| CTRI Number |
CTRI/2018/03/012836 [Registered on: 26/03/2018] Trial Registered Prospectively |
| Last Modified On: |
23/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effectiveness of two supraglottic airway devices Ambu® AuraGain™ laryngeal mask airway with LMA ProSeal ™ in patients undergoing laparoscopic surgeries. |
|
Scientific Title of Study
|
A randomised clinical trial comparing the effectiveness of Ambu® AuraGain™ laryngeal mask airway with LMA ProSeal ™ in patients undergoing laparoscopic surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manisha M K |
| Designation |
Post graduate first year |
| Affiliation |
SDM medical college |
| Address |
Dept of Anaesthesia,SDM medical college Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9845607562 |
| Fax |
|
| Email |
manishamk91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Bharadwaj |
| Designation |
Assistant professor |
| Affiliation |
SDM medical college |
| Address |
Dept of Anaesthesia,SDM medical college Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9886468625 |
| Fax |
|
| Email |
archana.a.b16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana Bharadwaj |
| Designation |
Assistant professor |
| Affiliation |
SDM medical college |
| Address |
Dept of Anaesthesia,SDM medical college Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9886468625 |
| Fax |
|
| Email |
archana.a.b16@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM medical college , manjushree nagar, Sattur,Dharwad - 580009 |
|
|
Primary Sponsor
|
| Name |
SDM Medical collegeDharwad |
| Address |
SDM medical college,Sattur, Dharwad |
| 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 manisha |
sdm medical college karnataka |
Main operation theatre complex , sdm medical college, manjushree nagar, Sattur, Dharwad- 580009
Dharwad
KARNATAKA |
9845607562
manishamk91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, ASA physical status I and II patients scheduled for laparoscopic surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ambu® AuraGain™ laryngeal mask airway |
new second generation Supraglottic airway device |
| Comparator Agent |
LMA ProSealâ„¢ |
second generation Supragottic airway device |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are undergoing elective laparoscopic surgeries
2.Age:18-65years
3.ASA physical status I and II
4.Those willing to participate
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.ASA physical status III and IV
3.Obesity BMI>30 kilograms per meter square
4.Pregnancy
5.High risk of pulmonary aspiration , inadequate fasting, gastro-esophageal reflux disease (GERD)
•Restricted mouth opening
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oropharyngeal leak pressure and mucosal pressure
|
Oropharyngeal leak pressure and mucosal pressure in cm of water at insertion,after pneumoperitonium,at 30,60,90,120 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time required for insertion |
seconds |
| Number of insertion attempts |
1,2,3 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/04/2018 |
| Date of Study Completion (India) |
01/08/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Our study has been designed to compare Ambu®
AuraGainâ„¢ laryngeal mask airway with LMA ProSealâ„¢ in terms of which
would provide a high oropharyngeal leak pressure with less pharyngeal mucosal
pressure. LMA ProSealâ„¢ is a re-usable second generation SAD which forms
an effective “First Seal ™†with the oropharynx (oropharyngeal seal) and an
innovative “Second Sealâ„¢â€with the upper oesophageal sphincter (oesophageal
seal). Ambu® AuraGain™ is a new
second generation SAD, satisfying 3 fundamental airway management needs by
integrating gastric access and intubation capability in an anatomically curved
single use device that facilitates rapid establishment of a safe airway. Primary outcome is Oropharyngeal leak pressure and mucosal pressure. Secondary
outcomes are: Time
required for insertion, number
of insertion attempts ,ease of insertion, hemodynamic response
associated with insertion Size of the laryngeal mask airway is selected based
on the body weight of the patient. IV Fentanyl 2 microgram / kilogram of body
weight (kg BW) is given. After 2 minutes, induction with propofol 2 to 2.5mg
/kg BW IV is done. After check-ventilation, muscle relaxant vecuronium 0.1mg/kg
IV is administered. Patients are ventilated for 3 minutes with face mask till
adequate jaw relaxation is achieved. Before inserting the laryngeal mask
airway, irrespective of the group allocated, cuff of the laryngeal mask airway is
inflated with the maximum permissible air recommended by the manufacturer and the cuff pressure noted with a cuff
pressure manometer and is noted as Pex
vivo. The laryngeal mask airway is fully deflated and lubricated with a
water-soluble gel. After adequate depth of anesthesia and muscle relaxation is
achieved, the device ( LMA ProSeal
™or Ambu® AuraGain™) is inserted by an experienced anesthesiologist The
following parameters are recorded :
Time taken for
insertion
Number of insertion attempts
Ease of
insertion.
In vivo cuff pressure
Hemodynamic parameters: Heart rate and blood pressure
are recorded at 1 minute intervals during the insertion and until 5 minutes
after
Oropharyngeal leak
pressure is noted immediately after insertion of the laryngeal mask airway and after creation of pneumoperitoneum , at
15min intervals for 1 hour
|