CTRI Number |
CTRI/2022/08/044684 [Registered on: 05/08/2022] Trial Registered Prospectively |
Last Modified On: |
13/07/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of efficacy of three types of laryngoscopes in adult patients posted for surgery |
Scientific Title of Study
|
A prospective randomised study to compare the efficacy of C-Mac Videolaryngoscope, VL3R videolaryngoscope and Macintosh laryngoscope as intubating aids 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 |
Akshaya Devi R |
Designation |
Junior Resident |
Affiliation |
Jawaharlal Nehru Medical College |
Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh UTTAR PRADESH 202002 India |
Phone |
9962978297 |
Fax |
|
Email |
akshayar95@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Qazi Ehsan Ali |
Designation |
Professor |
Affiliation |
Jawaharlal Nehru Medical College |
Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh UTTAR PRADESH 202002 India |
Phone |
7417701769 |
Fax |
|
Email |
qaziehsanali@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Qazi Ehsan Ali |
Designation |
Professor |
Affiliation |
Jawaharlal Nehru Medical College |
Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh UTTAR PRADESH 202002 India |
Phone |
7417701769 |
Fax |
|
Email |
qaziehsanali@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, AMU, Aligarh |
|
Primary Sponsor
|
Name |
Department of Anaesthesiology and Critical Care Jawaharlal Nehru Medical College AMU Aligarh |
Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, AMU, Aligarh |
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 |
Akshaya Devi R |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
Department of Anaesthesiology and Critical Care, SOT Aligarh UTTAR PRADESH |
9962978297
akshayar95@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Intubation |
Intubation using C Mac videolaryngoscope |
Comparator Agent |
Intubation |
Intubation using VL3R videolaryngoscope |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
ASA Grade I &II patients.
Age between 20-70 years
Weight between 40-70 kgÂ
Patients of both sexes
Patients planned for elective surgery
MP Grades I and II
|
|
ExclusionCriteria |
Details |
Previous history of multiple/ failed intubation.
Predicted difficult laryngoscopy
Any pathology of the oral cavity that may obstruct the insertion of device
Mouth opening less than 2.5cm.
Potentially full stomach patients (trauma, morbid obesity, pregnancy, history of gastric regurgitation and heartburn) and at risk of esophageal reflux (hiatus hernia). |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To compare the number of attempts required for successful intubation.
|
2 years |
|
Secondary Outcome
|
Outcome |
TimePoints |
To grade the ease of tracheal intubation using these devices.
To compare the laryngoscopy and intubation time using the three intubating devices.
To compare the number of adjustment maneuvers required for successful intubation each device.
To look for any complications like trauma and sore throat during laryngoscopy and intubation.
|
2 years |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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
|
Phase 3 |
Date of First Enrollment (India)
|
16/08/2022 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
A PROSPECTIVE RANDOMIZED STUDY TO COMPARE THE EFFICACY OF C-MAC VIDEO LARYNGOSCOPE, VL3R VIDEO LARYNGOSCOPE AND MACINTOSH LARYNGOSCOPE AS INTUBATING AIDS IN ADULT PATIENTS Airway management is quite essential in cardiopulmonary resuscitation, anaesthesia, emergency medicine, intensive care and first aid, as it saves lives. Laryngoscopy may be performed to facilitate tracheal intubation during general anaesthesia or cardiopulmonary resuscitation or for surgical procedures on the larynx or other parts of the upper tracheobronchial tree. Direct laryngoscopy (DL) does not always allow optimal viewing of the glottis, especially in those patients with anatomical characteristics which can make tracheal intubation difficult1. The American Society of Anesthesiologists’ closed claim study showed that difficult intubation or esophageal intubation is the cause of the approximately 35% of life-threatening respiratory events, including death and permanent brain damage2. Thus managing a difficult airway is one of the major problems that an anaesthesiologist can encounter in clinical practice. These issues have stimulated the development of multiple novel laryngoscopes, each of which aims to improve the laryngeal view, especially in cases of anticipated/unanticipated difficult airway3. The greater effectiveness of video-laryngoscopes associated with multi-person visualization could enhance overall patient safety during airway management4. Although they offer several advantages, including better view of glottis entrance and intubation conditions, a good laryngeal view does not guarantee easy or successful tracheal tube insertion5.
We therefore aim to compare the number of attempts required for successful intubation using C – MAC video laryngoscope, VL3R video laryngoscope and Macintosh laryngoscopes and to arrive at a conclusion and to grade them based on the various characteristics.
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