FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/100267 [Registered on: 02/01/2026] Trial Registered Prospectively
Last Modified On: 31/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role change for external laryngeal manipulation (ELM) and Intubation 
Scientific Title of Study   Role change by Laryngoscopist and Assistant for external laryngeal manipulation (ELM) and Intubation 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Zia Arshad 
Designation  Professor 
Affiliation  King Georges Medical University 
Address  B-108, faculty Apartment, Jagat Narayan Road, King Georges Medical University, Chowk, Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415722226  
Fax    
Email  ziaarshad13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Zia Arshad 
Designation  Professor 
Affiliation  King Georges Medical University 
Address  B-108, faculty Apartment, Jagat Narayan Road, King Georges Medical University, Chowk, Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415722226  
Fax    
Email  ziaarshad13@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Zia Arshad 
Designation  Professor 
Affiliation  King Georges Medical University 
Address  B-108, faculty Apartment, Jagat Narayan Road, King Georges Medical University, Chowk, Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415722226  
Fax    
Email  ziaarshad13@gmail.com  
 
Source of Monetary or Material Support  
NIl 
 
Primary Sponsor  
Name  Zia Arshad 
Address  B-108, Faculty Apartment, Jagat Narayan Road, King Georges Medical University, Chow, Lucknow 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Zia Arshad  King Georges Medical University  Room no 3, department of anesthesia, Shahmina Road, Chowk, Lucknow
Lucknow
UTTAR PRADESH 
9415722226

ziaarshad13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, KGMU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R69||Illness, unspecified, (2) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ELM and assisted intubation  During direct laryngoscopy and endotracheal intubation, external laryngeal manipulation will be done by the assistant and endotracheal intubation will be done by the anesthetist. 
Intervention  External laryngeal manipulation and intubation by assistant  During direct laryngoscopy and endotracheal intubation, external laryngeal manipulation will be done by the anesthetist and endotracheal intubation will be done by the assistant. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All patient requiring direct laryngoscopy and endotracheal intubation. 
 
ExclusionCriteria 
Details  Patients who require fiber-optic intubation, vocal card palsy or any laryngeal growth/deformity.
Patient requiring rapid sequence intubation or emergency intubation. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage of glottic opening (POGO) scores and Cormack and Lehane scale by anesthetist  At the time of laryngoscopy 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of glottic opening (POGO) scores and Cormack and Lehane scale by assistant  At the time of intubation 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   01/02/2026 
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 Yet Recruiting 
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  
Tracheal intubation is considered the gold standard in securing the airway in a variety of patient populations and operations. It is most commonly performed by using direct laryngoscopy technique. 
External laryngeal manipulation is a simple maneuver that facilitates laryngeal visualization during laryngoscopy. It coordinates the operator’s right hand with what it is being simultaneously visualized, allowing fine tuning of the manipulation to maximize the laryngeal exposure.
ELM has been shown to improve laryngeal exposure and makes better intubating conditions. ELM used to be done by the intubating person to guide the assistant to the best way of doing it to maximize the laryngeal view.
This study will be designed to test the hypothesis that ELM done by the operator offers the best laryngeal view for intubation.
The aim of this study will be to examine the changes in laryngoscopic views after ELM done by the person doing laryngoscopy and ease of intubation done by the assistant.
Objective
Primary: to compare the laryngoscopic view between operator preformed ELM and assistant performed ELM.
Secondary objective: To assis the ease of intubation if intubation is done by assistant while operator is preforming ELM.
After getting ethical committee approval and CTRI registration, this study will be done on 200 patients of age 18 to 55 years, either sex, undergoing elective surgery under general anaesthesia with endotracheal intubation requiring ELM during laryngoscopy. Written & informed consent will be taken from all patients. Patients having difficult airway, obesity ASA grade III-IV pregnancy or require fiber-optic intubation will be excluded from the study.
Laryngoscopy will be done by experienced anaesthetists with curved Macintosh blades and a trained assistant will be available to assist. The operator will perform laryngoscopy and the assistant will do the ELM. Percentage of glottic opening scores and Cormack and Lehane scale will be recorded. Then the ELM will be done by operator and the assistant will perform intubation from right side of operator. Again the POGO score and CL grade will be noted. Percentage of glottic opening scores and Cormack and Lehane scale will be use as outcome measures for comparison between different views. A 3 point scale will be use to assis the ease of intubation.
POGO ranged from 0% to 100%. A POGO of 100% denotes full visualization of the larynx from the interarytenoid notch to the anterior commissure of the vocal cords and a POGO score of zero means none of the glottis opening is seen.
Cormack and Lehane scale consisted of four grades; Grade 1 full view of the glottis, Grade 2 partial view of the glottis or arytenoids, Grade 3 only epiglottis visible and Grade 4 neither glottis nor epiglottis visible.
 
Close