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CTRI Number  CTRI/2017/07/009010 [Registered on: 10/07/2017] Trial Registered Prospectively
Last Modified On: 28/06/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to assess whether body thickness in front of neck measured using an ultrasound useful in predicting difficulty in doing laryngoscopy(a medical procedure done for the visualisation of larynx) 
Scientific Title of Study   Difficult laryngoscopy- Is ultrasound guided anterior neck soft tissue thickness a reliable predictor? 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1198-8992  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Derlin Thomas 
Designation  Assistant Professor 
Affiliation  Azeezia Medical College Hospital 
Address  Department of Anesthesiology, Azeezia Medical College Hospital, Meeyyannoor, Kollam,Kerala,India

Kollam
KERALA
691537
India 
Phone  09447768944  
Fax    
Email  derlin.t@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Derlin Thomas 
Designation  Assistant Professor 
Affiliation  Azeezia Medical College Hospital 
Address  Department of Anesthesiology, Azeezia Medical College Hospital, Meeyyannoor, Kollam,Kerala,India

Kollam
KERALA
691537
India 
Phone  09447768944  
Fax    
Email  derlin.t@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Derlin Thomas 
Designation  Assistant Professor 
Affiliation  Azeezia Medical College Hospital 
Address  Department of Anesthesiology, Azeezia Medical College Hospital, Meeyyannoor, Kollam,Kerala,India

Kollam
KERALA
691537
India 
Phone  09447768944  
Fax    
Email  derlin.t@gmail.com  
 
Source of Monetary or Material Support  
Azeezia Medical College, Meeyyannoor,Kollam, Kerala,India-691537 
 
Primary Sponsor  
Name  Azeezia Medical College 
Address  Meeyyannoor, Kollam,Kerala, India-691537 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Derlin Thomas  Azeezia Medical College Hospital  Department of Anesthesiology, 4th Floor,Hospital main block
Kollam
KERALA 		 09447768944

derlin.t@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Azeezia Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  not applicable 
Comparator Agent  nil  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of either sex,between age 18 years- 60years,with BMI ≥ 25 kg/m2,who are scheduled to undergo general anesthesia with endotracheal intubation and are willing and able to give informed consent will be recruited to the trial  
 
ExclusionCriteria 
Details  1.pregnancy
2.upper airway patholology
3.cervical spine disease/ fractures
4.full stomach
5.hiatus hernia
6.gastroesophageal reflux disease.
7.known history of thyroid disorder/enlargement
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary objective will be to assess the sensitivity, specificity and predictive accuracy of modified mallampati with or without ultrasound guided anterior neck soft tissue thickness in predicting difficult laryngoscopy in patients with BMI ≥25 kg/m2  At the completion of the study ie at 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary objective will be to compare the sensitivity of modified mallampati with US guided anterior neck soft tissue thickness and mallampati alone in predicting difficult laryngoscopy in patients with BMI ≥25 kg/m2   At the completion of the study ie at 6 months 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   10/07/2017 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Airway has a complex anatomy and an unanticipated difficult airway remains one of the most feared complication in every operating room.Prediction of difficult airway in anesthesia is thus crucial to avoid airway catastrophes.Routine preoperative airway examination usually includes assessment of mouth opening,dentition, modified Mallampati classification,thyromental distance and neck mobility.But its sensitivity and specificity for accurate prediction of a difficult airway is not very robust.Because of the superficial location of larynx Ultrasound offers images of higher resolution than CT or MRI.Ultrasound techique is safe,cheap,reliable,non invasive, fast and repeatable.

Hence in this study we are assessing whether modified Mallampati with Ultrasound guided anterior neck soft tissue thickness reliable in predicting difficult laryngoscopy in patients with BMI more than or equal to 25 kg/m2, when compared to Mallampati  alone.
 
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