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 |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
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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 |
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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 |
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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
|
|
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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: T884||Failed or difficult intubation, |
|
Intervention / Comparator Agent
|
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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 |
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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. |
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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)?
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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?
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. 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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