| CTRI Number |
CTRI/2023/10/058405 [Registered on: 06/10/2023] Trial Registered Prospectively |
| Last Modified On: |
05/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the techniques of placing the respiratory tube in adults by c mac intubation blade one with Directly seeing the vocal cords and another being placing the respiratory tube by seeing the vocal cords in the video monitor in pre planned operations |
|
Scientific Title of Study
|
A prospective observational study to compare direct laryngoscopy and video laryngoscopy using c Mac during endotracheal intubation in adults for elective surgery |
| 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 sarika |
| Designation |
Post graduate |
| Affiliation |
Dr b r ambedkar medical college and hospital kadugondanahalli bengaluru 560045 |
| Address |
Ot complex block first floor department of anaesthesia dr b r ambedkar medical college and hospital kadugondanahalli bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
8073418932 |
| Fax |
|
| Email |
drsarikahegde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh kumar |
| Designation |
Professor |
| Affiliation |
Dr b r ambedkar medical college and hospital kadugondanahalli bengaluru 560045 |
| Address |
Senior staff room first floor ot complex block department of anaesthesia dr b r ambedkar medical college and hospital kadugondanahalli bengaluru 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9845785715 |
| Fax |
|
| Email |
drsantoshkumarcc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sarika |
| Designation |
Post graduate |
| Affiliation |
Dr b r ambedkar medical college and hospital kadugondanahalli bengaluru 560045 |
| Address |
Ot complex block first floor department of anaesthesia dr b r ambedkar medical college and hospital kadugondanahalli bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
8073418932 |
| Fax |
|
| Email |
drsarikahegde@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr b r ambedkar medical college and hospital kadugondanahalli bengaluru 560045 |
|
|
Primary Sponsor
|
| Name |
Dr sarika |
| Address |
Ot complex block first floor department of anaesthesia dr b r ambedkar medical college and hospital kadugondanahalli bengaluru |
| Type of Sponsor |
Other [Other (self)] |
|
|
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 sarika |
Dr b r ambedkar medical college and hospital |
Department of anaesthesia dr b r ambedkar medical college and hospital kadugondanahalli bengaluru 560045
Bangalore
KARNATAKA |
8073418932
drsarikahegde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics committee dr b r ambedkar medical college and hospital |
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 |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients posted for elective surgeries under general anaesthesia with endo tracheal intubation patients aged between 18 and 65 years of age pateints belonging to american society of anaesthesiologists physical status I and II |
|
| ExclusionCriteria |
| Details |
Patients with known predictors of difficult intubation BMI>30kg/M2 previous history of difficult intubation limited mouth opening patients with head and neck pathology and or immobility |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess ease of glottic visualisation using modified cormack lehane score during endotracheal intubation using c Mac for direct vision of glottis aperture & as video laryngoscope |
During laryngoscopy & endotracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison between intubation characteristics like first attempt success rate number of attempts ease of insertion & total duration of insertion time mucosal trauma lip or dental injury hemodynamic response to intubation |
During laryngoscopy & endotracheal intubation |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
17/10/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Airway management plays an essential role in anaesthesia practice during both elective and emergency surgeries. Endotracheal intubation considered to be the gold standard in securing the airway and definitive technique for resuscitation.it is commonly performed using direct laryngoscope. Direct laryngoscopy is a method of using a laryngoscopy for direct visualisation of laryngeal structures under direct vision to facilitate the endotracheal intubation .Due to poor illumination, difficulties in performing conventional direct laryngoscopy arise from the limited view angle of approximately 10-15degree. Insufficient laryngoscopic view results in difficult intubation, elevated risks for trauma, failed intubations leading to anaesthesia related morbidity and mortality. Over the last few years, video laryngoscopy based on the principles of indirect laryngoscopy have been introduced into clinical practice to ease endotracheal intubation and might be especially useful in less experienced providers like junior residents and paramedics. Video laryngoscopes are equipped with a better illumination of light source and camera on the tip of the blade, enabling better visualisation of airway anatomy and ultimately making it easier to visualise the entrance of larynx. Hence Video laryngoscopy had advantage over conventional laryngoscopy for ease of endotracheal intubation procedure, better visualisation of airway structures, increase successful intubations and less trauma during intubation. |