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CTRI Number  CTRI/2024/03/064544 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 09/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparison of laryngeal view on conventional Direct Laryngoscopy and Left Head Rotation (LeHeR) technique in patients undergoing surgery under General Anaesthesia– a prospective, randomized cross-over study 
Scientific Title of Study   Effect Of Conventional Direct Laryngoscopy And Left Head Rotation Technique On Laryngeal View In Patients Undergoing Surgery Under The General Anaesthesia– A Prospective, Randomized Cross Over Study 
Trial Acronym  LeHeR 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dinesh kumar AR 
Designation  Post graduate resident 
Affiliation  AIIMS Bathinda 
Address  Department of Anaesthesiology and Critical Care, All India Institute of Medical sciences, Jodhpur romana, Mandi dabwali road, Bathinda

Bathinda
PUNJAB
151001
India 
Phone  8870103501  
Fax    
Email  dineshravichandran1178@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Navneh Samagh 
Designation  Associate professor 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Room no 139,Department of Anaesthesiology and Critical Care, All India Institute of Medical sciences, Jodhpur romana, Mandi dabwali road, Bathinda

Bathinda
PUNJAB
151001
India 
Phone  8427264480  
Fax    
Email  navnehsamagh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shashank Umesh Pliwal 
Designation  Assistant professor 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Room no 142,Department of Anaesthesiology and Critical Care, All India Institute of Medical sciences, Jodhpur romana, Mandi dabwali road, Bathinda

Bathinda
PUNJAB
151001
India 
Phone  8451858199  
Fax    
Email  shashankupaliwal@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care, All India Institute of Medical sciences, Bathinda 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Bathinda 
Address  Department of Anaesthesiology and Critical Care, All India Institute of Medical sciences, Bathinda,Punjab -151001 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Dinesh kumar AR  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 
8870103501

dineshravichandran1178@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Bathinda Institutional Ethics Committee  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  Arm 1 -Direct Laryngoscopy and Intubation   Direct laryngoscopy with conventional sniffing position followed by left head rotation and Intubation with second technique  
Intervention  Arm 2- Direct Larngoscopy and Intubation  Direct Laryngoscopy and Intubation with Left head rotation followed by conventional sniffing position and intubation with second technique 
Comparator Agent  Cormack Lehane grading  Cormack Lehane grading and Intubation Difficulty score 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) age more than 18 years and less than 70 years
2) Body Mass Index between 18.5 and 35 kg/m2
3) American Society of Anaesthesiologists physical status I,II and III
4) Mallampati grade I,II and III 
 
ExclusionCriteria 
Details  1) pregnant patients
2) Thyromental distance less than 6 cm
3) Mouth opening less than 3 finger breadths
4) Limited head rotation
5) Mid facial anomalies
6) Neck anomalies
7) Facial fractures obstructing the airway
8) known gastroesophageal reflux
9) patients posted for emergency surgery
10) patients with a known history of coronary artery disease
11) patients who are not willing to participate 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To compare the Cormack Lehane grading in two techniques of Direct laryngoscopy with conventional sniffing position and with left head rotation technique  At the end of Direct laryngoscopy 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the Intubation Difficulty Scale with two techniques of Direct laryngoscopy with conventional sniffing position and left head rotation technique  At the end of intubation 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
Final Enrollment numbers achieved (Total)= "144"
Final Enrollment numbers achieved (India)="144" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) 25/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

In this prospective randomised cross-over study, patients will be enrolled based on the aforementioned inclusion and exclusion criteria. All the selected subjects will be assessed preoperatively and will be explained about the study in their vernacular language. A detailed patient information sheet (PIS) will be given to the patients or their next of kin. Written informed consent will be taken from the patients prior to enrolment. Detailed history and physical examination of patients will be done preoperatively. On the day of the surgery, patients will be shifted to the operation theatre and standard ASA monitors including Non-invasive blood pressure (NIBP), electrocardiography (ECG) and pulse oximetry (SpO2) monitoring will be attached. Blood pressure will be monitored at an interval of 1 minute during induction of anaesthesia as well as the total laryngoscopy sequence. Bispectral Index (BIS) monitoring sensors will be placed on the forehead after cleaning the forehead with an alcohol-based solution. BIS will be maintained between 40 and 60. A wide-bore intravenous (IV) cannula will be inserted.

 Following preoxygenation for 3 minutes, induction of anaesthesia will be done with intravenous midazolam(0.02mg/kg), Lignocaine hydrochloride 2% (1.5 mg/kg), propofol(1-2mg/kg), Fentanyl (2mcg/kg) and vecuronium (0.1mg/kg). The sequence of laryngoscopy will be determined using computer generated randomisation sequence as AB or BA (A – Laryngoscopy with Sniffing position technique and B-Laryngoscopy with LeHeR technique)  in order to avoid bias in favour of either laryngoscopy techniques.

In the Sniffing position technique, patients will be placed in the supine position and a pillow will be placed under the patient’s occiput to facilitate cervical flexion and the head will be extended to attain extension of the atlanto-occipital joint. In the LeHeR technique, patients will be placed in supine position with simple neck extension and head rotated to the left up to 45 degrees with the aid of a Goniometer or protractor. Following pre-oxygenation and induction, direct laryngoscopy with the first technique as per the assigned sequence will be done and an assessment of CL grading will be done. After assessment of CL grading, the laryngoscope will be removed and mask ventilation will be done for 3 minutes. Laryngoscopy with the second technique as per the assigned sequence will be done and CL grading will be assessed. The final intubation will be done after the completion of the second laryngoscopy technique. Intubation Difficulty Scale (IDS) Score will be assessed for the technique used.

Titrated doses of propofol at a rate of 100 to 200 mcg/kg/min will be used for maintenance (BIS between 40-60) until the laryngoscopy sequences and intubation are completed.  A bolus of propofol (0.5 mg/kg) will be administered if SBP is increased by more than 20% from the previous reading during the laryngoscopy sequence. After intubation, the further course of anaesthesia will be decided as per the discretion of the anaesthesiology in charge of that case.                                                

 
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