| CTRI Number |
CTRI/2016/08/007202 [Registered on: 17/08/2016] Trial Registered Prospectively |
| Last Modified On: |
17/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Comparative Evaluation of two devices for airway patency in Children undergoing Daycare Surgery
|
|
Scientific Title of Study
|
A Comparative Evaluation of Ambu Aura Gain with ProSeal LMA in Children undergoing Daycare Surgery
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EC/02/16/965 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rachna Bhutani |
| Designation |
consultant |
| Affiliation |
SIR GANGA RAM HOSPITAL |
| Address |
J-1041
PALAM VIHAR
GURGAON
Department of anaesthesiology, pain and peri operative medicine
Sir Ganga Ram Hospital
Gurgaon
HARYANA
122017
India |
| Phone |
09811199484 |
| Fax |
|
| Email |
rachnabhutani@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rachna Bhutani |
| Designation |
consultant |
| Affiliation |
SIR GANGA RAM HOSPITAL |
| Address |
J-1041
PALAM VIHAR
GURGAON
Department of anaesthesiology, pain and peri operative medicine
Sir Ganga Ram Hospital
Gurgaon
HARYANA
122017
India |
| Phone |
09811199484 |
| Fax |
|
| Email |
rachnabhutani@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rachna Bhutani |
| Designation |
consultant |
| Affiliation |
SIR GANGA RAM HOSPITAL |
| Address |
J-1041
PALAM VIHAR
GURGAON
Department of anaesthesiology, pain and peri operative medicine
Sir Ganga Ram Hospital
Gurgaon
HARYANA
122017
India |
| Phone |
09811199484 |
| Fax |
|
| Email |
rachnabhutani@ymail.com |
|
|
Source of Monetary or Material Support
|
| SIR GANGA RAM HOSPITAL
NEW RAJINDER NAGAR
NEW DELHI |
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram Hospital |
| Address |
Department of Anaesthesiology
SIR GANGA RAM HOSPITAL
NEW RAJINDER NAGAR
NEW DELHI |
| 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 Rachna Bhutani |
Operating Room,Sir Ganga Ram Hospital |
New Rajinder Nagar
New Delhi
New Delhi
DELHI |
09811199484
rachnabhutani@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Sir Ganga Ram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Paediatric patients for day care surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ambu aura gain |
After randomization and following standard induction, the airway of the patients in this group will be secured with Ambu aura gain.
following parameters will be compared with comparator group
1.ease of insertion
2.number of attempts
3.fiberoptic glottic view
4.duration of the surgery
5.oro pharyngeal seal pressures. |
| Comparator Agent |
Pro seal laryngeal mask airway |
After randomization , following standard induction , the airway of the patient will be secured with proseal laryngeal airway.
following parameters were documented
1.ease of insertion
2.number of attempts
3.fiberoptic glottic view
4.duration of the surgery
5.oro pharyngeal seal pressures. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA I to II children
2.Elective daycare procedure under general anaesthesia
3. weight 5 to 30kg. |
|
| ExclusionCriteria |
| Details |
1. ASA III / IV
2.Parent / guardian refusal
3.Patient not fulfilling ASA fasting guideline
4.Head and neck surgery and difficult airway
5.Children with sore throat or upper respiratory infection
ï‚· Position other than supine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the oropharyngeal seal pressure (OSP) |
To compare the oropharyngeal seal pressure (OSP) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Ease of insertion
2.Insertion time
3.Number of attempts
4. Fibreoptic laryngeal view
5. Intraoperative and postoperative complications |
From induction of anaesthesia to till the patient is discharged home from the daycare unit |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2016 |
| Date of Study Completion (India) |
28/02/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
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
|
The second generation supraglottic airway devices(SAD) are widely used in paediatric population. The improved features of these devices providing better airway seal and their ability to remove gastric contents have revolutionized airway management in paediatric anaesthetic practice. ProSeal Laryngeal Mask Airway (PLMA), a SAD with a gastric drain tube, has been widely used in paediatric patients under controlled ventilation. The Ambu Aura Gain is another SAD (a modification of previous supraglottic device Ambu Aura Once) which is designed to facilitate guided tracheal intubation. It has integrated gastric access channel for managing gastric contents and provides higher oropharyngeal seal pressure (OSP). It has original anatomical curve ensuring rapid placement and intubating capacity using standard endotracheal tubes. It is MRI safe and is made up of phthalate free material. It is available in paediatric sizes also. The aim of this prospective randomized study is to evaluate and compare suitability of Ambu Aura Gain as an airway device with the PLMA in paediatric daycare surgery. |