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CTRI Number  CTRI/2023/05/053104 [Registered on: 24/05/2023] Trial Registered Prospectively
Last Modified On: 22/05/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   A STUDY TO COMPARE TWO MEASUREMENTS IN NECK AND CHEST TO HELP IDENTIFY THE DIFFICULTY LEVEL TO PUT BREATHING TUBE INTO TRACHEA BEFORE SURGERY 
Scientific Title of Study   A STUDY OF COMPARISON OF ACROMIOAXILLO SUPRASTERNAL NOTCH INDEX (AASI) WITH THYROMENTAL HEIGHT TEST (TMHT) TO PREDICT DIFFICULT VISUALIZATION OF LARYNX 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR NANDINI C V 
Designation  ASSISTANT PROFESSOR 
Affiliation  DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIA, DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL

Bangalore
KARNATAKA
560045
India 
Phone  9535024072  
Fax    
Email  nandaklr6@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR NANDINI C V 
Designation  ASSISTANT PROFESSOR 
Affiliation  DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIA, DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL


KARNATAKA
560045
India 
Phone  9535024072  
Fax    
Email  nandaklr6@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR NANDINI C V 
Designation  ASSISTANT PROFESSOR 
Affiliation  DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIA, DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL


KARNATAKA
560045
India 
Phone  9535024072  
Fax    
Email  nandaklr6@gmail.com  
 
Source of Monetary or Material Support  
DR BR AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, KADUGONDANAHALLI, BANGALORE, 560045 
 
Primary Sponsor  
Name  DR NANDINI C V 
Address  DEPARTMENT OF ANAESTHESIA, DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, KADUGONDANAHALLI, BANGALORE 560045 
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 
Dr Nandini C V   Dr B R Ambedkar Medical College and Hospital,  OT complex, department of anaesthesiology, Dr B R Ambedkar Medical College and Hospital, Kadugondanahalli, Bangalore 560045
Bangalore
KARNATAKA 
9535024072

nandaklr6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTION ETHICS COMMITTEE DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients belonging to American Society of Anesthesiologists’ physical status (ASA PS) I and II.
Patients posted for elective surgeries requiring endotracheal intubation under general anaesthesia.
 
 
ExclusionCriteria 
Details  Patients with body mass index >35 kg/m2,
Obstetric patients,
Patients with upper airway deformities, anatomical abnormality & limitation of TMJ and Atlanto axial joint,
Oral & maxillofacial tumors,
Past history of head, neck and thoracic surgery.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the usefulness of Acromioaxillo Suprasternal notch index (AASI) with that of Thyromental height test (TMHT) for predicting the difficult visualization of larynx during endotracheal intubation in patients undergoing general anaesthesia as assessed by Cormack – Lehane grading.  pre operative period, during endotracheal intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To compare Acromioaxillo Suprasternal notch index (AASI) and Thyromental height test (TMHT) with modified Mallampati (MMP) score, upper lip bite test (ULBT), Sternomental distance (SMD), Thyromental distance (TMD) and neck circumference (NC).  pre operative period and during endotracheal intubation 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   02/06/2023 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

After obtaining approval from the Institutional Ethics Committee and written informed consent will be taken from the eligible patients with American Society of Anesthesiologists’ physical status (ASA PS) I and II who are scheduled to undergo elective surgery requiring endotracheal intubation will be enrolled in this prospective comparative observational single-center study. Each patient will be assessed before the surgery for a detailed pre-anaesthetic evaluation and clinical assessment of the airway parameters will be done. Airway assessment included are mouth opening, assessment of receding mandible or protruding upper teeth and subjective assessment of head and neck extension.

 

The following predictive test measurements will be obtained and recorded:

 

1. Acromioaxillo Suprasternal notch index (AASI) will be measured with the patients lying in supine position and the upper limbs resting by the side of the body. Using a ruler, a vertical line drawn from the top of the acromion process to the superior border of the axilla at the pectoralis muscle (line A). Then a second line drawn perpendicular to line A from the suprasternal notch [line B]. The portion of line A that lay above the intersection by line B on line A will be termed as line C. AASI is calculated by dividing the length of line C by that of line A (AASI = C/A). AASI value of >0.49 is considered as a good predictor for difficult visualization of larynx (DVL).

 

2. Thyromental height test (TMHT): The height between the anterior border of the thyroid cartilage (on the thyroid notch just between the two thyroid laminae) and the anterior border of the mentum (on the mental protuberance of the mandible) will be measured, with the patient lying supine using a pillow with mouth closed. This height will be measured with a digital depth gauge (INSIZE® Electronic Depth Gage, INSIZE). A measurement of < 50 mm is considered to be a good predictor of difficult visualization of larynx (DVL).

 

3. Modified Mallampati Classification (MMP): Mallampati classification with patient in the sitting position, mouth maximally opened, and tongue protruded, while the observer looking from the patient’s eye level will inspect the pharyngeal structures with a pen torch, without the patient phonating. The oropharyngeal view is graded as Class I where soft palate, fauces, uvula, pillars visible; Class II where soft palate, fauces, uvula visible; Class III where soft palate, base of uvula visible; and Class IV where soft palate not visible at all. Class I and II are classified as easy visualization of larynx (EVL), whereas Class III and IV are classified as difficult visualization of larynx (DVL).

 

4. Thyromental distance (TMD): It is measured as straight distance between the thyroid notch and the lower border of mental prominence, with the head fully extended and the mouth closed, using a rigid ruler. A measurement of ≤ 6.5 cm is considered to be a good predictor of difficult laryngoscopy.

 

5. Sternomental distance (SMD): It is measured as straight distance between the superior border of the manubrium sterni and the lower border of mental prominence, with the head in full extension and the mouth closed, using a rigid ruler. An SMD ≤ 13.5 cm is considered to be a good predictor of difficult laryngoscopy.

 

6. Neck circumference (NC): Circumference of neck measured using a measuring tape, at the level of thyroid cartilage. NC of > 40 cm is considered to be a good predictor of difficult laryngoscopy.

 

 

During endotracheal intubation the best laryngoscopy view will be noted according to the Cormack – Lehane (CL) grading system.

Grade I = full glottis view;

Grade IIa = glottis partly visible, anterior commissure not visualized;

Grade IIb = Arytenoids or posterior part of the vocal cord just visible.

Grade III = only epiglottis is visible;

Grade IV = no epiglottis visualized.

CL grades I and IIa are inferred as an easy visualization of the larynx (EVL) and CL grades IIb, III and IV as difficult visualization of the larynx.

 

‘Difficult Intubation’ is defined as the placement of the endotracheal tube by using conventional laryngoscopy that required > 2 attempts, lasted > 10 min, or required alternate methods to intubate.

The ‘time taken for intubation’ is defined as the time point from initiation of the first direct laryngoscopy attempt to confirmation of successful endotracheal intubation by continuous waveform capnography.

 

The study subjects would be advised about the fasting guidelines. Premedication in the form of tab. Pantoprazole 40mg will be given the day before and on the day of surgery. On the day of surgery, after confirming the duration of preoperative fasting, in the preoperative room, all enrolled patients will undergo a duly explained bedside Acromioaxillo Suprasternal Notch Index (AASI), Thyromental height test (TMHT), modified Mallampati test (MMP), Thyromental distance (TMD, Sternomental distance (SMD) & neck circumference (NC) tests.

Thereafter, the patients will be shifted to the operation theatre and standard monitors will be connected. After adequate pre-oxygenation, general anesthesia will be induced with inj. Propofol 2 mg/kg IV, inj. Midazolam 0.05 mg/kg IV, inj. Fentanyl 2mcg/kg IV, and inj. Succinyl choline 2 mg/kg IV. After 30-60 seconds of mask ventilation, a single experienced investigator (≥ 2 years of experience) will perform the laryngoscopy using Macintosh blade of appropriate size (3 or 4) in the sniffing position.  The glottic view obtained on first attempt of direct laryngoscopy without any external laryngeal maneuvers will be graded according to the Cormack–Lehane classification.

All laryngoscopies will be performed by a single experienced anesthesiologist who will not be involved in preoperative airway examination.

 
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