| CTRI Number |
CTRI/2026/02/105021 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare Ultrasound Neck Measurements and Ease of Breathing Tube Placement in Different Head Positions |
|
Scientific Title of Study
|
A comparison of direct laryngoscopic views and changes in usg guided hyomental distance measurements in different head and neck positions,a randomised control study.
|
| 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 Inshiyeh Tasleem.M.Hiremani |
| Designation |
Postgraduate Resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, K R Road, Bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
88614464251 |
| Fax |
|
| Email |
inshiyatasleem10@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Harshaprakash B G |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, K R Road, Bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
9972076646 |
| Fax |
|
| Email |
harshaprakashbg@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Harshaprakash B G |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, K R Road, Bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
9972076646 |
| Fax |
|
| Email |
harshaprakashbg@gmail.com |
|
|
Source of Monetary or Material Support
|
| bangalore medical college and research institute |
|
|
Primary Sponsor
|
| Name |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, K R Road, Bangalore, Karnataka
560002
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 Harshaprakash B G |
Bangalore Medical College and Research Institute |
Department of Anaesthesiology Bangalore KARNATAKA |
9972076646
harshaprakashbg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cormack lehanne grading |
Laryngeal views compared using cormack grading, and ease for intubation is assessed among two groups |
| Intervention |
Ultrasound guided Hyomental distance measurements |
Before intubation, using pillow height of specific group 6cm or 9cm , hyomental distance measured in neutral and extended neck , ratio of both is then calculated |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 AND 2 PATIENTS UNDERGOING ELECTIVE SURGERIES |
|
| ExclusionCriteria |
| Details |
pregnant females, patients with BMI more than 30, patient refusal for consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the laryngeal views and changes in USG guided HMDR in different
head and neck positions using USG guided hyomental distance ratio. |
laryngoscopic views assessed at baseline during intubation 0 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the hemodynamic response to endotracheal intubation. |
to measure the variation hemodynamic parameters before, during and after intubation for every 5 minutes |
|
|
Target Sample Size
|
Total Sample Size="76" Sample Size from India="76"
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)
|
10/03/2026 |
| 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="0" Months="2" 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
|
Successful direct laryngoscopy and endotracheal intubation depend on proper head and neck positioning, airway anatomy, and cervical spine mobility. Optimal positioning improves glottic visualization and intubation ease, but the ideal head elevation required remains unclear. Traditional bedside airway assessment methods are subjective and may not reliably predict difficulty.This randomized controlled study was conducted to evaluate the effect of different pillow heights used for head and neck positioning on airway geometry and intubation characteristics. The study also assessed ultrasound guided hyomental distance and hyomental distance ratio as objective predictors of airway extensibility and ease of laryngoscopy.Adult patients undergoing elective surgery under general anesthesia were randomly allocated into two groups. Ultrasound measurements were obtained in neutral and extended positions before induction. Direct laryngoscopy was performed and laryngoscopic view and intubation difficulty were recorded. Intubation time, number of attempts, and hemodynamic responses were also noted. Results showed that the group with 9 cm pillow height demonstrated greater hyomental distance, better airway extension, improved vocal cord visualization, and shorter intubation time compared to the other group. Hemodynamic responses were comparable between groups. The study suggests that optimal head and neck positioning improves airway geometry and facilitates easier intubation. Ultrasound guided hyomental distance ratio may serve as an objective tool in preoperative airway assessment. |