| CTRI Number |
CTRI/2019/12/022336 [Registered on: 12/12/2019] Trial Registered Prospectively |
| Last Modified On: |
02/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This is a study in which we will compare how easily we can pass an endotracheal tube through two devices namely The I-Gel and The Blockbuster LMA respectively in patients who are undergoing operation under general anaesthesia. |
|
Scientific Title of Study
|
A comparative study to evaluate the ease of blind tracheal intubation through the I-gel versus the Blockbuster LMA during general anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aryan Guleria |
| Designation |
Junior Resident |
| Affiliation |
Dr.RPGMC Kangra at Tanda |
| Address |
Department of Anaesthesiology,
Dr.RPGMC Kangra at Tanda,
Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418495611 |
| Fax |
|
| Email |
drguleria79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jai Singh |
| Designation |
Professor |
| Affiliation |
Dr.RPGMC Kangra at Tanda |
| Address |
Department of Anaesthesiology,
Dr.RPGMC Kangra at Tanda,
Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418070893 |
| Fax |
|
| Email |
drjaisingh62@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aryan Guleria |
| Designation |
Junior Resident |
| Affiliation |
Dr.RPGMC Kangra at Tanda |
| Address |
Department of Anaesthesiology,
Dr.RPGMC Kangra at Tanda,
Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418495611 |
| Fax |
|
| Email |
drguleria79@gmail.com |
|
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Source of Monetary or Material Support
|
| Himachal Pradesh University |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Dr RPGMC Kangra at Tanda, H.P.
176001 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aryan Guleria |
Dr RPGMC Tanda |
Department of Anaesthesia
Kangra
HIMACHAL PRADESH |
9418495611
drguleria79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr RPGMC Institutional Ethics COmmittee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
The Blockbuster LMA |
The supraglottic airway device BlockbusterTM (Tuo Ren Medical Instrument Co., Ltd., Changyuan City, China) is a second generation supraglottic device. The device is pharyngeally inserted airway device with an anatomically shaped airway tube. It is designed to provide high airway seal pressures around the laryngeal opening and has a separate tract to insert a stomach tube to prevent gastric aspiration. This modified form of supraglottic airway device has been specially designed to facilitate blind tracheal intubation.
This device will be used for the entire duration of surgery feom the point of induction till the patient is extubated.
|
| Comparator Agent |
The I-Gel |
I-gel is the single use supraglottic airway from intersurgical, UK (Intersurgical Ltd, Wokingham, Berkshire, UK) with an anatomically designed mask made of gel like thermoplastic elastomer. It has feature designed to separate the gastrointestinal and respiratory tracts and allow a gastric tube to be passed in to the stomach. The tensile properties of the I-gel bowl, along with its shape and the ridge at its proximal end, contribute to the stability of the device upon insertion. Upon sliding beneath the pharyngo-epiglottic folds, it becomes narrower and longer, creating an outward force against the tissues. The ridge at the proximal bowl catches the base of the tongue, also keeping the device from moving out of the position.
This device will be used for the entire duration of surgery feom the point of induction till the patient is extubated. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patients will be ASA I or ASA II scheduled for laparoscopic surgery under general anaesthesia with BMI 18.5-29.9 and Mallampati III and IV. |
|
| ExclusionCriteria |
| Details |
The patients will be excluded from the study if they present as Mallampatti I or II, ASA III-V or emergency status or if they meet any one of the contradiction criteria including:
1. Obesity (BMI > 35kg/m2)
2. Pregnancy
3. History of gastric regurgitation, heart burn, ileus or "full stomach".
4. History of low pulmonary compliance or high pulmonary compliance.
5. Any Pharyngeal pathology.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome of this study is to compare the ease of the blind tracheal intubation among the two supraglottic airway devices : The Blockbuster LMA and the I-Gel and to look for various haemodynamic and airway parameter changes during the process while we successfully ventilate the patient.
To look for post intervention complications on device removal. |
The various time points in this study will start from the successful insertion of the Endotracheal tube through the Supraglottic airway device(SAD) into the patients airway till the point where the endotracheal tube is removed along with the SAD. The various haemodynamic and airway dynamic parameters will be noted every three minutes over the period of time of the surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Failure to intubate blindly through the Blockbuster LMA or the I-Gel. |
Every 30 seconds till airway is secured definitely. |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/12/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Airway management is the cornerstone of anaesthesia practice and the prime responsibility of the anaesthesiologist. Securing an adequate airway and ventilation is of utmost importance in patients undergoing surgeries under general anaesthesia. Tracheak intubation is the gold standard method for maintaining a patent airway during anaesthesia since the introduction of endotracheal tube by Mc Ewan. However this manoeuvre requires skill and continuous training. Suprraglottic airway devices are intrinsically more invasive than the use of a face mask for anaesthesia, but less invasive than the tracheal intubation. The I-Gel is a single use SAD. It does not have an inflatable cuff, made from a soft gel like and transparent thermoplastic elastomer(styrene ethylene butadiene styrene), it creates a non inflatable seal which is a mirror impression of the supraglottic anatomy. It has specific design features. I-Gel has also been usd as a conduit for tracheal intubation and in rescue airway management. The supraglottic airway device Blockbuster is a second generation supraglottic device. The device is pharyngeally inserted airway device with an anatomically shaped airway tube. This modified form of supraglottic airway device has been specially designed to fascilitate blind tracheal intubation. The aim of this study is to evaluate the ease of blind tracheal intubation through the I-Gel vs The Blockbuster LMA during general anaesthesia. |