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CTRI Number  CTRI/2022/03/041536 [Registered on: 31/03/2022] Trial Registered Prospectively
Last Modified On: 30/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Whether pre-operative airway assessment tests can predict difficult insertion and suboptimal position of Proseal LMA 
Scientific Title of Study   Evaluation of different preoperative bedside airway assessment tests to determine ease of insertion of Proseal LMA 
Trial Acronym   
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  Senior Professor 
Affiliation  Pt B.D Sharma PGIMS Rohtak 
Address  Department of anesthesiology and critical care,PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9215650615  
Fax    
Email  kamalkirti47@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ivneet kaur 
Designation  Post graduate student 
Affiliation  Pt B.D Sharma PGIMS Rohtak 
Address  Department of anesthesiology and critical care PGIMS ROHTAK

Rohtak
HARYANA
124001
India 
Phone  8053879667  
Fax    
Email  Ivneet270695@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ivneet kaur 
Designation  Post graduate student 
Affiliation  Pt B.D Sharma PGIMS Rohtak 
Address  Department of anesthesiology and critical care, PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  8053879667  
Fax    
Email  Ivneet270695@gmail.com  
 
Source of Monetary or Material Support  
Department of anesthesiology and critical care,MOT and ICU complex,PT BD Sharma,PGIMS ROHTAK 
 
Primary Sponsor  
Name  Department of anaesthesiology PGIMS ROHTAK 
Address  MOT and ICU complex,department of anesthesiology PGIMS ROHTAK 
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 ivneet kaur  PGIMS ROHTAK  MOTand ICU complex, Department of anesthesiology and critical care PGIMS ROHTAK
Rohtak
HARYANA 		 8053879667

Ivneet270695@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research ethics committee,Pt. BD Sharma PGIMS Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Patient  Aged 20-50 yrs going for elective surgery under GA requiring PLMA 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients aged between 20-50 years of age of either sex belonging to ASA I and II scheduled for elective surgery under GA requiring LMA insertion 
 
ExclusionCriteria 
Details  Pts with pharyngeal pathology
Aspiration risk
Low pulmonary compliance
Severe cardiovascular disease
Cervical spine injury
GERD
Poor/loose dentition
Intra/oral mass tumor
TMJ ankylosis
Mouth opening≤3cms
Facial and tongue anomalies
OSA
Who refuse to participate 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine accuracy of pre-operative bedside airway assessment tests for predicting Proseal LMA placement as judged b fibreoptic grading  Fibreoptic scoring will be done after PLMA placement 
 
Secondary Outcome  
Outcome  TimePoints 
To determine correlation of pre-operative bedside airway assessment test for
1.success/failure of PLMA placement
2.number of attempts
3.Time taken for PLMA placement 		 Time will be noted during placement 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   31/03/2022 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [Ivneet270695@gmail.com].

  6. For how long will this data be available start date provided 28-12-2022 and end date provided 30-12-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The relevance of various bedside airway assessment will give us an idea of ease of insertion of PLMA patients undergoing elective surgery.Fibreoptic scoring will be used as a guide for after insertion . 
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