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CTRI Number  CTRI/2024/05/067195 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 09/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of two technique for predicting difficult visualization of larynx for intubation 
Scientific Title of Study   Comparison of acromio axillo suprasternal notch index (AASNI) vs ultrasound guided epiglottis to vocal cord (EVC) distance predicting difficult visualization of larynx  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KALATHIYA RIDHAM JIVRAJBHAI 
Designation  Resident doctor (MD anaesthesiology) 
Affiliation  GMERS medical college, Gotri, Vadodara 
Address  6th floor, department of anesthesiology, GMERS medical college and hospital, Gotri, Vadodara

Vadodara
GUJARAT
392001
India 
Phone  9427334488  
Fax    
Email  ridham.kalathiya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR ANUP CHANDNANI 
Designation  Professor and Head of the department of anaesthesiology, GMERS Gotri, Vadodara 
Affiliation  GMERS Medical college and Hospital, Gotri , Vadodara 
Address  6th floor, department of anesthesiology, GMERS medical college and hospital, Gotri, Vadodara

Vadodara
GUJARAT
392001
India 
Phone  9925436505  
Fax    
Email  anupchandnani29@gmail.com  
 
Details of Contact Person
Public Query
 
Name  KALATHIYA RIDHAM JIVRAJBHAI 
Designation  Resident doctor (MD anaesthesiology) 
Affiliation  GMERS Medical college and Hospital, Gotri , Vadodara 
Address  6th floor, department of anesthesiology, GMERS medical college and hospital, Gotri, Vadodara

Vadodara
GUJARAT
392001
India 
Phone  9427334488  
Fax    
Email  ridham.kalathiya@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  GMERS Hospital 
Address  Old TB campus, gotri main road, Gotri, Vadodara, Gujarat 390021 
Type of Sponsor  Government medical college 
 
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 Ridham Kalathiya  GMERS hospital  6th floor, Department of anaesthesiology, Old TB campus, Gotri main road, Gotri, Vadodara
Vadodara
GUJARAT 
9427334488

ridham.kalathiya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IHEC GMERS medical college and hospital, Gotri  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  ACROMIO AXILLO SUPRASTERNAL NOTCH INDEX (AASNI)  With the patients lying in a supine position and their upper extremities resting at the sides of the body, AASNI was calculated based on the following measurements: (1) Using a ruler, a vertical line will be drawn from the top of the acromion process to the superior border of the axilla at the pectoralis major muscle (line A) (2) A second line will be drawn perpendicular to line A from the suprasternal notch (line B) (3) The portion of line A that lay above the point at which line B intersected line A will be line C. AASNI was calculated by dividing the length of line C by that of line A (AASNI C/A).  
Comparator Agent  Ultrasound guided Epiglottis to Vocal cord (EVC) distance  In the operative room, the ultrasound view of the airway of all study patients was assessed. The patients were asked to lie down supine with active head in sniffing position. The probe was placed in the submandibular area in the midline. Without changing the position of the probe, the linear array of the ultrasound probe was rotated in the transverse planes from cephalad (coronal) to caudal (oblique transverse) The distance from the epiglottis to the midpoint of the distance between the vocal cords(EVC)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  All patients undergoing elective surgery under general anaesthesia with endotracheal intubation with direct laryngoscopy 
 
ExclusionCriteria 
Details  1) Unwilling patient
2)Patients with prior facial, cervical and pharyngeal and epiglottis surgery or trauma history
3)Patients history of difficult intubation
4)Edentulous patients
5)Patient with a mouth opening of less than 3cms
6)Patients with head and neck pathologies
7)Patients with tracheostomy tube in situ
8)Pregnancy
9)BMI more than 30 kg/m2
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
comparison of acromio axillo suprasternal notch index(AASNI) vs Ultrasound guided epiglottis to vocal cord(EVC) distance for predicting difficult visualization of larynx by cormack lehane grading  Acrmio axillo suprasternal notch index(AAASNI) and Ultrasound guided epiglottis to vocal cord(EVC) distance will be measured 30 min prior to surgery and cormack lehane grading will be seen during intubation intraoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
predicting the cormack lehane grading by above methods & prepare for difficult intubation  measurement of AASNI & EVC distance in preoperative room 30 min before surgery & prepare for difficult intubation according to results 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   20/05/2024 
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="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  

AIM OF STUDY

 To compare the Acromio Axillo Suprasternal Notch Index (AASNI) with USG guided airway assessment for predicting Cormack Lehane’s Grading for difficult intubation.

OBJECTIVES

PRIMARY OBJECTIVE

·       To compare two variable method to predict the Cormack lehane’s grading for difficult intubation with direct laryngoscopy.

 SECONDARY OBJECTIVE 

   Comparison of predictive abilities of the above methods with each other to establish the best test for airway assessment amongst them.

STUDY PROTOCOL

·   ETHICAL CONSIDERATION this study will be conducted after obtaining ethical approval by local ethical committee of GMERS MEDICAL COLLEGE AND HOSPITAL, Vadodara and topic being registered with CTRI (clinical trial registry of India)

STUDY DESIGN Prospective Randomized control, single blind clinical study with allocation concealment and a uniform allocation

·  STUDY PLACE General surgery operating unit in a tertiary care teaching hospital ( GMERS Medical college and Hospital, Vadodara)

· STUDY PERIOD over the period 6 months after the approval from ethical committee.

·  STUDY POPULATION Patient hospitalised for Elective surgery under general anaesthesia GMERS hospital college.

·   SAMPLE SIZE   we will take 100 cases based on previous studies.

INCLUSION CRITERIA

·      Patients in ASA class l-ll

·      patients aged between 18 to 50 years

·      Either sex

· All patients undergoing elective surgery under general anaesthesia with endotracheal intubation with direct laryngoscopy.

EXCLUSION CRITERIA

·       Unwilling patient

·       Patients with prior facial, cervical and pharyngeal and epiglottis surgery or trauma history

·       Patients history of difficult intubation

·       Edentulous patients

·       Patient with a mouth opening of less than 3 cms

·       Patients with head and neck pathologies

·       Patients with tracheostomy tube in situ

·       Pregnancy

·       BMI more than 30 kg/m2

METHODOLOGY

As per the departmental protocol the patients posted for elective surgery  were investigated for hematological tests ( hemoglobin , total count, differential count, platelet count), biochemical tests (renal and liver function tests ),Random blood sugar, Chest X-ray and 12 lead Electrocardiograph.

ACROMIO AXILLO SUPRASTERNAL NOTCH INDEX (AASNI)

With the patients lying in a supine position and their upper extremities resting at the sides of the body, AASNI was calculated based on the following measurements:

 (1) Using a ruler, a vertical line will be drawn from the top of the acromion process to the superior border of the axilla at the pectoralis major muscle (line A).

(2) A second line will be drawn perpendicular to line A from the suprasternal notch (line B)

(3) The portion of line A that lay above the point at which line B intersected line A will be line C. AASNI was calculated by dividing the length of line C by that of line A (AASNI C/A).

ULTRASOUND

In the operative room, the ultrasound view of the airway of all study patients was assessed. The patients were asked to lie down supine with active head in sniffing position. The probe was placed in the submandibular area in the midline. Without changing the position of the probe, the linear array of the ultrasound probe was rotated in the transverse planes from cephalad (coronal) to caudal (oblique transverse)

The distance from the epiglottis to the midpoint of the distance between the vocal cords (EVC)

The patients were subsequently induced using propofol 2mg/kg, fentanyl 2mcg/kg and vecuronium 0.1mg/kg. Endotracheal intubation was carried out by an anaesthesiologist with atleast two years of experience performing the procedure. During direct laryngoscopy, the Cormack and Lehane grading was recorded as per the following

1. Grade I visualization of the entire laryngeal aperture

 2. Grade II visualization of parts of the laryngeal aperture or the arytenoids

 3. Grade III visualization of only the epiglottis

4. Grade IV visualization of only the soft palate.

STATISTICAL ANALYSIS

·       The study will be Randomised controlled single blinded clinical study.

·     Sensitivity, specificity, Chi square test will be done for comparison of both variable methods.


 
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