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CTRI Number  CTRI/2019/05/018986 [Registered on: 07/05/2019] Trial Registered Prospectively
Last Modified On: 06/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   An observational cross sectional study aiming to identify ultrasound predictors of a difficult airway prior to elective surgery 
Scientific Title of Study   A study comparing airway ultrasound indices and clinical assessment for the prediction of difficult laryngoscopy in elective surgical patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  K C Pant 
Designation  Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Department of Anesthesia and Critical Care, Sanjay Gandhi Post Graduate Institute, Rae Barelli Road, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  9073104167  
Fax    
Email  kayceepant@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tapas Kumar Singh  
Designation  Assistant Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute 
Address  Department of Anesthesia and Critical Care, Sanjay Gandhi Post Graduate Institute, Rae Barelli Road, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone    
Fax    
Email  singh.tapas1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Pranav Rohit Kasinath  
Designation  Resident  
Affiliation  Sanjay Gandhi Post Graduate Institiute of Medical Sciences  
Address  Department of Anesthesia and Critical Care, Sanjay Gandhi Post Graduate Institute, Rae Barelli Road, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  9073104167  
Fax    
Email  pranavroh@gmail.com  
 
Source of Monetary or Material Support  
None  
 
Primary Sponsor  
Name  Sanjay Gandhi Post Graduate Institute  
Address  Raebareli Rd, Haibat Mau Mawaiya, Lucknow, Uttar Pradesh 226014 
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 
M Pranav Rohit Kasinath   Sanjay Gandhi Post Graduate Institute of Medical Sciences  Department of Anesthesiology, Critical Care and Pain Medicine Raebareli Rd, Haibat Mau Mawaiya, Lucknow, Uttar Pradesh 226014
Lucknow
UTTAR PRADESH 
9073104167

pranavroh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sanjay Gandhi Post Graduate Institute of Medical Sciences Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T884||Failed or difficult intubation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Requiring Intubation for an Elective Surgical Procedure  
 
ExclusionCriteria 
Details  1. Any abnormalities or illness preventing the use of clinical screening tests
2. Patient has a tracheostomy tube
3. Patient is unable or unwilling to give consent  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To ascertain the cut off values of ultrasound assessment of the airway in predicting a difficult airway   The ultrasound of the airway will be assessed and performed prior to intubation and surgery onset while the grade of intubation difficulty will be assessed during intubation by an experienced senior anesthetist  
 
Secondary Outcome  
Outcome  TimePoints 
Which ultrasound measurements correlate best with the diagnosis of a difficult airway
Comparison of ultrasound indices with conventional airway examination indices in predicting difficult airway.
 
The conventional airway indices will be assessed prior to the elective surgery in the pre aesthetic clinic and the ultrasound will be done prior to the surgery itself, within a period of 24 hours. The assessment of the Cormack Lehane grading will be done while intubating the patient by an experienced senior anaesthetist. The data will be complied and studied after enrolment of all the required trial subjects.  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/05/2019 
Date of Study Completion (India) 06/08/2020 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

It is common during elective surgeries to face an unanticipated difficult airway despite clinical criteria on preoperative airway examination which indicate otherwise. This leads to delay in securing the airway, multiple laryngoscopic attempts, airway trauma and the need to mobilise expensive equipment on an emergent basis. This process is time consuming, interferes with the smooth flow of patient care and might contribute to increased morbidity in the patient population as well as physician stress.

Clinical examination criteria are not applicable in the emergency setting and in the critical care environment as patients are confused and uncooperative. This further limits their safe use as a means of assessing and preparing for a difficult airway.

There are several studies that have attempted to assess the effectiveness of a preoperative ultrasound screening of the airway for the assessment of difficult intubation. There have been pilot studies to compare the effectiveness of clinical assessment over the use of ultrasound examination but we lack any large scale study of Indian patients in our hospital environment moreover - most studies have been restricted to specific groups of patients. This study aims to fill this void.

Following approval by the Institutional Ethics Committee, the study is planned for completion over a period of 18 months. This study plans to include adults aged 18 years and above of either sex, undergoing elective surgery requiring general anesthesia with nasotracheal intubation. A preoperative ultrasound screening would be performed to assess for anterior neck soft tissue depth at the level of the hyoid bone and the thyrohyoid membrane. This measurement would be assessed for correlation with the Clinical assessment of the airway and the CL grading upon intubation.

It is always wise to plan for a difficult airway - although the history and the physical examination of a patient prior to surgery is thorough, preoperative anticipation of a difficult airway occurs in only 50% of the patients subsequently found to have a difficult airway (Baker 2015).

Current bedside tests have limited and inconsistent capacity to discriminate between patients with difficult and easy airways.(Vannucci and Cavallone 2016) In view of this finding it becomes imperative to search for better methodologies for the assessment and evaluation of the airway.

Why is this study necessary?

  1. The one indian study I discovered utilised ONLY the Mallampati grading and the anterior neck soft tissue thickness to assess for difficult laryngoscopy. I would like to use a larger number of clinical tests to look for difficult airway - a single Mallampati test is not adequate to look at airway difficulty. In addition the study tries to identify the combined utility of clinical screening tests and the ultrasound - I aim to find out if Ultrasound can replace existing clinical tests.

  2. The large Observational study from Italy (Falcetta et al, 2018) does not address the problem of applicability to the indian population. It is largely applicable to a European population. I aim to produce a study that aims to make it feasible to apply ultrasound assessment in the Indian population.


 
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