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
|
|
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
|
|
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. |