| CTRI Number |
CTRI/2025/08/093905 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between two medical devices. |
|
Scientific Title of Study
|
A Prospective comparative study of use of macintosh laryngoscope blade versus videolaryngoscope for intubation in adult patients undergoing 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 Jyoti Sharma |
| Designation |
Junior Resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of Anaesthesia, Lala Lajpat Rai Memorial college, Meerut, Uttar Pradesh, India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8076969997 |
| Fax |
|
| Email |
drjyotisksharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Kumar Manik |
| Designation |
Professor |
| Affiliation |
Lala Lajpat Rai Memorial Medical College |
| Address |
Department of Anaesthesia, Lala Lajpat Rai Memorial Medical college, Meerut, Uttar Pradesh, India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9634857368 |
| Fax |
|
| Email |
dr.yogeshkmanik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Kumar Manik |
| Designation |
Professor |
| Affiliation |
Lala Lajpat Rai Memorial Medical College |
| Address |
Department of Anaesthesia, Lala Lajpat Rai Memorial Medical college, Meerut, Uttar Pradesh, India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9634857368 |
| Fax |
|
| Email |
dr.yogeshkmanik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia, Lala Lajpat Rai Memorial Medical
College, Meerut
UTTAR PRADESH
250004
|
|
|
Primary Sponsor
|
| Name |
LLRM Medical College |
| Address |
Department of anaesthesia, Lala Lajpat Rai Memorial Medical
College, Meerut
UTTAR PRADESH
250004
India
|
| 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 Jyoti Sharma |
LLRM Medical college Meerut |
Department of anaesthesia LLRM Medical College Meerut Uttar Pradesh
Meerut
UTTAR PRADESH |
8076969997
drjyotisksharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, LLRM Medical college, Meerut |
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 |
Insertion of laryngoscope |
Comparison of various parameters like hemodynamic changes, ease of insertion, number of attempts, complications, cormack Lenhane grading, time taken for intubation .
We conducted this study over a period of 18 months. |
| Comparator Agent |
Macintosh laryngoscope blade |
During elective surgery intubation is done via macintosh laryngoscope blade and parameters like total number of attempts at intubation , time taken for intubation, Cormack Lehane grading, complications, hemodynamic changes, ease of intubation will be noted at immediately post intubation at 1 minute, 5 minutes and 10 Minutes. |
| Comparator Agent |
Videolaryngoscope laryngoscope blade |
During elective surgery intubation is done via videolaryngoscope laryngoscope blade and parameters like total number of attempts at intubation , time taken for intubation, Cormack Lehane grading, complications, hemodynamic changes, ease of intubation will be noted at immediately post intubation at 1 minute, 5 minutes and 10 Minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II
Age 18 and 65 years
Patients undergoing elective surgery
Patients with informed consent |
|
| ExclusionCriteria |
| Details |
Patient with ASA Grade III and IV
Patient with decompensated heart failure or elevated intra cranial pressure
Pregnancy
Patients refusal
Patients undergoing emergency surgery
Patient with reduced mouth opening
Unstable cervical spine
Traumatic injury to face |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the percentage of successful first pass endotracheal intubation in both groups. |
Insertion of laryngoscope till the confirmation of endotracheal tube at 1 minute, 3 minutes and 5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total duration of successful endotracheal intubation
2. Percentage of successful intubation in 2nd or 3rd attempt
3. Complications (trauma, hypoxemia, esophageal intubation)
4. Compare Cormack-lehane grading of glottic visibility.
5. Hemodynamic changes post intubation |
Immediately at post intubation, at 1 minute, 5 minute and 10 minutes. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
16/09/2025 |
| 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="4"
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
|
This study is a prospective comparative study of use of Macintosh laryngoscope blade versus Videolaryngoscope blade for intubation in adult patients undergoing elective surgery. In which primary objective is to compare percentage of successful first pass endotracheal intubation in both groups.
Secondary objectives of this study includes total duration of successful endotracheal intubation, percentage of successful intubation in 2nd or 3rd attempt, complications encountered, compare Cormack-Lehane grading of glottis visibility, hemodynamic changes post intubation. |