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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthy practicing Anaesthesiologists |
|
Intervention / Comparator Agent
|
|
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 |
|
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. |