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CTRI Number  CTRI/2023/12/060734 [Registered on: 26/12/2023] Trial Registered Prospectively
Last Modified On: 23/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two techniques of LMA insertion in paediatric population (standard and reverse technique) 
Scientific Title of Study   A prospective randomized study to compare standard versus reverse insertion techniques of classic LMA in paediatric patients.  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kuldeep Sahay 
Designation  Junior Resident 
Affiliation  Uttar pradesh university of medical sciences saifai, etawah 
Address  Room number- 329 Department of Anaesthesiology and Critical Care,UPUMS,Saifai, Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  9458053701  
Fax    
Email  kuldeeptheguru@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Atit Kumar 
Designation  Additional Professor 
Affiliation  Uttar pradesh medical sciences saifai,etawah 
Address  Room number- 329 U.P.University of medical sciences,saifai, Etawah (UP) 206130

Etawah
UTTAR PRADESH
206130
India 
Phone  9453471671  
Fax    
Email  dr_atit@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Kuldeep Sahay 
Designation  Junior Resident  
Affiliation  Uttar pradesh medical sciences saifai,etawah 
Address  Room number- 329 Department of Anaesthesiology and Critical Care, UPUMS, Saifai, Etawah.

Etawah
UTTAR PRADESH
206130
India 
Phone  9458053701  
Fax    
Email  kuldeeptheguru@gmail.com  
 
Source of Monetary or Material Support  
Uttar pradesh university of medical sceinces Saifai Etawah 
 
Primary Sponsor  
Name  Uttar pradesh university of medical sceinces saifai etawah 
Address  UPUMS Saifai etawah pincode 206130 
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 
Kuldeep Sahay  Uttar Pradesh University of Medical Sciences  Room no.329, Department of Anaesthesiology and critical care,UPUMS, Saifai, Etawah, Uttar Pradesh. Pin code- 206130
Etawah
UTTAR PRADESH 		 9458053701

kuldeeptheguru@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Uttar Pradesh University of medical sciences saifai.Etawah  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Reverse technique  Classic LMA will be inserted by using Reverse technique and Number of attempt, time to secure successful airway will be noted. Haemodynamic monitoring will be done for 1hr. 
Comparator Agent  Standard technique   Classic LMA will be inserted by using Standard technique and Number of attempt, time to secure successful airway will be noted. Haemodynamic monitoring will be done for 1hr. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.Weight 15 - 30 kg.
2.American society of anesthesiology (ASA) Physical status class I and class II.
3.Duration of surgery less than 60 minutes.
 
 
ExclusionCriteria 
Details  1.Patients attendants refusing for participation.
2.Risk of aspiration (full stomach, gastroesophageal reflex disease,).
3.Inadequate mouth opening.
4.Any oral pathology.
5.Suspected difficult airway.
6.Surgery >60 minutes.
7.Age < 5 year or > 10 year.
8.Patients with any congenital anomaly.
9.Any emergency surgery.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Number of attempts.
Time to secure successful Airway. 		 Base line, 1 min, 3 min, 5 min, there after every 5 min till successful airway is achieved.  
 
Secondary Outcome  
Outcome  TimePoints 
Comparision of heamodynamic parameters.
Comparision of complication.
Failure rate.
 		 From 0 minutes to 60 minutes. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 4 
Date of First Enrollment (India)   10/01/2024 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [kuldeeptheguru@gmail.com].

  6. For how long will this data be available start date provided 01-07-2025 and end date provided 30-06-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Title of this study is A prospective randomized study to compare standard versus reverse insertion techniques of classic LMA in paediatric patients. Laryngeal Mask Airway (LMA) is a supraglottic airway device that is designed to seal around the laryngeal inlet. It can be inserted into the pharynx to allow ventilation, oxygenation, and administration of anesthetic gases, without the need for endotracheal intubation.  LMA is frequently used for airway management in paediatrics age group. LMA is a safer and reliable alternative rescue device in both elective and emergency situations for both anticipated and unanticipated difficult airway. LMA is made from silicon and contain no latex. It is a reusable device and may be steam autoclaved up to 40 times.

Various methods and techniques have been described regarding the insertion of LMA. The most primordial technique is standard technique or digital technique. The another technique which is quite popular is reverse technique. In this study, we compared these two techniques of classic LMA insertion in terms of insertion, Number of attempt, hemodynamic and overall success rate and incidence of complications if any.  In this study we take all patient visiting for surgery less than 60 minutes at UPUMS, Saifai (U.P.) Patients above 5year and less then 10 years of age. 

Aim of this study to Compare of standard versus reverse insertion techniques of classic LMA in paediatric  patients.

Obective of this study to evaluate and compare the ease of classic LMA insertion through the standard or reverse techniques with respect to  number of attempts, Time to secure successful airway.

We will perform a prospective randomized study. In this study will we compared two techniques of classic LMA insertion (Standard versus Reverse) in terms of insertion, Number of attempt, hemodynamic and overall success rate and incidence of complications if any.

Outcome Measures of  this study is to measures hemodynamic parameters HR, SBP,DBP,MAP,SPO2 in view of   total number of attempt and total time to secure successful placement of airway.

 



 

 

 

 


 

 
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