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CTRI Number  CTRI/2014/12/005342 [Registered on: 31/12/2014] Trial Registered Retrospectively
Last Modified On: 18/12/2014
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Observational Survey 
Study Design  Other 
Public Title of Study   Anticipated difficult airway management among anaesthesiologists  
Scientific Title of Study   A Survey on approach to anticipated difficult airway management among anaesthesiologists with a focused interest in Airway management: 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raghu S Thota 
Designation  Associate Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesiology Critical Care and Pain E Borges Road Parel
Department of Anaesthesiology, Critical Care and Pain E Borges Road Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  09769077764  
Fax  09769077764  
Email  ragstho24@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Raghu S Thota 
Designation  Associate Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesiology Critical Care and Pain E Borges Road Parel
Department of Anaesthesiology, Critical Care and Pain E Borges Road Parel

MAHARASHTRA
400012
India 
Phone  09769077764  
Fax  09769077764  
Email  ragstho24@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Raghu S Thota 
Designation  Associate Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesiology Critical Care and Pain E Borges Road Parel
Department of Anaesthesiology, Critical Care and Pain E Borges Road Parel

MAHARASHTRA
400012
India 
Phone  09769077764  
Fax  09769077764  
Email  ragstho24@rediffmail.com  
 
Source of Monetary or Material Support  
Investigator Initiated trial 
 
Primary Sponsor  
Name  Raghu S Thota 
Address  404 B Wing Gandhar Tower Sayani road Prabhadevi Mumbai 25 
Type of Sponsor  Other [Investigator Initiated Trial] 
 
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 
Raghu S Thota  Department of Anaesthesiology, Critical Care & Pain, Room 19 to 33, Tata memorial Hospital  E Borges Road, Parel, Mumbai 12
Mumbai
MAHARASHTRA 
9769077764

ragstho24@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Tata Memorial Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy practicing Anaesthesiologists 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  All Practicing Anaesthesiologists with focussed interest in Airway Management 
 
ExclusionCriteria 
Details  Nil 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This is a Observational study where the approach of the anesthesiologist to anticipated difficult airway management is recorded  3 months after the first time the survey is sent to the anaesthesiologist 
 
Secondary Outcome  
Outcome  TimePoints 
twoo reminder 30 days and 15 days apart will be given during this two months  3 months. No secondary outcomes 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   28/11/2014 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Airway management is an important aspect in the practice of anaesthesia. There are many surveys conducted across the world1-6 assessing difficult airway management, training and equipment availability. While, India has not published its own data and has no algorithms for management of difficult airway, we have adopted American society of anaesthesiologists (ASA) and Difficult Airway Society (DAS) algorithms for the training and management of airways. We plan to evaluate the current practice patterns of the Indian anaesthesiologists with special interest in Airway management, in management of predicted difficult airway and the available airway equipments as advised by the ASA. We survey anaesthesiologists who are members of Indian society of Anaesthesiologist (ISA) and All India difficult airway association (AIDiAA). 

MATERIALS & METHODS:

The Delphi survey methodology will be used. A panel of 5 senior physicians who are practicing anaesthesiologists will be involved directly in formulating the questionnaire. The first step in designing the survey will be to prepare a questionnaire with clinical relevance to the aims of the survey. We will be preparing a set of four case scenarios (2 emergency and 2 elective) keeping in mind the difficult airway possibilities at Supraglottic, periglottic and subglottic region, as well as a cervical spine injury along with elective case scenario. Re-evaluation of the questions will be made for the second time and answer options will be evaluated for their relevance to the aim of the survey. Multiple choice options will be created with an easy to use “check the box” system to provide responses. As the clinical practices will be expected to be different for different group of patients, multiple options of standard difficult airway management will be provided.

The set of questions will be formatted into two sections, i.e. the first section will consist of questions on personal details (i.e. demographic information including work practice (location and full-time equivalent percentage), age, duration of practice, anaesthesia qualifications, etc.) of the participants. The second part will cover availability of difficult airway equipment and will be based on the ASA’s suggested contents of a portable storage unit for difficult airway management. The third part consists of four case scenarios describing patients requiring tracheal intubation, as will be outlined in the Appendix. In all cases the airway will be predicted to be difficult. There will be 2 emergencies and 2 elective case scenarios. Of the emergency cases, there will be one case of suspected Supraglottic pathology, one involved periglottic pathology, subglottic and a trauma patient with unknown cervical spine status. Practitioners will be asked to select a method of induction, method of intubation and preferred adjunct device for each scenario.

 

STUDY PROCEDURE:

Conduct of survey

The database of the registered members of All India Difficult Airway Association (AIDiAA) whose members are distributed across the country, will be obtained after due permission. Also, delegates and faculties attending the National Airway conference to be held during 28th Nov – 30th Nov 2014 will be surveyed. The time period allotted to complete the survey will be 2 months. 3 reminders to complete the survey will be sent through e-mail to the non-responders during the study period.

Received data will be entered into an Excelâ„¢ (Microsoft Office 2003) spreadsheet by two independent operators and cross-checked. Partially incomplete forms will be included with blank responses coded as missing data. If two options are selected, then data will coded as missing.

 

STATISTICAL ANALYSIS:

Data will be analysed using SPSS version 14.0 (SPSS Inc., Chicago, IL, USA). Frequencies and cross-tabulations will be used to describe the data. Descriptive statistics will be used to present demographic data and to present the results of workplace scenarios and available equipment.

 

REFERENCES:

1.    Ortega R, Mehio AK, Woo A, Hafez DH: Videos in clinical medicine: Positive-pressure ventilation with a face mask and a bag-valve device. N Engl J Med 2007; 357:e4

2.    Adnet F: Difficult mask ventilation: An underestimated aspect of the problem of the difficult airway? Anesthesiology 2000; 92:1217-1218.

3.    Soleimanpour H, Gholipouri C, Golzari SE, Rahmani F, Sabahi M. Capnography in the emergency department. Emerg Med. 2012; 2:e123.

4.    Sokouti M, Montazeri V. Acute nonpenetrating tracheobronchial injuries: What is important in the mortality? J Cardiovasc Thorac Res. 2009; 1:5–8.

 
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