| CTRI Number |
CTRI/2025/05/087672 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
24/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomized controlled trial to compare the blood pressure in response to placement of a tube in the trachea using a video laryngoscope or a video stylet in adults receiving general anesthesia |
|
Scientific Title of Study
|
A randomized controlled trial to compare the hemodynamic response to orotracheal intubation with c-mac video laryngoscope versus c-mac video stylet in adults receiving general anesthesia 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 |
Garima Agrawal |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Anesthesia, Room no 509, New Academic block, Lady Hardinge Medical college
Central DELHI 110001 India |
| Phone |
8826640501 |
| Fax |
- |
| Email |
garima2396@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Garima Agrawal |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Anesthesia, Room no 509, New Academic block, Lady Hardinge Medical college
Shahid bhagad singh marg,
Central DELHI 110001 India |
| Phone |
8826640501 |
| Fax |
- |
| Email |
garima2396@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Garima Agrawal |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Anesthesia, Room no 509, New Academic block, Lady Hardinge Medical college
Shahid bhagad singh marg
Central DELHI 110001 India |
| Phone |
8826640501 |
| Fax |
- |
| Email |
garima2396@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Department of Anaesthesia, Lady Hardinge Medical College, shahid Bhagat Singh Marg, central Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College New Delhi 110001 |
| 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 |
| Dr Garima Agrawal |
Lady Hardinge Medical College and associated hospitals |
Department of Anaesthesia, Lady Hardinge Medical College Central DELHI |
08826640501
garima2396@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lady Hardinge Medical College and associated hospitals New Delhi |
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 |
C-mac video laryngoscope |
either of the two devices are used for laryngoscopy and intubation to secure the airway and hemodynamic response to orotracheal intubation will be compared in ASA grade 1 adult patients receiving general anaesthesia for elective surgery. |
| Intervention |
C-mac video laryngoscope vs C-mac video stylet used for orotracheal intubation in adult patients receiving general anaesthesia for elective surgery |
To compare the hemodynamic response (SBP, HR, DBP, MAP) to orotracheal intubation using the two devices in ASA grade 1 adult
patients receiving general anaesthesia for elective surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status 1
2. Elective surgery |
|
| ExclusionCriteria |
| Details |
1. Anticipated difficult airway
2. Upper respiratory tract infection
3. Patients with high risk for aspiration such as hiatal hernia, gut surgeries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic response (Systolic blood pressure ) orotracheal intubation using C-MAC video laryngoscope and C-MAC video stylet in ASA grade I adult patients receiving general anaesthesia for elective surgery |
At preinduction and 1 minute after tracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare orotracheal intubation using C-MAC video laryngoscope or video stylet in ASA grade I adult patients receiving general anaesthesia for elective surgery with regards to the changes in SBP, HR, DBP, MAP |
At following time intervals
1. Preinduction
2. Preintubation
3. Immediately after tracheal intubation
4. At 1 minute after tracheal intubation
5. At 3 minutes after tracheal intubation
6. At 5 minutes after tracheal intubation |
To compare orotracheal intubation using C-MAC video laryngoscope or video stylet in ASA grade I adult patients receiving general anaesthesia for elective surgery with regards to time taken for tracheal intubation defined as the time from introduction of laryngoscope to the time of first capnography trace.
|
time taken for tracheal intubation defined as the time from introduction of laryngoscope to the time of first capnography trace.
|
| To compare orotracheal intubation using C-MAC video laryngoscope or video stylet in ASA grade I adult patients receiving general anaesthesia for elective surgery with regards to number of failed intubation |
Failure of intubation shall be defined if more than two attempts are taken to secure the
airway. In such a situation, the airway will be secured as per the anesthesiologist discretion
and the patient will be excluded from the study. |
| To compare orotracheal intubation using C-MAC video laryngoscope or video stylet in ASA grade I adult patients receiving general anaesthesia for elective surgery with regards to number of patients requiring Optimal External Laryngeal Manipulation for achieving successful intubation in each group |
OELM shall be allowed for achieving successful intubation & number of patients
requiring application of this maneuver will be recorded. |
| To compare orotracheal intubation using C-MAC video laryngoscope or video stylet in ASA grade I adult patients receiving general anaesthesia for elective surgery with regards to number of patients with Orodental trauma |
Tracheal 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
|
N/A |
|
Date of First Enrollment (India)
|
02/07/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laryngoscopy and intubation stimulate the sympathetic nervous system causing an increase in heart rate, blood pressure, pulmonary capillary wedge pressure and intracranial pressure. This hemodynamic response is transient, and is well tolerated by healthy individuals but can have deleterious consequences in high-risk patients such as those with hypertension, coronary artery diseases, intracranial space occupying lesion etc. Video laryngoscopy is now becoming a preferred method of tracheal intubation with its improved visualization and widespread availability. However, previous literature has shown that hemodynamic response to video laryngoscopy is similar to that of direct laryngoscopy as both the devices involve introduction of blades into the laryngopharynx exerting pressure to the base of the tongue, lodgment in the vallecula and elevation of the epiglottis. C-MAC Video stylet with a deflectable tip has been recently introduced to facilitate orotracheal intubation in adults. It is an optical stylet that allows indirect view of laryngopharyngeal structures without exerting pressure on the adjoining tissues. However, introduction of the stylet into the oral cavity requires application of jaw thrust or manual lifting of the mandible by hooking the lower jaw to create a pharyngeal space in order to facilitate visualization of glottis. These maneuvers are also known to elicit a sympathetic response, however, there is no research comparing the hemodynamic response of video laryngoscopy versus video stylet intubation which involves manual displacement of the jaw. There is paucity of literature comparing the hemodynamic response to orotracheal intubation by C-MAC video laryngoscope versus C-MAC video stylet in adult patients receiving general anaesthesia for elective surgery. Our study will help us identify if there is any difference in the hemodynamic response to orotracheal intubation using C-MAC video laryngoscope compared to C-MAC video stylet in adult patients receiving general anaesthesia for elective surgery and thus select appropriate laryngoscope for intubation in high risk patients. |