| CTRI Number |
CTRI/2024/03/064867 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see the effect of stylet bending at respiratory tube holding position during insertion of respiratory tube using c mac video laryngoscope in adult patients posted for preplanned operations |
|
Scientific Title of Study
|
A prospective observational study to determine the efficacy of stylet angulation at the holding position during endotracheal intubation using c mac video laryngoscope 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 Merin Varghese |
| Designation |
Assistant Professor |
| Affiliation |
DR B R Ambedkar Medical College and Hospital |
| Address |
Department Of Anaesthesiology, DR B R Ambedkar Medical College and Hospital, KG Halli, Bangalore
Bangalore KARNATAKA 560045 India |
| Phone |
8547502337 |
| Fax |
|
| Email |
merinvv@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Merin Varghese |
| Designation |
Assistant Professor |
| Affiliation |
DR B R Ambedkar Medical College and Hospital |
| Address |
Department Of Anaesthesiology, DR B R Ambedkar Medical College and Hospital, KG Halli, Bangalore
Bangalore KARNATAKA 560045 India |
| Phone |
8547502337 |
| Fax |
|
| Email |
merinvv@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Merin Varghese |
| Designation |
Assistant Professor |
| Affiliation |
DR B R Ambedkar Medical College and Hospital |
| Address |
Department Of Anaesthesiology, DR B R Ambedkar Medical College and Hospital, KG Halli, Bangalore
Bangalore KARNATAKA 560045 India |
| Phone |
8547502337 |
| Fax |
|
| Email |
merinvv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar Medical College and Hospital Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Merin Varghese |
| Address |
Department of Anaesthesiology, DR B R Ambedkar Medical College and Hospital, Bangalore |
| Type of Sponsor |
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 Merin Varghese |
DR B R Ambedkar Medical College and Hospital |
Department of Anaesthesiology, OT complex, first floor, Bangalore KARNATAKA |
8547502337
merinvv@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 |
Angulated Stylet |
Stylet angulation at holding position used for tracheal intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All the patients posted for elective surgeries under general anaesthesia with oro-tracheal intubation, Patients aged between 18-65 years of age, Patients belonging to American Society of Anaesthesiologists Physical Status (ASA-PS) I and II |
|
| ExclusionCriteria |
| Details |
Patients with known predictors of difficult intubation, BMI more than 30kg/m2, Patients with previous history of difficult intubation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the time for successful placement of endotracheal tube |
At baseline during laryngoscopy and endotracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the first pass success rate for tracheal intubation, Number of optimization manoeuvres required, Number of intubation attempts, Complications if any |
At baseline from laryngoscopy till the successful placement of tracheal tube |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
15/04/2024 |
| 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="0" 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. Difficulties during routine intubation in the operating room occur in 1-6% of cases and intubation failure occurs in 0.1-0.3% of cases1. 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 better illumination of light source and camera on the tip of the blade, enabling better visualization of the airway anatomy and ultimately making it easier to visualize the entrance of larynx. C-MAC video laryngoscope, initially designed primarily as a teaching tool,may be useful device in the clinical settings also as it can be used as a standard direct laryngoscope or as an indirect laryngoscope. When used as direct laryngoscope, it functions like any Macintosh laryngoscope 6. However, the good laryngeal view provided by the videolaryngoscopes does not always guarantee successful or easy intubation and it can be tricky and time consuming in emergency scenarios. Although gaining a view of the glottis is the easy part when using a video laryngoscope, tube delivery to the glottis is often difficult with a video laryngoscope because oral, pharyngeal and laryngeal axis are not aligned and thus the tip of the tube must pass around an acute angle to enter the larynx2. An intubating stylet is widely used to assist manipulation of the tube tip to allow necessary maneuverability to advance it beyond tation and might be especially useful in less experienced providers like junior residents and paramedics. Video laryngoscopes are equipped with better illumination of light source and camera on the tip of the blade, enabling better visualization of the airway anatomy and ultimately making it easier to visualize the entrance of larynx. C-MAC video laryngoscope, initially designed primarily as a teaching tool,may be useful device in the clinical settings also as it can be used as a standard direct laryngoscope or as an indirect laryngoscope. When used as direct laryngoscope, it functions like any Macintosh laryngoscope 6. However, the good laryngeal view provided by the videolaryngoscopes does not always guarantee successful or easy intubation and it can be tricky and time consuming in emergency scenarios. Although gaining a view of the glottis is the easy part when using a video laryngoscope, tube delivery to the glottis is often difficult with a video laryngoscope because oral, pharyngeal and laryngeal axis are not aligned and thus the tip of the tube must pass around an acute angle to enter the larynx2. An intubating stylet is widely used to assist manipulation of the tube tip to allow necessary maneuverability to advance it beyond the glottic opening into the trachea. When angulating a stylet in the sagittal plane at the operators holding position, the holding force of the right thumb is divided into vectors in a longitudinal direction and acts on the tip of the tracheal tube by using the index finger or middle finger as a fulcrum during the entire process of placement of the endotracheal tube. Therefore, the tube tip can be efficiently and precisely operated by finger movement that is suitable for fine manipulation1. There is knowledge lacunae whether angulating the stylet at holding position should be done routinely when performing tracheal intubation with C-MAC video laryngoscope6. Hence, in our study we would like to observe whether stylet angulation at the holding position would improve maneuverability of the tracheal tube and contribute to easy, smooth, and swift tube placement during endotracheal intubation using a C-MAC video laryngoscope. |