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CTRI Number  CTRI/2025/08/092207 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Comparison of clinical method and ultrasound to confirm correct placement of breathing device(Laryngeal Mask Airway Blockbuster) during Anaesthesia  
Scientific Title of Study   To compare clinical versus ultrasound assessment for correct placement of Laryngeal Mask Airway Blockbuster: A randomized prospective 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  Dr Shivi Mishra  
Designation  PG junior resident 1 
Affiliation  Government Institute Of Medical Sciences  
Address  S2-1608,Supertech Czar, Omicron-1, Greater Noida
near Gautam Buddha University (Delhi NCR, Kasna Village, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  8795280836  
Fax    
Email  mishrashivi.sm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nazia Nazir 
Designation  Professor  
Affiliation  Government Institute Of Medical Sciences  
Address  Department of Anaesthesia, 1st floor, OT Complex, GIMS, Greater Noida
near Gautam Buddha University (Delhi NCR, Kasna Village, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9560102957  
Fax    
Email  nazunazir@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shivi Mishra  
Designation  PG junior resident 1 
Affiliation  Government Institute Of Medical Sciences  
Address  S2-1608,Supertech Czar, Omicron-1, Greater Noida
near Gautam Buddha University (Delhi NCR, Kasna Village, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  8795280836  
Fax    
Email  mishrashivi.sm@gmail.com  
 
Source of Monetary or Material Support  
Government Institute of Medical Sciences, Kasna, Greater Noida, GBN, Uttar Pradesh, India, 201310 
 
Primary Sponsor  
Name  Government Institute of Medical Sciences  
Address  Government Institute of Medical Sciences, Kasna, Greater Noida, GBN, Uttar Pradesh, India, 201310 
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 Shivi Mishra   Government Institute of Medical Sciences   Department of Anaesthesia, 1st floor, OT Complex, GIMS, Kasna, Greater Noida.
Gautam Buddha Nagar
UTTAR PRADESH 
8795280836

mishrashivi.sm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K805||Calculus of bile duct without cholangitis or cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of American Society of Anaesthesiologists (ASA) physical status I&II, Age 18.5-60 years, BMI 18-30 kg/m2 Undergoing elective surgery under general anaesthesia in the supine position.
 
 
ExclusionCriteria 
Details  Patients with
History of difficult airway,
history of airway stenosis, airway mass,
hyperthyroidism, goitre,
carotid stenosis,
gastroesophageal reflux, aspiration, and
• history of neck surgery.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare clinical versus ultrasound assessment for correct placement of Laryngeal Mask Airway (LMA) Blockbuster in adult patients undergoing elective surgery under general anaesthesia.   5 mins, 10 mins, 20 mins, 30 mins 
 
Secondary Outcome  
Outcome  TimePoints 
1. To measure and compare the average peak inspiratory pressure during inspiration in both the groups.
2.To measure total time taken for assessment of correct placement of LMA Blockbuster by each method.
 
5 mins, 10 mins, 20 mins, 30 mins.  
 
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)   01/08/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

The development of supraglottic airway devices (SADs) has revolutionized airway management during general anesthesia. The use of SADs is now standard in airway management technique, and they fill the niche between the face mask and tracheal tube in terms of both airway anatomy and degree of invasion. Anesthesiologists need an effective and reliable method to confirm LMA placement definitively without interrupting ventilation. Ultrasound is noninvasive, and can be a reliable means of assessing the correct placement of SADs [1-3]. The laryngeal mask airway (LMA) is widely used as they are easier to insert than an endotracheal tube, but there is a greater likelihood of misplacement. Anaesthesiologists may not always be able to confirm the exact position of an LMA promptly, potentially resulting in inadequate ventilation, and in turn resulting in need for reinsertion. To avoid these complications, it is essential to be able to determine the reason for inadequate ventilation quickly. Current methods to assess LMA placement include the following: auscultation, the leakage test, insertion of a suction tube into the drainage conduit, the bubble test, and fiberoptic examination [2, 3, 7]. While these techniques are simple and widely used, in recent years, point-of-care ultrasound (POCUS) has emerged as a promising non-invasive tool for real-time airway assessment.

 
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