CTRI Number |
CTRI/2020/01/023050 [Registered on: 30/01/2020] Trial Registered Prospectively |
Last Modified On: |
29/07/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
This is a study to evaluate the role of ultrasound assessment of airway before surgery to predict difficulty in mask ventilation under anesthesia |
Scientific Title of Study
|
To evaluate the role of pre-operative ultrasound assessment of airway in predicting difficult mask ventilation. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Vishrantkumar k kushal shetty |
Designation |
Doctor |
Affiliation |
Maulana Azad Medical College, New Delhi. |
Address |
Dept of Anesthesia, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002 Dept of Anesthesia, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002 New Delhi DELHI 110002 India |
Phone |
9110841070 |
Fax |
|
Email |
vishranth8@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Kapil Chaudhary |
Designation |
Doctor |
Affiliation |
Maulana Azad Medical College, New Delhi. |
Address |
B L Taneja Block, Dept of Anesthesia, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002
New Delhi DELHI 110002 India |
Phone |
9871262699 |
Fax |
|
Email |
kapsdr@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Vishrantkumar k kushal shetty |
Designation |
Doctor |
Affiliation |
Maulana Azad Medical College, New Delhi. |
Address |
Dept of Anesthesia, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002 Dept of Anesthesia, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002 New Delhi DELHI 110002 India |
Phone |
9110841070 |
Fax |
|
Email |
vishranth8@gmail.com |
|
Source of Monetary or Material Support
|
Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002 |
|
Primary Sponsor
|
Name |
Maulana Azad Medical College |
Address |
Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi 110002 |
Type of Sponsor |
Government medical college |
|
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 |
Vishrantkumar K Kushal Shetty |
Maulana Azad Medical College |
Dept of Anesthesia, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002 New Delhi DELHI |
9110841070
vishranth8@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Maulana Azad Medical College |
Approved |
Maulana Azad Medical college |
Not Applicable |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
1. Patients scheduled for surgery under general anesthesia requiring mask ventilation after 1 minute of administration of neuro-muscular blockade.
2. American Society Of Anesthesiologists Physical Grade I, II, III. |
|
ExclusionCriteria |
Details |
1. Patients in whom achieving a proper mask seal
will be difficult including but not limited
to edentulous, beard, scars, swellings,
dressings over the face.
2. Patients requiring awake intubation.
3. Patients requiring rapid sequence intubation.
4. Pregnant woman.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Association between ultrasound measurement of tongue thickness to oral cavity height (TT/OCH) ratio and difficult mask ventilation (DMV).
|
During mask ventilation after 1 minute of administration of muscle relaxant. |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Association between anterior neck measurements by ultrasound and difficult mask ventilation (DMV).
2. Association between tongue thickness by ultrasound to thyromental distance ratio and DMV.
3. Comparison between prediction of DMV by known clinical parameters and ultrasound parameters.
|
During mask ventilation after 1 minute of administration of muscle relaxant. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="102" Sample Size from India="102"
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)
|
01/02/2020 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Effective mask ventilation plays a critical role in safe management of airway before intubation or after failed intubation. Failure to provide adequate oxygenation resulting from difficult mask ventilation (DMV) can lead to life threatening complications in both elective and emergency settings. Thus, it is very important to identify patients at risk of DMV. Prediction of DMV based on clinical evaluation of anesthesiologist alone is not always accurate and may lead to unanticipated DMV. This necessitates the need for diagnostic tools which may be considered adjunct to the conventional pre-operative assessment in predicting DMV and can contribute to safer airway management. During the last few years ultrasound has been used widely in the operating room for ultrasound guided procedures such as nerve block or central venous access. It has been suggested that pre-operative ultrasound measurement of airway when combined with commonly used screening tests and risk factor assessment for DMV might improve the ability to predict the difficulties. Previous studies have found the anterior neck measurements using ultrasound to be associated with DMV, especially the distance from skin to hyoid bone (DSHB). Ultrasound measurement of tongue thickness to oral cavity height ratio (TT/OCH) has been observed to be consistent with CT findings of tongue volume to oropharyngeal volume ratio and tongue thickness to oral cavity height ratio. Under general anesthesia, the tongue may obstruct the upper airway by pushing the soft palate against the posterior pharyngeal wall, obstructing both the nasal and oral cavities or the tongue may close the oral cavity when the nose is obstructed, then acting as a one-way valve obstructing expiration. Thickness of tongue relative to oral cavity height may predispose to upper airway obstruction and result in DMV. Thus, we thought it would be worthwhile to study the role of ultrasound measurement of tongue thickness to oral cavity height (TT/OCH) ratio in predicting DMV. So, we aim to evaluate the role of ultrasound guided TT/OCH ratio and anterior neck measurements in predicting DMV. |