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CTRI Number  CTRI/2025/09/094231 [Registered on: 04/09/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
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   Use of different method of head position for securing airway in patient with difficult airway 
Scientific Title of Study   Comparison of Intubation Success with the Conventional Sniffing Position versus Left Head Rotation (LeHeR) Manoeuvre Using Direct Laryngoscopy in Patients with Anticipated Difficult Intubation: A Prospective, Randomized 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  Maria Robinson I 
Designation  Junior resident 
Affiliation  IGIMS,Patna 
Address  Department of Anaesthesiology, First floor, Ward block, IGIMS, Patna

Patna
BIHAR
800014
India 
Phone  9486737107  
Fax    
Email  mariarobinson108@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swati Singh 
Designation  Associate professor 
Affiliation  IGIMS,Patna 
Address  Department of Anaesthesiology, First floor, Ward block, IGIMS,Patna

Patna
BIHAR
800014
India 
Phone  9878309230  
Fax    
Email  drswatisingh21@gmail.com  
 
Details of Contact Person
Public Query  
Name  Maria Robinson I 
Designation  Junior resident 
Affiliation  IGIMS,Patna 
Address  Department of Anaesthesiology, First floor, Ward block, IGIMS,Patna

Patna
BIHAR
800014
India 
Phone  9486737107  
Fax    
Email  mariarobinson108@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna Pincode 800014 
 
Primary Sponsor  
Name  Maria Robinson I 
Address  Department of Anaesthesiology, First floor, Ward block, IGIMS,Patna 
Type of Sponsor  Other [SELF] 
 
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 
Maria Robinson I  Indira Gandhi Institute of Medical Sciences, Patna  Department of Anaesthesiology First Floor, Ward block, Near Neuro OT
Patna
BIHAR 		 09486737107

mariarobinson108@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, IGIMS, Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CONVENTIONAL  In the sniffing position technique, patients will be placed in the supine position, and a pillow will be placed under the patients occiput to facilitate cervical flexion, and the head will be extended to attain extension of the atlanto-occipital joint. The procedure will be done prior to laryngoscopy at the time of endotracheal intubation. 
Comparator Agent  LeHeR technique (Left Head Rotation technique)  In the LeHeR technique, patients will be placed in a supine position with simple neck extension and head rotated to the left up to 45 degrees with the aid of a protractor. The procedure will be done prior to laryngoscopy at the time of endotracheal intubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.18–70 years
2. BMI range of 18.5 – 40 kg per meter square,
3. ASA grades I and II, III
4. Anticipated difficult airway as assessed by ultrasound measurement. 
 
ExclusionCriteria 
Details  1. Neck anomalies
2. Cervical spine pathology,
3. Facial trauma obstructing the airway,
4. History of gastroesophageal reflux,
5. 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   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the success rate of the first intubation attempt using direct laryngoscopy in two different techniques—the conventional sniffing position versus the left head rotation (LeHeR) technique—in patients with an anticipated difficult intubation.  Airway assessment in preoperative area, at the time of laryngoscopy and endotracheal intubation 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the time to endotracheal intubation between the two groups.
2. To compare the Cormack-Lehane (CL) grading in both techniques.
3. To compare the number of attempts to successful intubation
4. To compare the use of external laryngeal manipulation.
5. To compare the use of adjuncts (stylet, bougie) between two techniques.
6. The need for greater expertise during endotracheal intubation.
 		 At the time of laryngoscopy & endotracheal intubation 
 
Target Sample Size   Total Sample Size="264"
Sample Size from India="264" 
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 4 
Date of First Enrollment (India)   21/09/2025 
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)   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 a critical, life-saving intervention. Endotracheal intubation in a challenging airway necessitates technical expertise, access to appropriate devices, and accurate evaluation of the clinical condition. Experienced as well as novice physicians or allied health professionals frequently face challenging intubation scenarios in hospital and prehospital environments. Moreover, anticipating complications related to airway management remains a challenge for anesthesiologists.

An unanticipated difficult intubation is a potentially critical situation during airway management. Many different methods have been proposed to manage this situation. In 2019, the "LeHeR" (Left Head Rotation) method was proposed to improve direct laryngoscopy in patients with unanticipated difficult laryngoscopy and intubation. 

The DARES Protocol is a succinct, standardized ultrasound examination to predict difficult laryngoscopy based on upper airway measurements with the most robust data. The protocol involves only two views of the upper airway: the thyrohyoid and the suprahyoid views. Measurements selected for this protocol include the DSE, HMD, HMDR1, HMDR2, and tongue thickness, which cover all three domains of TTD, APD, and OSD.

We hypothesize that the use of the LeHeR manoeuver can improve the visualization of vocal cords and improve the chances of successful endotracheal intubation in patients with anticipated difficult intubation as defined by DARES protocol. Thus, we plan to compare the conventional sniffing position with the LeHeR manoeuvre in adult patients with anticipated difficult intubation.

 
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