| CTRI Number |
CTRI/2024/11/077380 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| 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 of intervention with two medical devices in participants |
|
Scientific Title of Study
|
A prospective randomized comparative study between clinical efficacy of miller laryngoscope lade and macintosh laryngoscope blade in adult patients with predicted normal airway 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 Charu Yadav |
| Designation |
Junior resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut Uttar Pradesh India 250004 |
| Address |
Department of anaesthesia, Lala Lajpat Rai Memorial Medical College Meerut Uttar Pradesh India 250004
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8448478824 |
| Fax |
|
| Email |
drcharuyadav1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIpin Kumar Dhama |
| Designation |
Professor and Head of Department |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut Uttar Pradesh India 250004 |
| Address |
Department of anaesthesia, Lala Lajpat Rai Memorial Medical College Meerut Uttar Pradesh India 250004
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9760014177 |
| Fax |
|
| Email |
drvipindhama@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VIpin Kumar Dhama |
| Designation |
Professor and Head of Department |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut Uttar Pradesh India 250004 |
| Address |
Department of anaesthesia, Lala Lajpat Rai Memorial Medical College Meerut Uttar Pradesh India 250004
UTTAR PRADESH
250004
India |
| Phone |
9760014177 |
| Fax |
|
| Email |
drvipindhama@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia LLRM medical college Meerut 250004 |
|
|
Primary Sponsor
|
| Name |
LLRM medical college |
| Address |
Department of anaesthesia LLRM medical college Meerut Uttar Pradesh 250004 |
| 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 |
| Charu Yadav |
LLRM medical College, Meerut |
Department of Anaesthesia, LLRM medical College, Meerut, Uttar Pradesh 250004
Meerut
UTTAR PRADESH |
8448478824
drcharuyadav1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the principal, 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 blade |
To compare clinical efficacy of Macintosh and Miller laryngoscope blades |
| Comparator Agent |
Macintosh laryngoscope blade |
Macintosh blade is a wide, curved blade. It is placed into valeculla. Immediately, post intubation haemodynamic parameters were recorded after one minute, after three minutes, after five minutes and after 10 minutes. |
| Comparator Agent |
Miller laryngoscope blade |
Miller blade is a thin straight blade. It is placed on top of epiglottis. Immediately, post intubation, haemodynamic parameters were recorded after one minute, after three minutes, after five minutes and after 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2 patients
Age 18 to 65 years of either gender
Predicted normal airway on PAC
Patients scheduled to undergo elective surgical procedure |
|
| ExclusionCriteria |
| Details |
Patients undergoing any airway surgeries
Edentulous patients
Patients with narrow mouth opening
Patients having any severe systemic disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of direct laryngoscopy, glottic view, and rate of successful endotracheal intervention |
At baseline , at 1 minute , at 2 minute at 3 minute and at 5 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic parameters and complications, if any |
After one minute, three minutes, five minutes, 10 minutes post intubation |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/11/2024 |
| 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="1"
Months="1"
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
|
A comparative study between clinical efficacy of Miller laryngoscope blade versus Macintosh laryngoscope blade in adult patients with predicted normal airway, undergoing elective surgery. We compared Macintosh and Miller blades regarding ease of direct laryngoscopy, glottic, view and rate of successful endotracheal intubation. We also compared Macintosh and Miller blades regarding haemodynamic response to intubation and any complications associated with laryngoscopy. |