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CTRI Number  CTRI/2017/09/009614 [Registered on: 04/09/2017] Trial Registered Retrospectively
Last Modified On: 03/09/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   a study to determine the usefulness of ultrasonography to measure neck tissue to help us predict difficulty in intubation. 
Scientific Title of Study   Prediction of difficult laryngoscopy & intubation by anterior neck tissue quantification using ultrasound 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chandni Sinha 
Designation  Assistant Professor, Department of Anaesthesia 
Affiliation  AIIMS,Patna 
Address  Faculty room, OT complex, 3rd floor, Ayush PMR, AIIMS,Patna

Patna
BIHAR
801505
India 
Phone  06122451205  
Fax    
Email  chandni.doc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chandni Sinha 
Designation  Assistant Professor, Department of Anaesthesia, Department of Anaesthesia 
Affiliation  AIIMS,Patna 
Address  Faculty room, OT Complex, 3rd floor, Ayush PMR Building, AIIMS,Patna
AIIMS,Patna
Patna
BIHAR
801505
India 
Phone  06122451205  
Fax    
Email  chandni.doc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chandni Sinha 
Designation  Assistant Professor, Department of Anaesthesia 
Affiliation  AIIMS,Patna 
Address  Faculty room, OT Complex, 3rd floor, Ayush PMR Building, AIIMS,Patna

Patna
BIHAR
801505
India 
Phone  06122451205  
Fax    
Email  chandni.doc@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, Patna 
 
Primary Sponsor  
Name  AIIMS Patna 
Address  Department of Anaesthesia, Faculty Room, OT complex, 3rd floor, Ayush PMR Building,AIIMS, Patna 
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 Chandni Sinha  AIIMS,Patna  OT Complex, 3rd floor, Ayush PMR Building, AIIMS,Patna
Patna
BIHAR 
06122451205

chandni.doc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Patna IEC,(Human Studies)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA I/II,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  laryngoscopic examination  laryngoscopy would be done at the time of intubation 
Intervention  Ultrasound examination  ultrasound assessment of the airway would be done at the time of preanesthetic assessment( preoperatively)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I or II patients undergoing elective surgeries under general anaesthesia with endotracheal intubation 
 
ExclusionCriteria 
Details  Patients with history of airway trauma
Patients with anterior neck masses/ swellings
Patients with limited mouth opening/ neck extention due to various reasons
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
any correlation between anterior neck tissue measurement at the level of vocal cords and Cormack Lahane classification on laryngoscopy  at the time of laryngoscopy 
 
Secondary Outcome  
Outcome  TimePoints 
any correlation between anterior neck tissue maesurement at the level of suprasternal notch and cormack lahane classification on laryngoscopy.  at the time of laryngoscopy 
correlation between anterior neck tissue measurement at the level of thyroid isthmus and cormack lahane classification  at the time of laryngoscopy 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/04/2016 
Date of Study Completion (India) 03/11/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

 Unanticipated difficult intubation remains a primary concern for anesthesiologists  as failure to secure the airway can cause anesthesia-related life-threatening morbidity and mortality. Difficult laryngoscopy & intubation rate is still as high as 1.5-13% instead of various screening tools.  Ultrasound is a non-invasive, repeatable, portable device which provides improved visualization of airway structure. Hence we aim to study the role of airway ultrasound in predicting difficult laryngoscopy by measuring anterior neck soft tissue thickness and comparing with clinical parameters & Cormack-Lehane grading. We will  sonographically examine the neck of the patient preoperatively and will correlate it with laryngoscopic examination.

Ultrasound measurements will be performed with the patient supine and the head and neck in neutral position by the primary investigator. The thicknesses of anterior neck soft tissue at vocal cord, thyroid isthmus, and supra-sternal notch levels were obtained transversely across the anterior surface of the neck with a 13–6 MHz linear array ultrasound probe attached to a SonoSite machine (SonoSite Inc., Bothell, WA, USA). At vocal cord level (Zone I), the minimal distance from the thyroid cartilage to skin surface & 15mm to the left & right will be measured. At thyroid isthmus level (Zone II), the distance from skin to trachea & 15mm to the left & right was measured. At supra-sternal notch level (Zone III), the minimal distance from skin to trachea & 15mm to the left & right will be obtained. In the operation theatre,  laryngoscopy will be done and Cormack lahane grading will be noted.   The results obtained will be statistically analyzed. Comparison analysis will be performed using the t-test for continuous variables and chi-square or Fisher exact tests, as appropriate, for non-continuous variables. Correlation analysis will be performed using the Pearson test & p value <0.05 will be considered as significant. 

 

                                           

 
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