CTRI Number |
CTRI/2020/07/026406 [Registered on: 07/07/2020] Trial Registered Prospectively |
Last Modified On: |
03/07/2020 |
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 two supraglottic airways in key hole surgeries |
Scientific Title of Study
|
Comparison of AIR-Q LMA with Baska Mask in patients undergoing laparoscopic surgeries under general anaesthesia with positive pressure ventilation. A randomized control study. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Preethi P |
Designation |
MD ANAESTHESIA POST GRADUATE STUDENT |
Affiliation |
S N MEDICAL COLLEGE |
Address |
Dr PREETHI P
1ST YEAR MD ANAESTHESIA STUDENT
S N MEDICAL COLLEGE
BAGALKOT--587102
Bagalkot KARNATAKA 587102 India |
Phone |
9652101885 |
Fax |
|
Email |
preethipalampalli@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ramesh Koppal |
Designation |
Professor |
Affiliation |
S N Medical college, bagalkot |
Address |
Dept of anaesthesia
S N MEDICAL COLLEGE
Navanagar
BAGALKOT b 24, S N Medical college staff quarters, navanagar,
Bagalkot Bagalkot KARNATAKA 587102 India |
Phone |
9845504515 |
Fax |
|
Email |
rameshkoppaldr@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Preethi P |
Designation |
MD ANAESTHESIA POST GRADUATE STUDENT |
Affiliation |
S N MEDICAL COLLEGE |
Address |
Dr PREETHI P
1ST YEAR MD ANAESTHESIA STUDENT
S N MEDICAL COLLEGE
BAGALKOT--587102
KARNATAKA 587102 India |
Phone |
9652101885 |
Fax |
|
Email |
preethipalampalli@gmail.com |
|
Source of Monetary or Material Support
|
S N Medical college and H S K Hospital Bagalkot |
|
Primary Sponsor
|
Name |
S NIJALINGAPPA MEDICAL COLLEGE AND HSK HOSPITAL |
Address |
S NIJALINGAPPA MEDICAL COLLEGE AND HSK HOSPITAL, BAGALKOT 587102 |
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 |
Preethi Palampalli |
SN Medical college and HSK Hospital Bagalkot |
1st floor, Major OT complex,IPD block Bagalkot KARNATAKA |
9652101885
preethipalampalli@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SNMC-INSTITUTIONAL EHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
AIR Q and Baska mask |
Securing airway with LMA in Laparoscopic surgeries |
Intervention |
Laryngeal mask airway |
Ease of insertion, Oropharyngeal seal pressure |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
ASA 1 & 2
Patients undergoing laparoscopic surgeries.
BMI- <30 |
|
ExclusionCriteria |
Details |
patient refusal to give consent
anticipated difficult airway
patients who are prone for gastric aspiration
patients with neck pathologies
pregnancy |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Ease of insertion and oropharyngeal leak pressure in elective laparoscopic surgeries. |
24hrs after insertion of LMA |
|
Secondary Outcome
|
Outcome |
TimePoints |
Assessing the post extubation sore throat, airway bleeding. |
24hrs after insertion of LMA |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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
|
N/A |
Date of First Enrollment (India)
|
11/07/2020 |
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
|
Damodaran S et al,[1] conducted a prospective randomized controlled trial among 75 patients aged between 18-60 years, divided into 3 equal groups to compare OLP, ease of device insertion, time for placement of device, number of attempts to insert device and ease of gastric tube insertion in Air-Q, i-gel and LMA-S. Time taken for Air-Q insertion was higher than time taken for i-gel and LMA-S. It was concluded that all three were equally efficacious in terms of routine airway management. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Advantages of using supraglottic airway devices for airway management include avoidance of laryngoscopy, increased ease of placement, better hemodynamic stability, to provide clear airway a quicker manner and are designed to overcome the disadvantages of endotracheal intubation like soft tissue injury, exaggerated haemodynamic response. Newer SGA(supraglottic airway device) devices have also overcome the limitations of first generation SGA devices which has lower orpharangeal leak pressure and also reduces the complications of laryngospasm, cough on removal, hoarseness of voice and sore throat which are higher in endotracheal intubation. AIR Q is a second generation supraglottic airway device that has better cuff, it has removable connector ,large inlet, anatomical bowl and built (mask heel improve placement and seal),epiglottis elevator( which will opens the airway to maximise the access),it has guide ramp( helps to direct the scopes & tube placement, it has a safety hole which provides gas exchange if main tube becomes occluded . Air Q can be a conduit for tracheal intubation. The Baska Mask is a third generation supraglottic airway device with a non inflatable preformed cuff, an oesophageal drainage inlet, and side channels to facilitate aspiration of gastric contents, and an integrated bite block. Many studies have established utility and advantages of AIR Qand Baska mask independently in laparoscopic surgeries. Currently there are no studies in english literature which compare AIR Qand Baska mask in adult patients undergoing laparoscopic surgery. In this study we are comparing the oropharyngeal leak pressure, ease of insertion and complications between AIR Qand Baska mask in adult patients undergoing laparoscopic surgery so as to find out better SGA amongst these two. |