| CTRI Number |
CTRI/2025/03/082090 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Comparative Study of Conventional Sniffing Position versus Left Head Rotation (LeHeR) Manoeuvre on Glottic Visualization Using Videolaryngoscope in Elective Surgery Patients Under General Anesthesia. |
|
Scientific Title of Study
|
Effect of sniffing position versus left head rotation (LeHeR) manoeuvre on glottic visualisation during videolaryngoscopy in patients undergoing elective surgery under general endotracheal anaesthesia- A prospective randomised cross-over 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 |
Shivani Tomar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Bathinda |
| Address |
Department Of Anaesthesiology,
All India Institute of Medical Sciences, Bathinda.
Bathinda PUNJAB 151001 India |
| Phone |
7906814086 |
| Fax |
|
| Email |
tomarshivani207@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Navneh Samagh |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Anaesthesiology,
AIIMS Bathinda, Punjab.
Bathinda PUNJAB 151001 India |
| Phone |
8427264480 |
| Fax |
|
| Email |
navnehsamagh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Ankita Dey |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bathinda |
| Address |
Department Of Anaesthesiology,
AIIMS Bathinda, Bathinda,Punjab
Bathinda PUNJAB 151001 India |
| Phone |
9698506683 |
| Fax |
|
| Email |
ankitadeyslg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care, All India Institute of Medical sciences,
Bathinda |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Shivani Tomar |
Department of Anaesthesiology and Critical Care, All India Institute of Medical sciences, Bathinda |
Department of
Anaesthesiology and
Critical Care, All India
Institute of Medical
sciences,Jodhpur
romana, Mandi dabwali
road,Bathinda, Punjab
-151001
Bathinda
PUNJAB
Bathinda PUNJAB |
07906814086
tomarshivani207@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
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 |
Arm 1-Videolaryngoscopy and intubation |
Videolaryngoscopy with
conventional sniffing position
followed by left head rotation
and Intubation with second
technique. |
| Intervention |
Arm 2- Videolaryngoscopy and intubation |
Videolaryngoscopy and
Intubation with Left head
rotation followed by
conventional sniffing position
and intubation with second
technique.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
BMI range of 18.5 to 35.
ASA grade I and II
Mallampati grade I,II and III |
|
| ExclusionCriteria |
| Details |
Parturient
Thyromental distance less than six centimetres
Mouth opening less than three finger breadths
Limited head rotation
Mid-facial anomalies
Neck anomalies, cervical spine pathology
Facial fractures obstructing the airway
Known gastroesophageal reflux
Patients with a known history of coronary artery disease
Patients who are not willing to participate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect POGO score during sequential video laryngoscopy with conventional sniffing position versus left head rotation (LeHeR) technique in the same patient. |
Intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To calculate the proportion of patients in each sequence in whom optimal external laryngeal manoeuvre (OELM) was needed in order to obtain a POGO score of at least 50% |
Intraoperatively |
|
|
Target Sample Size
|
Total Sample Size="192" Sample Size from India="192"
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)
|
07/11/2025 |
| 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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 thesis aims to compare the effects of the conventional sniffing position versus the left head rotation (LeHeR) manoeuvre on glottic visualization during videolaryngoscopy in patients undergoing elective surgery under general endotracheal anesthesia. The primary objective is to assess and compare the percentage of glottic opening (POGO) score between the two techniques in the same patient, while the secondary objective is to calculate the proportion of patients requiring optimal external laryngeal manipulation (OELM) to achieve a POGO score of at least 50% in each technique. This will be a randomized, crossover study conducted over 18 months at the Department of Anaesthesia, All India Institute of Medical Sciences (AIIMS), Bathinda, Punjab. The study will involve adult patients aged 18 to 65 years, with a BMI between 18.5 and 35 kg/m², and American Society of Anaesthesiologists (ASA) physical status class I or II, who are undergoing elective surgical procedures requiring general endotracheal intubation. Patients with a variety of exclusion criteria, including significant airway or neck abnormalities, will not be included in the study. The sample size was calculated based on a non-inferiority design, with 192 patients included to account for a 10% dropout rate. Participants will be randomly assigned to one of two groups using a computer-generated randomization sequence, with each patient undergoing both techniques in a crossover manner, ensuring a washout period between the two procedures to minimize bias. Both techniques will be performed following standard anesthetic induction, which includes the administration of midazolam, lignocaine, propofol, fentanyl, and vecuronium, with pre-oxygenation prior to videolaryngoscopy. In the sniffing position, the patient will be placed in the supine position with a pillow under the occiput to flex the neck and extend the head, while in the LeHeR technique, the patient’s head will be rotated to the left by 45°. During each laryngoscopy sequence, the POGO score will be recorded, and if the score is less than 50%, optimal external laryngeal manipulation will be applied, with improvements in the POGO score noted. After completing both sequences, endotracheal intubation will be performed, and anesthesia will be maintained with titrated doses of propofol to maintain a Bispectral Index (BIS) between 40 and 60. Data will be collected on the POGO scores and the need for OELM, and analyzed using statistical software (SPSS, version 29) to compare the outcomes of the two techniques. The results of this study will contribute to a better understanding of how different head positioning techniques affect glottic visualization during videolaryngoscopy and could have implications for improving airway management in clinical practice. |