CTRI Number |
CTRI/2019/01/016929 [Registered on: 04/01/2019] Trial Registered Retrospectively |
Last Modified On: |
03/01/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Prospective comparative study |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of two upper airway devices with endotracheal tube in individuals undergoing laparoscopic surgeries |
Scientific Title of Study
|
A comparative study to evaluate the efficacy of i-gel, proseal laryngeal mask airway and endotracheal tube in individuals 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 |
Pranshi Jain |
Designation |
Primary DNB Anaesthesiology |
Affiliation |
Bhagat Phool Singh Government Medical College For Women |
Address |
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonipat Haryana Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonipat Haryana Sonipat HARYANA 131305 India |
Phone |
7056090969 |
Fax |
|
Email |
jainpranshi25@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Meenu Agrawal |
Designation |
Associate Professor Department Of Anaesthesiology |
Affiliation |
Bhagat Phool Singh Government Medical College For Women |
Address |
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonipat Haryana Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonipat Haryana Sonipat HARYANA 131305 India |
Phone |
8059286591 |
Fax |
|
Email |
meenu297@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Pranshi Jain |
Designation |
Primary DNB Anaesthesiology |
Affiliation |
Bhagat Phool Singh Government Medical College For Women |
Address |
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonipat Haryana Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonipat Haryana Sonipat HARYANA 131305 India |
Phone |
7056090969 |
Fax |
|
Email |
jainpranshi25@gmail.com |
|
Source of Monetary or Material Support
|
Bhagat Phool Singh Government Medical College For Women |
|
Primary Sponsor
|
Name |
Bhagat Phool Singh Government Medical College For Women |
Address |
Khanpur Kalan Sonipat Haryana 131305 |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
Name |
Address |
Not Applicable |
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Pranshi Jain |
Bhagat Phool Singh Government Medical College For Women |
Operation Theatre Complex Department Of Anaesthesiology Sonipat HARYANA |
7056090969
jainpranshi25@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 |
, , |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
A Comparative study to evaluate the efficacy of I-gel, Proseal Laryngeal Mask Airway and Endotracheal tube in individuals undergoing laparoscopic surgeries. |
All adult patients undergoing laparoscopic procedures under general anaesthesia using controlled ventilation will be selected. Published data from previous similar studies were used to determine the sample size. In Group-A (I-gel) appropriate sized I-gel will be inserted, and in Group-B (endotracheal tube) patient airway will be secured with laryngoscopy - guided endotracheal intubation and Group-C (Proseal Laryngeal Mask Airway) appropriate sized Proseal Laryngeal mask airway (LMA)will be inserted. Patient selection will be based on certain inclusion and exclusion criteria. |
Intervention |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Patients who have the ability to give informed consent (i) Age: 18-65 years (ii) ASA I–II (iii) elective surgery (iv) fasting for at least 8 hours. |
|
ExclusionCriteria |
Details |
Patients with ASA physical Status III or IV, anticipated difficult airway, mouth opening <2.5 cm, cervical spine disease ,obesity (body mass index > 35 kg/m 2 ), oropharyngeal pathology, emergency cases, cardiopulmonary disease, cervical spine fracture or instability, or at increased risk of aspiration (gastro-esophageal reflux disease, hiatus hernia, full stomach and heartburn), pregnant patients, reported history of any pathology of the neck or airway, history of lung diseases or oesophageal reflux will be excluded. |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To determine the efficacy ease and insertion characteristics of supraglottic airway devices & endotracheal tube |
120 min |
|
Secondary Outcome
|
Outcome |
TimePoints |
To determine the hemodynamic changes and ventilation parameters and intraoperative and postoperative laryngo-pharyngeal morbidity and sealing pressure |
24 hours |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/12/2016 |
Date of Study Completion (India) |
31/12/2018 |
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)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Not Applicable |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Till date, tracheal intubation
is considered to be the gold standard for providing seal in laparoscopic
surgeries but over a period of time supraglottic airway devices ( like I-gel and Proseal Laryngeal Mask Airway) have
evolved which overcome the disadvantages of endotracheal tube.A comparison of
I-gel, Proseal Laryngeal Mask Airway and Endotracheal Tube in laparoscopic
surgeries by Rukhsana Najeeb et al in 2015 shows that I-gel was easier to
insert with higher success rate in first attempt (92.5%) than Proseal Laryngeal
Mask Airway (85%) and endotracheal tube (82.5%).(3) Till
date, there are limited studies which have evaluated and compared I-gel,
Proseal Laryngeal Mask Airway and Endotracheal tube together for features like leak
volume, leak fraction and leak pressure. We
will conduct this study to compare supraglottic airway devices like I-gelTM
and Proseal Laryngeal Mask Airway with standard endotracheal tube for the
parameters that include number of attempts taken for insertion, hemodynamic
changes, ventilation parameters, leak volume, leak fraction, leak pressure and
postoperative complications during general anaesthesia, in healthy adult
patients undergoing laparoscopic surgeries. First 90 patients meeting the inclusion criteria will be enrolled in the
study. Group E (n=30) receiving
endotracheal tube, Group P (n=30) receiving Proseal Laryngeal Mask Airway and
Group I (n=30) receiving I-gel for airway maintenance. Patients will be
assessed for insertion characteristics of airway devices (insertion at first
attempt with no resistance; insertion at second attempt; insertion at third
attempt and failed insertion - insertion not possible), hemodynamic responses
(heart rate and blood pressure), ventilation parameters, leak pressure, leak
volume, intraoperative and postoperative complications. Statistically significant
(p<0.05) increase in heart rate and the mean blood pressure will be observed
immediately after insertion, persisted till 5 minutes after intubation and
during the time of extubation. We will observe incidence of blood staining of
the device, sore throat and dysphasia,
coughing, laryngospasm, gastric insufflation, regurgitation, aspiration, billous secretion, stridor, hoarseness of voice, injuries (to lip, teeth, and gum), and dysphonia during perioperative
period. |