| CTRI Number |
CTRI/2016/08/007175 [Registered on: 11/08/2016] Trial Registered Retrospectively |
| Last Modified On: |
01/04/2022 |
| 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
|
Comparison of two airway devices (Ambu AuraGain with LMA ProSeal) for anaesthesia in Children. |
|
Scientific Title of Study
|
Comparison of Ambu AuraGain with LMA ProSeal in
Children under Controlled Ventilation: A Randomised Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reesha Joshi |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anesthesiology and Critical care,
Dhanvantari Nagar,
JIPMER.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
reesha.joshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Rudingwa |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anesthesiology and Critical care
Dhanvantari Nagar
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8903477132 |
| Fax |
|
| Email |
priyaab8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reesha Joshi |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anesthesiology and Critical care,
Dhanvantari Nagar,
JIPMER.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
reesha.joshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Grant For Post Graduate research
Jawaharlal Institute of Postgraduation Medical Education and Research
Dhanvantari Nagar
Puducherry 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduation Medical Education and Research |
| Address |
Dhanvantari Nagar,
JIPMER,
Puducherry 605006. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Reesha Joshi |
Jawaharlal Institute of Postgraduation Medical Education and Research |
Jawaharlal Institute of Postgraduation Medical Education and Research,
Department of Anesthesia,
Dhanvantari Nagar,
Puducherry 605006.
Pondicherry
PONDICHERRY |
7094640487
reesha.joshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ambu AuraGain |
AuraGain is a second generation single use supraglottic device promising high levels of safety and efficacy with higher oropharyngeal sealing pressure and better first attempt success rate when compared to ProSeal LMA. It will be used for procedures less than 2 hours. |
| Comparator Agent |
LMA Proseal |
It is a second generation supraglottic device with an inbuilt gastric drainage tube to empty stomach contents and was designed to provide better airway protection and airway seal pressures. They provide a peri-laryngeal seal with inflatable cuff and are an effective alternative to intubation in certain set of patients. It will be used for procedures less than 2 hours. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Children below 18years weighing between 5-30 kilograms.
2.Children undergoing inguino-scrotal or orthopedic procedure in supine position.
3.American Society of Anaesthesiologists classification 1 and 2.
|
|
| ExclusionCriteria |
| Details |
1.Anticipated difficult airway.
2.Any pathology of the neck, upper respiratory tract or upper alimentary tract.
3.Emergent surgery.
4.Active gastrointestinal reflux.
5.Active respiratory infection or lung disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the oropharyngeal seal pressure between Ambu AuraGain and ProSeal LMA in children. |
The minimum expected difference in the mean oropharyngeal leak pressure was 5 cm of H2O with a standard deviation of 7.5 cm of H2O. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the ease of insertion between Ambu AuraGain and ProSeal LMA in children. |
1-No resistance, 2-mild resistance, 3-moderate resistance, 4-unable to pass device. |
To assess and compare the time taken for successful placement between Ambu AuraGain and ProSeal LMA in children.
|
Duration in Seconds |
| To assess and compare the attempts taken for successful placement between Ambu AuraGain and ProSeal LMA in children. |
1 to 3 |
To assess and compare the ease of insertion of gastric tube between Ambu AuraGain and ProSeal LMA in children.
|
1- Easy, 2- difficult, 3- unable to pass |
| To assess and compare the fibreoptic view of larynx between Ambu AuraGain and ProSeal LMA in children. |
Brimacombe score: 1-vocal cords not seen, 2- vocal cords plus anterior epiglottis seen, 3- vocal cords plus posterior epiglottis seen, 4 – only vocal cords visible. |
| To assess and compare the incidence of complications in postoperative period between Ambu AuraGain and ProSeal LMA in children. |
Bleeding, laryngospasm, hoarseness, sore throat and cough. |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Various types of supraglottic devices are used to maintain airway and provide adequate ventilation in children undergoing surgery under general anesthesia. They can be used both for spontaneous and controlled ventilation. The second generation supraglottic devices come with an inbuilt gastric drainage tube to empty stomach contents and were designed to provide better airway protection and airway seal pressures. They provide a peri-laryngeal seal with inflatable cuff and are an effective alternative to intubation in certain set of patients. ProSeal LMA is commonly used in patients but with repeated usage the device starts leaking and might not position itself in the right place. Ambu AuraGain is a second generation single use supraglottic device promising high levels of safety and efficacy with higher oropharyngeal sealing pressure and better first attempt success rate when compared to ProSeal LMA. Ambu AuraGain is a newer single use second generation supraglottic airway device with a gastric conduit and is proposed to have a higher oropharyngeal sealing pressure compared to other laryngeal mask airways thus making it an effective ventilatory device in children undergoing minor surgical procedures. This study aims to compare the actual difference in the oropharyngeal seal pressures and the ease of insertion between ProSeal LMA and Ambu AuraGain.
The study hypothesis is that Ambu AuraGain provides better oropharyngeal sealing pressure
than ProSeal LMA in children under controlled ventilation. |