| 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
|
|
|
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
|
|
|
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. |