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CTRI Number  CTRI/2024/07/071656 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 30/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Assessing the difficulty in breathing pathway for general anesthesia using ultrasound machine 
Scientific Title of Study   Pre-operative USG Based Measurement of Airway Parameters For Predicting Difficult Airway- Cross Sectional 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  DHARSHAN P 
Designation  PG Student First Year 
Affiliation  Navodaya Medical College Hospital & Research Centre 
Address  Department of Anesthesiology, Navodaya Medical College Hospital and Research Centre Raichur 584103

Raichur
KARNATAKA
584103
India 
Phone  9844383039  
Fax    
Email  dgowda0@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Balaraju T C 
Designation  Professor and Head Of Department 
Affiliation  Navodaya Medical College Hospital & Research Centre 
Address  Department of Anesthesiology, Navodaya Medical College Hospital and Research Centre Raichur 584103

Raichur
KARNATAKA
584103
India 
Phone  9632066846  
Fax    
Email  drbalu4u@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Balaraju T C 
Designation  Professor and Head Of Department 
Affiliation  Navodaya Medical College Hospital & Research Centre 
Address  Department of Anesthesiology, Navodaya Medical College Hospital and Research Centre Raichur 584103

Raichur
KARNATAKA
584103
India 
Phone  9632066846  
Fax    
Email  drbalu4u@yahoo.com  
 
Source of Monetary or Material Support  
Navodaya Medical College Hospital & Research Centre Raichur 584103 
 
Primary Sponsor  
Name  Dharshan P 
Address  Department of Anesthesiology, Navodaya Medical College, Hospital and Research Centre, Raichur 584103 
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 DHARSHAN P  Navodaya Medical College Hospital and Research Centre  Preoperative Evaluation Room Department of Anesthesiology
Raichur
KARNATAKA 
9844383039

dgowda0@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee (IHEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cormeck Lehane Grading  After doing direct laryngoscopy the glottic view by the intubating anesthetist is classified by the Cormeck Lehane in following grades predicting difficulty in intubation Grade 1 All glottic structures are visualized Grade 2 Posterior aspect of vocal cord and arytenoids are visualized Grade 3 Only epiglottis is visualized Grade 4 No glottic structures are visualized This is done only one time at the time of intubation 
Intervention  USG based measurement of airway parameters  Using linear frequency USG probe 1.Thickness of anterior neck soft tissue is measured in transverse view and this is called Minimal Distance from Skin to Hyoid Bone (DSHB) 2. Thickness of anterior neck soft tissue in transverse view at level of thyrohyoid membrane and is called as Distance from Skin to Epiglottis Midway between hyoid bone and thyroid cartilage (DSEM) These 2 parameters are measured preoperatively only one time 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients Undergoing Surgery Under General Anaesthesia
Patient Belonging to ASA 1 to 2
Adult More Than 18-60 Years of Either Sex
 
 
ExclusionCriteria 
Details  Patient Refusal
pregnant women
maxillofacial anomalies 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
USG Assessment of Anterior Neck Preoperatively Based on 2 Parameters
A.Thickness of anterior neck soft tissue in transverse view at level of hyoid bone - Minimal distance from hyoid bone to the skin (DSHB)
B.Thickness of anterior neck soft tissue in transverse view at level of thyrohyoid membrane –Distance from skin to epiglottis midway between hyoid bone and thyroid cartilage (DSEM)

 
At baseline only in preoperative room  
 
Secondary Outcome  
Outcome  TimePoints 
Cormeck Lehane Grading measured at the time of intubation by the intubating anesthetist
 
At baseline only that is at the time of intubation  
 
Target Sample Size   Total Sample Size="97"
Sample Size from India="97" 
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)   15/08/2024 
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="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  

The aim of my study is 

A. To Ultrasonographic assessment of anterior neck preoperatively based on 2 parameters

The 2 parameters chosen will be –

1.  Thickness of anterior neck soft tissue in transverse view at level of hyoid bone - Minimal distance from hyoid bone to the skin (DSHB)

2. Thickness of anterior neck soft tissue in transverse view at level of thyrohyoid membrane –Distance from skin to epiglottis midway between hyoid bone and thyroid cartilage (DSEM)

B. To find out if the above two USG parameters can predict difficult airway in adults by correlating with Cormack and Lehane grading.

            A Cross sectional study will be conducted in the department of anaesthesiology at Navodaya medical college hospital and research centre in Raichur district of Karnataka from March 2024 to September 2025. As  approval from institutional ethical committee was obtained written and informed consent will be taken from the patients coming for surgery under general anesthesia are satisfying the inclusion criteria.

Patient detailed history taking, physical examination and necessary investigations like complete blood count, blood urea, serum creatinine, chest x ray, ECG, HIV, HBsAg etc. 

  All patients will undergo pre anaesthetic evaluation, Assessment of airway using USG was conducted preoperatively, Procedure was explained. Written and informed consent was obtained. The patient was made to lie down in supine position with head in neutral position, chin lift, looking straight with mouth closed. Ultrasound machine with linear frequency probe 3-5 MHz frequency. The linear frequency probe was placed in submandibular area in midline. The thickness of anterior soft tissue (transverse view) was obtained at 2 levels –DSHB and DSEM

  Tab Alprazolam 0.5mg and Cap Pantoprazole 40mg are given orally at night on the day before surgery. All the patients are kept nil per oral as per standard guidelines.

Preoperatively before intubation Modified Mallampatti Grading and ultrasound parameters will be recorded 

The 2 ultrasound  parameters chosen will be –

1. Thickness of anterior neck soft tissue in transverse view at level of hyoid bone - Minimal distance from hyoid bone to the skin (DSHB)

2. Thickness of anterior neck soft tissue in transverse view at level of thyrohyoid membrane –Distance from skin to epiglottis midway between hyoid bone and thyroid cartilage (DSEM) 

·         DSEM >2.03cm -predicted to be difficult airway

·         DSEM <2.03cm - predicted to be easy airway

·         DSHB >0.66cm -predicted to be difficult airway

·         DSHB <0.66cm -predicted to be easy airway

During intubation Cormeck Lehane grading will be noted

On arrival in the operating room IV line was secured and base line parameters was monitored, patient was pre-medicated with Injection Glycopyrrolate 0.004mg/kg and Injection Fentanyl 2mcg/kg, pre-oxygenated for 3 minutes with 100% oxygen. Induction was done with Injection Propofol 2mg/kg and neuromuscular blockade was achieved with Injection Succinyl choline 2mg/kg IV. Direct laryngoscopy was done by anaesthesiologist using an appropriate size curved Macintosh blade and Cormack Lehane grade noted. The intubating anaesthesiologist of not less than 3 years of experience, was not involved in the preoperative sonographic and clinical airway assessment .CL grade I and II was considered to be easy laryngoscopy. After laryngoscopy, patient was intubated with appropriate sized endotracheal tube and allowed to start with surgery and patient was monitored throughout the surgery.



 
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