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CTRI Number  CTRI/2018/01/011135 [Registered on: 04/01/2018] Trial Registered Retrospectively
Last Modified On: 03/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparing two different techniques for laryngeal mask airway size selection 
Scientific Title of Study   A prospective randomised study comparing the standard weight based technique and a novel technique based on combined width of index, middle and ring fingers for proseal laryngeal mask airway size selection in Indian paediatric patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sahana H 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal University 
Address  Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9663863186  
Fax    
Email  sahanavasista@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shaji Mathew 
Designation  Associate Professor 
Affiliation  Kasturba medical college, Manipal university 
Address  Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9449388791  
Fax    
Email  shajimanipal@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Yogesh Gaude 
Designation  Assistant Professor 
Affiliation  Kasturba medical college, Manipal university 
Address  Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8904380406  
Fax    
Email  yogeshgaude@gmail.com  
 
Source of Monetary or Material Support  
PG Thesis fund , Manipal University, Manipal,Karnataka , India.PIN 576104 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Private 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 Sahana H  Kasturba Hospital, Manipal   Department of Anaesthesiology, OT Complex, Kasturba Hospital,Manipal University, Madhavnagr, Manipal
Udupi
KARNATAKA 
9663863186

sahanavasista@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Hospital, Manipal   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA physical status 1 and 2,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group N : Novel group  PLMA size selected based on finger breadth of the patients. This method consists of extending the right hand of each patient with palm facing up and hand opened separating the thumb and little finger, keeping the second, third and fourth fingers extended but together. Laryngeal masks of different sizes were inflated with maximum volume of air as per the manufacturer’s recommendation. Then ventral surface of the laryngeal mask airway will be applied against palmar side of second, third and fourth fingers held in approximation. The PLMA that best fits with the width of these three fingers would then be choosen. 
Comparator Agent  Group s: Standard group  PLMA size selected based on standard weight based calculation 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  10.00 Year(s)
Gender  Both 
Details  All paediatric patients undergoing elective surgical procedures of short duration (< 1-2 hour) like circumcision, open herniotomies, anal dilatation, urethral dilatation, open hernia repair etc., requiring general anaesthesia.
(a) Age: 6 months to 10 years
(b) Weighing between 5-30 kg
(c) American Society of Anesthesiologists Physical Status I and II
(d) Parents of children willing to comply with informed written consent
 
 
ExclusionCriteria 
Details  1.Patients not belonging to above mentioned age and ASA status.
2.Patient’s / parental refusal to participate.
3.Ex-preterm infants.
4.Emergency surgeries and patients with history of hiatus hernia.
5.Patients with history of obstructive sleep apnoea, asthma, congenital heart disease, obesity, mental retardation.
6.Recent history of respiratory tract infection.
7.Children requiring rapid sequence induction.
8.Children with unstable cervical spine or limited neck mobility.
9.Children with cleft palate of any degree.
10.Anticipated difficult airway.
11.Complete upper airway obstruction.
12.Suspected or known abnormalities of the airway.
13.Morbid obesity.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Placement of ProSeal LMA  During induction of anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  No 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/10/2015 
Date of Study Completion (India) 15/07/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Yet..We are preparing the Manuscript for publication.. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The  Laryngeal mask airway has emerged as a formidable choice over endotracheal in scenarios where endotracheal intubation is not mandatory.1 Compared with the face mask, the LMA allows for a more “hands-free approach” to airway management.2 The laryngeal mask airway is intended to be placed over the laryngeal inlet, is considered to be an intermediate between endotracheal tube and oropharyngeal airway in terms of invasiveness and offers some of the advantages of endotracheal intubation while surpassing the disadvantages like stimulation of the laryngopharyngeal reflex.2 An endotracheal tube (ET) is always considered to be the gold standard in airway management3, 4,  is a device to maintain a patent airway because of ability to provide positive pressure ventilation (PPV) through it and to prevent of gastric inflation and pulmonary aspiration.4 Adverse haemodynamic responses, situations of failed intubation and injury to the oropharyngeal structures4 during intubation are also a serious concern.

The ProSeal LMA (PLMA) was introduced by Dr Archie Brain in 2000.5 ProSeal LMA has a channel for gastric drainage, placed by the side of the main airway tube. A gastric tube can be passed through the drainage channel and can detect malposition6 of PLMA. The paediatric PLMA lacks dorsal cuff 6 and is available in sizes 1, 1.5, 2 and 2.5.

In clinical practice, most commonly used method for size estimation is weight based calculation, which may not be suitable in many patients because of wide range for each category of weight. Many anaesthesiologists choose an orotracheal tube approximately equal to the size of the little finger of the child. Although this estimation may be imprecise and unreliable, it provides an approximation of the size of tube required. No analogous methods exist for rough estimation of the required laryngeal mask airway size.7

              

The aim of current study is to determine whether combined width of patient’s index, middle and ring fingers could be used as a proxy for appropriate size of laryngeal mask airway to be used in children as an alternative in those situations where patient’s weight is unknown. 8,9 This technique should be easy to perform, easy to remember and accurate in determining the size of the laryngeal mask airway and applicable at patient’s bedside. The new method proposed relates to the anatomic features of patient and fulfils all these requirements. To validate this procedure, the size of the laryngeal mask airway determined with this method will be compared with size according to patient’s weight.

Final Summary: To conclude, weight based method and novel method for the selection of ProSeal laryngeal mask airway in pediatric patients are in moderate level of agreement. Ease of insertion, number of attempts, visualization of glottis with fiberoptic bronchoscope and ease of gastric tube insertion are comparable in both groups. Novel method can be used as a good alternative to standard weight based method for the selection of ProSeal laryngeal mask airway when weight is unknown.

 
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