Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
ABVIMS DR RML HOSPITAL |
| Address |
Department of Anaesthesiology |
| 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 |
| Asmita V C |
ABVIMS and DR RML HOSPITAL |
room 303,
Department of Anasethesiology,
New Delhi
DELHI |
7598314117
vcasmita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indraprastha University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M219||Unspecified acquired deformity oflimb and hand, (2) ICD-10 Condition: M219||Unspecified acquired deformity oflimb and hand, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
endotracheal intubation |
3 attempts
Under general anaesthesia |
| Comparator Agent |
Number of attempts
duration of each attempt
Success rate of intubation
|
3 attempts
Unfer general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2
modified mallampati class 3
interincisor distance more than or equal to 30 mm |
|
| ExclusionCriteria |
| Details |
risk of aspiration
allergy to drugs
history of reactive airway disease
cervical spine deformities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ease of insertion and insertion success |
10-30 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
heart rate
blood pressure |
baseline
prior to induction
prior to intubation
1 3 5 7 mins after intubation |
|
|
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 1 |
|
Date of First Enrollment (India)
|
05/07/2020 |
| 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)?
|
|
Brief Summary
|
comparative evaluation of ease of intubation with intubating laryngeal mask airway and video laryngoscope in anticipated difficult airway patients |