| CTRI Number |
CTRI/2024/07/070179 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| 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
|
Use of C-MAC video stylet and bougie assisted video laryngoscope in identifying which is better in intubating patients with anticipated difficult airways |
|
Scientific Title of Study
|
Intubation in patients with anticipated difficult airways using C-MAC video stylet versus bougie assisted C-MAC video laryngoscope: A prospective randomized 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 Rajadurai S |
| Designation |
junior resident |
| Affiliation |
indira gandhi institute of medical sciences |
| Address |
department of anaesthesia, neuro ot complex,1st floor, ward block,igims, sheikpura, patna
Patna
BIHAR
800014
India |
| Phone |
9751627992 |
| Fax |
|
| Email |
rajaduraisuja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajadurai S |
| Designation |
junior resident |
| Affiliation |
indira gandhi institute of medical sciences |
| Address |
department of anaesthesia, neuro ot complex,1st floor, ward block,igims, sheikpura, patna
Patna
BIHAR
800014
India |
| Phone |
9751627992 |
| Fax |
|
| Email |
rajaduraisuja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind kumar |
| Designation |
additional professor |
| Affiliation |
indira gandhi institute of medical sciences |
| Address |
department of anaesthesia, neuro ot complex,1st floor, ward block,igims, sheikpura, patna
Patna
BIHAR
800014
India |
| Phone |
9534870908 |
| Fax |
|
| Email |
arvind007kumar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Department of Anaethesiology, neuro Ot complex, 1st floor, ward block IGIMS, Sheikhpura, Patna 800014 |
|
|
Primary Sponsor
|
| Name |
Dr Rajadurai S |
| Address |
Indira gandhi institute of medical sciences,department of anaesthesia,neuro ot complex,1st floor,ward block,igims,sheikpura,PATNA 800014 |
| Type of Sponsor |
Other [] |
|
|
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 Rajadurai |
Indira gandhi institute of medical sciences, patna |
Department of Anaesthesiology, Neuro OT complex, 1st floor, Indira Gandhi Institute of Medical Sciences, Patna 800014
Patna
BIHAR |
9751627992
rajaduraisuja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Indira Gandhi Institute of Medical Sciences, Patna |
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 |
Bougie assisted C-MAC video laryngoscope |
The time will be measured for intubating patients with anticipated difficult airways using Bougie assisted C-MAC video laryngoscope from the time of insertion to the first appearance of etCo2 curve in the monitor. |
| Intervention |
C-MAC video stylet |
The time will be measured for intubating patients with anticipated difficult airways using C-MAC VIDEO STYLET from the time of insertion of laryngoscope to the first appearance of etCo2 curve in the monitor. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients posted for elective surgeries under general anaesthesia
2. patients with asa1 and asa2 status |
|
| ExclusionCriteria |
| Details |
1. A patient refused to participate
2. The patient posted for emergency surgery
3. Pregnant or lactating mothers
4. Patients with unstable cervical spine injury
5. Patients with renal failure, CLD, endocrine problems, rheumatic disease, malignancy
|
|
|
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 |
| The duration of intubation in using video stylet vs bougie assisted video laryngoscope (from the insertion of laryngoscope to the appearance of first etCo2 curve on the monitor). |
At the time of intubation(ZERO HOUR) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| success rate in each attempt |
at the time of intubation(ZERO HOUR) |
| total no. of attempts |
at the time of intubation(ZERO HOUR) |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
18/07/2024 |
| 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="6"
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
|
Difficult tracheal intubation is considered the most
important cause for morbidity and mortality during induction of anesthesia. Recently, video laryngoscopy (VL) has been widely used
in cases of difficult intubation as it has shown to produce better
visualization of the anatomical airway structures. . The advanced optical system and its light source
(high intensity light-emitting diodes) led to a clear view of the vocal cord
and enabled the operator to overpass the tip of laryngoscope blade to reach
into the vallecula under vision. video stylet possesses the advantages of both rigid and flexible
intubation endoscopes . It is composed
of rigid unchanneled metal stylet with 4 cm flexible dynamic tip at which there
is light source and mini size video camera. It is connected to the monitor
screen to display the images on it, giving a direct view of vocal cord and
upper tracheal rings and so it helps in cases of anticipated difficult
intubation . It can accommodate size 6.0 endotracheal tube or greater. |