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CTRI Number  CTRI/2024/01/061839 [Registered on: 25/01/2024] Trial Registered Prospectively
Last Modified On: 12/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A Study to measure various structures of mouth and throat using ultrasound for the placement of ProSeal LMA 
Scientific Title of Study   Evaluation of ultrasound guided airway parameters for placement of ProSeal LMA- An 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  Dr Kirti Kshetrapal 
Designation  Professor  
Affiliation  Pt B D Sharma PGIMS Rohtak  
Address  Department of Anaesthesiology and Critical Care, PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9215650615  
Fax    
Email  kamalkirti47@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Priya 
Designation  Postgraduate student 
Affiliation  Pt B D Sharma PGIMS Rohtak  
Address  Department of Anaesthesiology and Critical Care, PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9671467779  
Fax    
Email  priya.sharma2407g@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Priya 
Designation  Postgraduate student 
Affiliation  Pt B D Sharma PGIMS Rohtak  
Address  Department of Anaesthesiology and Critical Care, PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9671467779  
Fax    
Email  priya.sharma2407g@gmail.com  
 
Source of Monetary or Material Support  
Pt B D Sharma, PGIMS Rohtak 
 
Primary Sponsor  
Name  Pt B D Sharma PGIMS Rohtak  
Address  Department of Anaesthesiology and critical care, PGIMS, Rohtak, Haryana, 124001, INDIA 
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 Priya  Pt B D Sharma PGIMS Rohtak   Department of Anaesthesiology and Critical Care
Rohtak
HARYANA 
9671467779

priya.sharma2407g@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research ethicsl committee, Pt B D Sharma PGIMS Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged between 20-60 years of age, of either gender, belonging to American Society of Anaesthesiologists (ASA) physical status I and II, scheduled for elective surgery under general anaesthesia requiring ProSeal LMA insertion. 
 
ExclusionCriteria 
Details  Patients with
Refusal to participate
Pharyngeal pathology
Gastroesophageal reflux
Low pulmonary compliance
Severe Cardio vascular disease
BMI more than or equal to thirty-five kilogram per metersquare
Facial and tongue anomalies or any other airway anomaly
Temporo-mandibular joint ankylosis
Oropharyngeal pathology
History of obstructive sleep apnoea 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the role of preoperative ultrasound measured airway parameters in guiding optimal placement of ProSeal LMA using fiberoptic grading.  immediately after ProSeal LMA placement 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the correlation between ultrasound measured pre-operative airway parameters and
1. Ease of mask ventilation.
2. Ease of insertion of ProSeal LMA.
3. Time taken for ProSeal LMA placement. 
while placement of ProSeal LMA 
 
Target Sample Size   Total Sample Size="95"
Sample Size from India="95" 
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)   05/02/2024 
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)
Modification(s)  
Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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
Modification(s)  
Airway management is a core component of anaesthesia care. In any procedure that requires general anaesthesia, anaesthesiologists need to control the patient‟s airway in order to maintain adequate ventilation and oxygenation. This can be a high-risk task and can lead to patient morbidity and mortality, due to inadequate/impossible ventilation, and/or intubation. Therefore, it is essential to optimize methods to anticipate a difficult airway and ensure the necessary means to intervene.
As per American Society of Anaesthesiologists (ASA) 2022 guidelines, a difficult airway includes the clinical situation in which anticipated or unanticipated difficulty or failure is seen by an experienced anaesthesiologist during facemask ventilation, laryngoscopy, ventilation using a supraglottic airway, tracheal intubation, extubation or invasive airway. Difficult supraglottic airway ventilation is defined as when it is not possible to provide adequate ventilation because of difficult supraglottic airway placement, supraglottic airway placement requiring multiple attempts, inadequate supraglottic airway seal, excessive gas leak, or excessive resistance to the ingress or egress of gas. Inability to anticipate difficult airway and thereby poor planning for airway management remains the primary cause of airway related complications for anaesthesiologists. Difficult airway is a potential risk in few patients which is associated with serious morbidity and mortality and poses a challenge for anaesthesiologists. There have been many techniques devised to assess difficult airways like modified mallampati test, thyromental distance, hyomental distance, inter incisor distance, neck movements and neck circumference. All these methods are subjective to the observer and require mandatory actions to be performed by the patients which decrease its application especially in unconscious patients. Also they have less sensitivity and specificity with a limited predictive value. Despite using all the available clinical parameters of airway assessment, in many cases a difficult airway may be undiagnosed preoperatively and we may land up in a situation of can’t intubate, can’t ventilate during intubation and anaesthesia.
During the last few years ultrasound has been widely used in the operating room for ultrasound-guided procedures such as nerve block or central venous access. Ultrasound provides quick, relatively easy, and accurate information, with diagnostic and therapeutic relevance. For some considerable time ultrasound has not been taken into consideration as a tool for the evaluation of the airway or as a predictor of difficult laryngoscopy. Pre-operative ultrasound measurement of the anterior neck soft-tissue thickness at different levels, combined with the commonly used screening tests and risk factor assessment for difficult laryngoscopy might improve the ability to predict difficult laryngoscopy.
The ASA has included ultrasound in pre-operative airway assessment in its guidelines for management of difficult airway 2022 and parameters included were skin-to-hyoid distance, tongue volume, and distance from the skin to the epiglottis. So, Ultrasonography is emerging as a new technique for difficult airway assessment as it is simple, convenient and non- invasive, has no risk of radiation exposure, and because it is portable, it can be used to assess airway bedside along with clinical parameters. Some studies are available to assess the usefulness of pre-operatively measured ultrasonographic airway parameters to predict difficult laryngoscopy and difficult tracheal intubation. A metanalysis had concluded that hyomental distance in neutral head position was the most consistent pre-operative ultrasound measured airway parameter to predict difficult laryngoscopy and difficult tracheal intubation.
 
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