CTRI Number |
CTRI/2022/12/047909 [Registered on: 06/12/2022] Trial Registered Prospectively |
Last Modified On: |
18/11/2022 |
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 two airway devices in adult patients undergoing elective surgery under general anaesthesia |
Scientific Title of Study
|
Comparative evaluation of efficacy of two anatomically preformed supraglottic airway devices for ventilation in adult patients undergoing elective surgery under general anaesthesia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR ASWATHI S ANAND |
Designation |
POST GRADUATE RESIDENT (Anaesthesia) |
Affiliation |
Safdarjung Hospital and Vardhman Mahavir Medical College |
Address |
Department of Anaesthesia and Intensive Care. Ground floor, Main operation theatre building, Safdarjung hospital and Vardhman Mahavir Medical college, New Delhi, 110029
New Delhi DELHI 110029 India |
Phone |
8590449334 |
Fax |
|
Email |
aswathianjanam@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
DR NIDHI AGRAWAL |
Designation |
CONSULTANT |
Affiliation |
Safdarjung Hospital and Vardhman Mahavir Medical College |
Address |
Department of Anaesthesia and Intensive Care. Ground floor, Main operation theatre building, Safdarjung hospital and Vardhman Mahavir Medical college, New Delhi, 110029
New Delhi DELHI 110029 India |
Phone |
9811030408 |
Fax |
|
Email |
nidhi.agrawal1970@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR NIDHI AGRAWAL |
Designation |
CONSULTANT |
Affiliation |
Safdarjung Hospital and Vardhman Mahavir Medical College |
Address |
Department of Anaesthesia and Intensive Care. Ground floor, Main operation theatre building, Safdarjung hospital and Vardhman Mahavir Medical college, New Delhi, 110029
New Delhi DELHI 110029 India |
Phone |
9811030408 |
Fax |
|
Email |
nidhi.agrawal1970@gmail.com |
|
Source of Monetary or Material Support
|
Safdarjung Hospital and Vardhman Mahavir Medical college, New Delhi,India |
|
Primary Sponsor
|
Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Address |
Department of Anaesthesia and intensive care. Ground floor, main operation theatre building, Safdarjung hospital and Vardhman Mahavir Medical college, New Delhi, 110029
|
Type of Sponsor |
Government 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 ASWATHI S ANAND |
Safdarjung hospital and Vardhman Mahavir Medical College |
Department of Anaesthesia and intensive care. Ground floor, main operation theatre building, Safdarjung hospital and Vardhman Mahavir Medical college, New Delhi, 110029 New Delhi DELHI |
08590449334
aswathianjanam@yahoo.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
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Ambu AuraGain |
Ambu AuraGain of appropriate size will be inserted as per manufacturers instructions. Before insertion cuff will be deflated completely and a sterile, water based lubricant will be applied to the posterior surface of the cuff. The airway tube will be held like a flute, with three fingers placed on the flat part of the bite absorption area and the thumb on the vertical line on the bite absorption area, which is oriented anteriorly towards the patients nose. The other hand will be placed under the patients head. The tip of the cuff will be inserted by pressing upward against the hard palate thus the flattening the cuff against it. The jaw will be gently pushed downwards with the middle finger to open the mouth further. The tip of the cuff will be placed correctly in the mouth opening and inserted by swinging the mask inward with a continuous circular motion, pressing the contours of the hard and soft palate. The Ambu AuraGain will be advanced into the hypopharynx until a definite resistance is felt, where its tip will be resting against the upper oesophageal sphincter. |
Intervention |
LMA Protector |
LMA Protector of appropriate size will be introduced. Cuff of the device will be fully deflated and posterior surface of the mask and airway tube will be lubricated with water soluble lubricating jelly, the patients head and neck will be placed in sniffing position . The mouth will be opened with the investigators nondominant hand. Using the dominant hand, device will be introduced in the oral cavity pressing the posterior part of the tip of the mask against the hard palate . Device will be advanced further into hypopharynx in one smooth circular movement pressing against the contours of the hard and the soft palate until definite resistance is felt. Device will be fixed to the cheeks with tape placed transversely across fixation tab. Cuff of LMA protector will be inflated with air to 60cm of water using cuff pressure gauge. Intracuff pressure will be checked every 30 minutes and adjusted to 60cm of water throughout anaesthesia. the LMA Protector cuff pilot technology will be compared to the cuff pressure measured by a manometer. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
This study will be conducted in adult patients , in age group 18 to 65 years, weighing 30 to 70 kg, ASA physical status I and II undergoing elective surgery under general anaesthesia with controlled ventilation in supine position. |
|
ExclusionCriteria |
Details |
1)Patients with anticipated difficult airway
2)Mouth opening less than 3.5cm, BMI more than 30kg/m2
3)Cervical spine pathology
4)Intestinal and oesophageal pathology
5)Operation time greater than 4 hours
6)High risk of aspiration
7)Cardiac and pulmonary compromise, Hypertension
8)Poor dentition with high risk of damage
9)Pregnancy |
|
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 |
after device insertion |
|
Secondary Outcome
|
Outcome |
TimePoints |
Number of attempts taken for successful insertion of device, Time for achieving effective ventilation, Number of patients requiring manipulation for achieving effective ventilation and type of manipulation, Ease of insertion of device, Ease of gastric catheter insertion, Score regarding anatomical alignment of device |
At the time of device insertion. |
|
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)
|
12/12/2022 |
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 Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
The supraglottic airway device is commonly used for airway management during anaesthesia or as an immediate life saving measurement in patients with difficult or failed airway. The laryngeal mask protector(LMA Protector) is a new second generation supraglottic airway device made with medical grade silicon. The LMA protector provides access tp and functional separation of the ventilation and digestive tract, with the presence of two drainage channels, which emerge proximally as separate ports and enter the chamber located behind th cuff bowl. Ambu AuraGain is a well established second generation supraglottic airway device. It has noninflatable gel like cuff made up of medical grade thermoplastic elastomer and designed to anatomically fit the peri laryngeal structures to provide effective seal. This study will compare LMA Protector and Ambu AuraGain, mainly on the basis of the oropharyngeal leak pressure, also compares other parameters during the insertion of these devices. |