| CTRI Number |
CTRI/2020/01/022818 [Registered on: 16/01/2020] Trial Registered Prospectively |
| Last Modified On: |
15/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out which head and neck features of the patient make putting of tube in windpipe difficult |
|
Scientific Title of Study
|
Evaluation of airway characteristics predicting difficult videolaryngoscopy- guided tracheal 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 |
Rishabh Sharma |
| Designation |
Postgraduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Operation theatre 2, Main OT Block, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
26198462 |
| Fax |
|
| Email |
rishabhsharma1973@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smita Prakash |
| Designation |
Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Main Operation Theatre, 2nd Floor, Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029 New Delhi 110029
South
DELHI
110029
India |
| Phone |
26198462 |
| Fax |
|
| Email |
drsunilprakash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Smita Prakash |
| Designation |
Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Main Operation Theatre, 2nd Floor, Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029 New Delhi 110029
DELHI
110029
India |
| Phone |
26198462 |
| Fax |
|
| Email |
drsunilprakash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smita Prakash |
Safdarjung Hospital |
Main Operation Theatre, 2nd Floor, Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029 New Delhi 110029
South
DELHI |
26198462
drsunilprakash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMMC and Safdarjung Hospital Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists physical status grade I or II adults
Age 18 to 65 years
Scheduled for elective surgery under general anaesthesia with tracheal intubation |
|
| ExclusionCriteria |
| Details |
1.Patients who require awake fibreoptic-guided tracheal intubation
2.Patients requiring rapid sequence intubation or at risk of aspiration
3.Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Airway characteristics that predict difficult CMAC video laryngoscopy guided tracheal intubation defined as intubation time 60 s |
At intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Cormack-Lehane score and percentage of glottic opening (POGO) scores
2.Modified intubation difficulty scale score
3.Number of attempts needed for successful intubation
|
At intubation |
|
|
Target Sample Size
|
Total Sample Size="185"
Sample Size from India="185"
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)
|
20/01/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Previous studies have identified several risk
factors that predict difficult laryngoscopy and difficult intubation using
conventional direct laryngoscopy. There are limited studies evaluating
risk factors for difficult VL. These previous studies have been conducted
using the Glidescope VL. There is paucity of literature with regard
to risk factors that predict difficult C-MAC VL guided TI.
Predictive indices for difficult intubation will
help in warning the clinician of difficult laryngeal exposure and tracheal
intubation when obvious risk factors are not evident so that safer intubation
strategies can be adopted. The study hypothesis is that airway characteristics
can predict difficult videolaryngoscopy-guided tracheal intubation in adult
patients undergoing elective surgery under general anaesthesia. The aim of this
study is to determine airway characteristics that predict difficult CMAC video
laryngoscopy guided tracheal intubation in adult patients undergoing elective
surgery under general anaesthesia.
|