| 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
|
|
|
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
|
|
|
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
|
|
|
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. |