CTRI Number |
CTRI/2020/11/029379 [Registered on: 26/11/2020] Trial Registered Prospectively |
Last Modified On: |
05/03/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
prospective observational |
Study Design |
Other |
Public Title of Study
|
A study to evaluate if a bedside ultrasound can help in predicting difficult airway |
Scientific Title of Study
|
Can Point of care ultrasound predict the difficulty in intubation: A prospective observational study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Roopali Phulli |
Designation |
Academic Junior Resident in Department of Anaesthesia |
Affiliation |
All India Institute of Medical Sciences, Raipur |
Address |
4th Floor
A-block OT Complex Department of Anaesthesia
AIIMS Raipur
Raipur CHHATTISGARH 492099 India |
Phone |
8850819472 |
Fax |
|
Email |
roopali2693@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Samarjit Dey |
Designation |
Associate Professor |
Affiliation |
All India Institute of Medical Sciences, Raipur |
Address |
4th Floor A-Block,OT-Complex Department of Anaesthesia,Critical Care and Pain Medicine AIIMS Raipur
Raipur CHHATTISGARH 492099 India |
Phone |
8014910806 |
Fax |
|
Email |
drsamar0002@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Roopali Phulli |
Designation |
Academic Junior Resident in Department of Anaesthesia |
Affiliation |
All India Institute of Medical Sciences, Raipur |
Address |
4th Floor OT Complex
A-Block Department of Anesthesia, AIIMS Raipur
Raipur CHHATTISGARH 492099 India |
Phone |
8850819472 |
Fax |
|
Email |
roopali2693@gmail.com |
|
Source of Monetary or Material Support
|
All India Institute of Medical Sciences, Raipur |
|
Primary Sponsor
|
Name |
AIIMS Raipur |
Address |
Department of Anaesthesia,
critical care and pain medicine |
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 |
Dr Roopali Phulli |
All India Institute of Medical Sciences, Raipur |
OT Complex, A-Block, 4th Floor Raipur CHHATTISGARH |
8850819472
roopali2693@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics Committe, AIIMS Raipur |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: R68||Other general symptoms and signs, (2) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
not applicable, no drug is used in the study. |
not applicable |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
elective surgeries
ASA 1 and 2
BMI 18.5- 29.9 |
|
ExclusionCriteria |
Details |
patients refusal
ASA 3 and 4
interincisor gap <3cm
loose teeth edentulous
TMD<6 cm
history of previous difficult intubation
BMI>30
patients requiring RSI
uncooperative
pregnant patients
patients with altered level of conciousness |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To determine the efficacy of various ultrasound measurements of upper airway in
predicting difficult laryngoscopy and intubation preoperatively
To observe whether correlation exist between different preoperative ultrasound
parameters and Intubation difficulty scale (IDS). |
The data obtained will be analysed once the study is over and a relation between the ability of ultrasound to predict a difficult intubation will be compared with actual difficult intubation |
|
Secondary Outcome
|
Outcome |
TimePoints |
To observe whether correlation exist between different preoperative ultrasound
parameters and Intubation difficulty scale (IDS). |
After intubation is over |
|
Target Sample Size
|
Total Sample Size="190" Sample Size from India="190"
Final Enrollment numbers achieved (Total)= "190"
Final Enrollment numbers achieved (India)="190" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/12/2020 |
Date of Study Completion (India) |
01/10/2021 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
01/10/2021 |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NA |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Unpredictable difficult airway remains a primary concern for anaesthesiologists. Inaccurate assessment may place the patient at risk of hypoxic events and even death if complications occur and appropriate ventilation cannot be maintained. Therefore accurate airway assessment should be performed for proper planning and management of unexpected difficult intubations .The incidence of difficult laryngoscopy and tracheal intubation still remains 1.5-13% due to poor reliability of traditional protocols, algorithms and combination of screening tools in identifying a potentially difficult airway.The commonly used screening tests like Modified Mallampatti Classification, interincisor gap, thyromental distance, neck extension, jaw protusion have shown low sensitivity and specificity with limited predictive value.
Ultrasound, due to its portable, non invasive characteristics, is useful bedside tool for airway assessment and is now widely available in operating rooms, emergency departments and criticalcare units. As the role of ultrasound in anaesthesia related airway assessment is encouraging but poorly defined , we have planned to assess its efficacy in predicting unanticipated difficult airway. A scoring system that can reliably assess difficult intubation is Intubation Difficulty Scale, which is done by direct laryngoscopy. However, laryngoscopy being an invasive procedure is difficult to perform in an awake patient, and cannot be used to predict difficult intubation.To our knowledge no study has been done to find the co relation between different preoperative ultrasound parameters and Intubation difficultyscale (IDS), hence the proporsal for this study for consideration. |