| CTRI Number |
CTRI/2023/07/055505 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
19/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare two types of airway devices proseal LMA and i-gel in children undergoing elective surgical procedures |
|
Scientific Title of Study
|
To compare the safety & efficacy of ProsealLMA versus i-gel in children undergoing elective surgery under spontaneous ventilation: A randomized control trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anisha Pauline L |
| Designation |
PG Registrar |
| Affiliation |
The Tamilnadu Dr.M.G.R Medical University |
| Address |
Department of Anaesthesiology
Christian medical college
Vellore
Christian Medical College
Ida Scudder Road
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9445652668 |
| Fax |
|
| Email |
anishalionel11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ekta Rai |
| Designation |
Head of Department of Anaesthesiology |
| Affiliation |
The Tamilnadu Dr.M.G.R Medical University |
| Address |
Department of Anaesthesiology
Christian Medical College
Ida Scudder Road
Vellore
Christian Medical College
Ida Scudder Road
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9789250113 |
| Fax |
|
| Email |
drektarai@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Anisha Pauline L |
| Designation |
PG Registrar |
| Affiliation |
The Tamilnadu Dr.M.G.R Medical University |
| Address |
Department of Anaesthesiology
Christian Medical College
Ida Scudder Road
Vellore
Christian Medical College
Ida Scudder Road
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9445652668 |
| Fax |
|
| Email |
anishalionel11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Internal - Fluid Research Grant,Christian medical college,vellore |
|
|
Primary Sponsor
|
| Name |
Anisha Pauline L |
| Address |
Dr.Anisha Pauline L
Department of Anaesthesiology
Christian Medical college
Vellore
Tamil Nadu |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Anisha Pauline L |
Christian Medical college |
Department of Anaesthesiology
Vellore
TAMIL NADU |
9445652668
anishalionel11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board and Ethics Committee of Christian Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children of 1 -10 years undergoing elective surgeries less than 2 hrs |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
i-gel |
i-gel (Intersurgical,Wokingham,Berkshire,UK) is a second generation supraglottic airway device. It was invented by Muhammed Nasir in 2003.It is cuffless with a gastric channel. It is made of a thermoplastic elastomer called SEBS(Styrene Ethylene Butadiene Styrene).It has a special property to conform according to the patient’s anatomy of hypopharynx after its placement. It is due to the expansion of elastomer which is activated by the body temperature. It is a single use device. It has additional features such as epiglottic rest, buccal cavity stabilizer and bite block. It can be used as a conduit for intubation. It’s advantages include prevention of rotation due to buccal cavity stabiliser, prevents downfolding of epiglottis, and airway obstruction |
| Intervention |
ProsealLMA |
Proseal–LMA{LMA-PROSEAL, PLMA} is a second generation supraglottic device. It is a reusable device.It reduces the risk of gastric insufflations and pulmonary aspiration.It has six sizes(1.5,2,2.5,3,4,5).It has both dorsal and ventral cuff.Proseal-LMA sizes 1.5,2 and 2.5 doesn’t have dorsal cuff.The ventral cuff is larger and provides good seal. It also has a bite block where the teeth contact the LMA. It is flexible due to wire reinforcement in airway tube.It has an accessory vent to prevent secretions from pooling.After placement the cuff tip lies behind the cricoid cartilage at the origin of esophagus |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA grade I and II.
2) Children of either sex aged 1-10 years
3) BMI<30
4) Mouth opening of more than 2.5cm.
5) Elective lower abdominal, minor urological and minororthopaedic surgeries of duration less than 120minutes, such as circumcision, orchidopexy, herniotomy, urethroplasty,implant exit in upper limb and lower limb
|
|
| ExclusionCriteria |
| Details |
1)Parent/Guardian refusal
2)Patients with active upper/lower respiratory tract
infections.
3) Patients at risk of aspiration.
4) Patients with known systemic or syndromic comorbidities.
5) Patients with airway abnormalities, loose teeth.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oropharyngeal leak pressure & successful placement meeting all 5 criteria of
tidal volumes more than 6 ml per kg
bilateral equal chest rise
EtCO2 waveform of 30 to 35 mmHg
no peak pressure elevation more than 30 cm H2O
with no audible leak |
Within 10 minutes of jntubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ease of insertion
Ease of gastric tube placement
Incidence of larngospasm
Incidence of Bloodstained LMA after extubation
Incidence of sorethroat,hoarse cry,or any other discomfort in throat postoperatively |
Intraoperative & postoperative period |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 3 |
|
Date of First Enrollment (India)
|
01/08/2023 |
| 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="6"
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 - NO
|
|
Brief Summary
|
The Laryngeal mask airways are supraglottic airway devices that has gained popularity over years in managing difficult airway,nonoperating room anaesthesia,day care surgeries,ophthalmologic surgeries, etc.These devices have been designed to provide and maintain seal around laryngeal inlet and are considered effective alternatives to endotracheal tube. The relatively newer second generation such as LMAs such as proseal LMA and i-gel are used widely in children. The objective of this study is to compare the efficacy and safety of their use in paediatric population undergoing elective surgeries in terms of successful airway placement,oropharyngeal leak pressure, gastric tube insertion, ease of insertion and complications anticipated during spontaneous ventilation and postoperatively All children aged between 1 to 10years scheduled for elective surgeries with duration less than 2hr,BMI<30 and with ASA physical status of I and II meeting the inclusion criteria will be included. After informed consent, eligible patients will be advised fasting orders for solids and liquids and will be randomly allocated on the day of surgery by opaque envelope concealment method. After securing a good intravenous access after inhalational induction and connecting ASA standard monitors, the child will be deepened for LMA insertion with intravenous agents like fentanyl (1-2 mcg/kg)and propofol (1-2 mg/kg).The successful placement of LMA will be assessed on ease of insertion of LMA ,acquiring adequate tidal volumes, oropharyngeal leak pressure, ease of gastric tube insertion, any laryngospasm during induction and maintenance will be observed and after extubation staining of LMA with blood and sore throat ,hoarse cry,discomfort in throat will be observed in postanaesthesia care unit. There are very few studies comparing proseal LMA and i-gel in paediatric population under spontaneous ventilation.Proseal LMA is considered as standard of care and from this study if i-gel proves to be noninferior to Proseal LMA,it may be used alternatively in future elective surgical day to day practices. |