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CTRI Number  CTRI/2024/03/064114 [Registered on: 14/03/2024] Trial Registered Prospectively
Last Modified On: 13/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Understanding the Benefits of Airway Ultrasound After Surgery 
Scientific Title of Study   Evaluating Airway Ultrasound Parameters For Predicting Extubation Readiness, And Risk Of Post-Operative Respiratory Failure- A Prospective Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhavna Gupta 
Designation  Associate Professor 
Affiliation  All India Institute Of Medical Sciences Rishikesh 
Address  Department Of Anaesthesia, Level 6, All India Institute of Medical Sciences Veerbhadra Marg Rishikesh Uttarkashi Uttaranchal

Dehradun
UTTARANCHAL
249203
India 
Phone  8527686660  
Fax    
Email  bhavna.kakkar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bhavna Gupta 
Designation  Associate Professor 
Affiliation  All India Institute Of Medical Sciences Rishikesh 
Address  Department Of Anaesthesia, Level 6, All India Institute of Medical Sciences Veerbhadra Marg Rishikesh Uttarkashi Uttaranchal

Dehradun
UTTARANCHAL
249203
India 
Phone  8527686660  
Fax    
Email  bhavna.kakkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Parag Aneja 
Designation  Post graduate resident 
Affiliation  All India Institute Of Medical Sciences Rishikesh 
Address  Department Of Anaesthesia, Level 6, All India Institute of Medical Sciences Veerbhadra Marg Rishikesh Uttarkashi Uttaranchal

Dehradun
UTTARANCHAL
249203
India 
Phone  9814806666  
Fax    
Email  paraganeja14@gmail.com  
 
Source of Monetary or Material Support  
none 
 
Primary Sponsor  
Name  AIIMS Rishikesh 
Address  Veer Bhadra Marg Rishikesh Uttarakhand 249203 
Type of Sponsor  Government medical college 
 
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 
Dr Parag Aneja  AIIMS Hospital  Department Of Anaesthesia Level 6, Academic Block All India Institute of Medical Sciences, Veerbhadra Marg Rishikesh Uttarkashi Uttaranchal
Dehradun
UTTARANCHAL 		 9814806666

paraganeja14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  undergoing surgery under general anesthesia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age ≥ 18 years and ≤ 65 years, BMI≤30 kg/m2, American Society of Anesthesiologists (ASA) grading I-II, Undergoing elective surgery with general anaesthesia and endotracheal intubation and providing Consent to participate
 
 
ExclusionCriteria 
Details  Pregnant women, Patients with predicted difficult airway, Patients with abnormal pharynx or laryngeal anatomy, Patients with severe cardiovascular or pulmonary diseases, hepatic or renal dysfunction, Patients with preoperative coagulation disorders, Surgery done in prone position, Refusal to participate
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the predictive accuracy of ultrasound guided laryngeal column width compared to traditional extubation readiness criteria (cuff leak test).  Post induction, Prior to extubation 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the predictive accuracy of other airway ultrasound parameters in conjunction with traditional extubation readiness criteria.
To assess whether pre-anesthetic ultrasound measurements can serve as predictive markers for the risk of post-operative respiratory failure.
To accurately measure delta changes in ultrasound airway parameters post induction from baseline parameters.
Co relation of airway ultra sonographic parameters with BIS values
 		 Pre operatively, after pre oxygenation, post induction, every hour till end of surgery, prior to extubation, post operative period 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   23/03/2024 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study will be held at Department Of Anaesthesiology at All Institute Of Medical Sciences, Risikesh. The primary objective of this study is to compare the predictive accuracy of ultrasound guided laryngeal column width compared to traditional extubation readiness criteria (cuff leak test).
The hypothesis is that ultrasound measurements of the upper and laryngeal airway can serve as predictive markers for the extubation readiness and predicting risk of post-operative complications like stridor or respiratory failure.
 
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