| CTRI Number |
CTRI/2021/08/035533 [Registered on: 09/08/2021] Trial Registered Prospectively |
| Last Modified On: |
06/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of two supraglottic airway devices in adult patients undergoing elective surgery under general anaesthesia. |
|
Scientific Title of Study
|
Comparative evaluation of two second generation supraglottic airway devices 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 |
Prashant Kumar |
| 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 |
9873750861 |
| Fax |
|
| Email |
prashantkumar546@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Agrawal |
| Designation |
Professor |
| 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 |
Prashant Kumar |
| Designation |
PG Student |
| 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 |
9873750861 |
| Fax |
|
| Email |
prashantkumar546@gmail.com |
|
|
Source of Monetary or Material Support
|
| Safdarjung hospital and Vardhman Mahavir Medical College . New Delhi, India |
|
|
Primary Sponsor
|
| Name |
Safdarjung hospital and Vardhman Mahavir Medical College New Delhi India |
| Address |
Department of Anaesthesia and intensive care Ground floor, main operation theatre building. Safdarjung hospital and Vardhman Mahavir Medical College New Delhi 110029, India |
| 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 |
| Prashant Kumar |
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
New Delhi
DELHI |
9873750861
prashantkumar546@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
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
i-gel |
i-gel of appropriate size will be inserted with the patient’s head in sniffing position. The lubricated i-gel will be grasped firmly along the integral bite block. The device will be positioned so that the i-gel cuff outlet is facing towards the chin of the patient. The chin will be gently pressed down before proceeding to insert the i-gel. The leading soft tip will be inserted into the mouth of the patient in a direction towards the hard palate. The device will be glided downwards and backwards along the hard palate with a continuous but gentle push until a definitive resistance is felt. At this point the incisors should be resting on the integral bite-block .i-gel has a non-inflatable cuff and does not need inflation. |
| 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 patient’s head and neck will be placed in sniffing position. The mouth will be opened with the investigator’s 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 the hypopharynx in one smooth circular movement pressing against the contours of the hard and the soft palate, until definite resistance is felt. Cuff of LMA Protector will be inflated with air to 60 cm of water using cuff pressure gauge . Intracuff pressure will be checked every 30 minutes and adjusted to 60 cm 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 |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA physical status grade 1 and 2 undergoing elective surgery under general anaesthesia with controlled ventilation in supine position |
|
| ExclusionCriteria |
| Details |
1)Patients with anticipated difficult airway including:
Thyromental distance <6.5 cm,
Upper lip bite test class >1,
Mallampatti class III and IV,
Restricted head and neck mobility,
Mouth opening <3.5 cm, BMI>30 kg/m2
2) Cervical spine pathology
3) Intestinal and oesophageal pathology
4) Operation time greater than 4 hours
5) High risk of aspiration
6) Preoperative sore throat
7) Poor dentition with high risk of damage
8) 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 |
1. within 5 minutes after device insertion
2. At 30 minutes 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)
|
15/08/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective randomised study has been designed to evaluate and compare the clinical efficacy of LMA Protector with i-gel as a ventilatory device in adult patients undergoing elective surgery under general anesthesia with controlled ventilation. We hypothesise that Laryngeal Mask Airway Protector will have a better clinical efficacy as a ventilatory device as compared to i-gel in terms of higher oropharyngeal leak pressure in adult patients undergoing elective surgery under general anaesthesia with controlled ventilation. This study will be conducted in 100 adult patients of either gender, in age group of 18 to 60 years, weighing 30- 70 Kg, American society of Anaesthesiologists (ASA) physical status I and II undergoing elective surgery under general anaesthesia with controlled ventilation in supine position.
Patients will be randomly allocated to two groups of 50 each. Group I- i- gel will be inserted in the patients (n= 50) Group P- LMA Protector will be inserted in the patients(n= 50) Computer generated random number table will be used to allocate patients to two groups. Allocation will be concealed in sequentially numbered sealed opaque envelopes. Once a patient gives consent to enter the study, an envelope will be opened and the patient will then be offered the allocated group.
Preanaesthetic evaluation of the patient will be done ,those falling under exclusion criteria will be excluded, written informed consent will be taken from the patient Patient will be taken to operation theatre . Baseline vitals noted preoxygenation for 3 minutes with 100% oxygen Induction with Fentanyl 2 μ/kg, Propofol 2-2.5mg/kg followed by vecuronium 0.1mg/kg Face mask ventilation with Isoflurane (1-1.5%) in 50 % oxygen and 50% nitrous oxide for 3 minutes Group P- LMA - Protector inserted n=50 Group I- i- gel inserted n=50
Confirmation of achieving effective ventilation and correct gastric catheter insertion Parameters to be noted 1.Oropharyngeal seal pressure 2 .Insertion characteristics-Number of attempts taken for successful insertion of device, time for achieving effective ventilation, ease of insertion of device, ease of gastric catheter insertion 3.Anatomical alignment of device to glottic opening
Postoperative pharyngolaryngeal morbidity noted
Primary objective is to compare Laryngeal Mask Airway Protector with i-gel in terms of oropharyngeal leak pressure in adult patients undergoing elective surgery under general anaesthesia with controlled ventilation. SECONDARY OBJECTIVES: To compare following insertion characteristics of Laryngeal Mask Airway Protector with i-gel in adult patients undergoing elective surgery under general anaesthesia with controlled ventilation: -Number of attempts taken for successful insertion of device, -Time for achieving effective ventilation, -Ease of insertion of device, -Ease of gastric catheter insertion -Fibreoptic bronchoscopic score regarding anatomical alignment of device |