CTRI Number |
CTRI/2020/02/023588 [Registered on: 26/02/2020] Trial Registered Retrospectively |
Last Modified On: |
26/02/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Comparison of three airway devices for general anaesthesia |
Scientific Title of Study
|
A Randomised Comparative Study of Three Supraglottic Airway Devices for Controlled Ventilation in Anaesthetised Paralysed Patients. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Bimla Sharma |
Designation |
Senior Consultant |
Affiliation |
Sir Ganga Ram Hospital,New Delhi |
Address |
5th floor, Department of Anaesthesiology, Sir Ganga Ram Hospital, New Delhi
New Delhi DELHI 110060 India |
Phone |
9810135366 |
Fax |
|
Email |
bimsharma@rediffmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Bimla Sharma |
Designation |
Senior Consultant |
Affiliation |
SIR GANGA RAM HOSPITAL, NEW DELHI |
Address |
Dr Bimla Sharma
Department Of Anaesthesiology, Sir Ganga Ram Hospital, Rajendra Nagar, New Delhi Dr Bimla Sharma
Department Of Anaesthesiology, Sir Ganga Ram Hospital, Rajendra Nagar, New Delhi New Delhi DELHI 110060 India |
Phone |
9810135366 |
Fax |
011-25861002 |
Email |
bimsharma@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Manoj Sharma |
Designation |
PG student |
Affiliation |
Sir Ganga Ram Hospital,New Delhi |
Address |
5th floor, Department of Anaesthesiology, Sir Ganga Ram Hospital, New Delhi
New Delhi DELHI 110060 India |
Phone |
7011160626 |
Fax |
|
Email |
dr.manoj880@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesia, SIR GANGA RAM HOSPITAL, OLD RAJENDRA NAGAR, NEW DELHI-110060 |
|
Primary Sponsor
|
Name |
Sir Ganga Ram Hospital |
Address |
Sir Ganga Ram Hospital, old rajender Nagar, New Delhi |
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 |
Dr Bimla Sharma |
Sir Ganga Ram Hospital |
Department of Anaesthesia, 5th floor, Sir Ganga Ram Hospital, old rajender nagar, New Delhi-110060 Central DELHI |
9810135366
bimsharma@rediffmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics committee Sir Ganga Ram Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
surgical patients, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Ambu Aura Gain |
The Ambu Aura Gain™ is Ambu’s 2nd generation laryngeal mask that integrates gastric access and intubation capability. It is an anatomically curved single-use device that facilitates rapid establishment of a safe airway. It has a wider airway tube than the LMA Supreme™ and the ProSeal LMA™ which allows the passage of a larger tracheal tube through it. It is made up of polyvinyl chloride (PVC), which is phthalate-free.
It may be used where unexpected difficulties arise in connection with airway management. It is intended for use as a conduit for an endotracheal tube in cannot intubate ,cannot ventilate situations and when it is necessary to place a tracheal tube after insertion of supraglottic device.It has navigation marks for guiding flexible scope and can be safely used during Magnetic Resonance Imaging (MRI).
The Ambu Aura Gainâ„¢ combines the best features of previous LMAs to provide superior safety and ease of use. The integrated drain tube is designed to channel fluid and gas safely away from the airway.
The present study will compare these three devices undergoing elective surgery in paralysed patients up to 2 hours of duration with respect to oropharyngeal seal pressure, fibreoptic confirmation of anatomical position, ease of insertion, first attempt insertion success rate, no of attempts to insert gastric tube and pharyngolaryngeal morbidity.
|
Intervention |
LMA ProSeal |
The ProSeal laryngeal mask airwayâ„¢ (PLMA) is an extensively used device and is a prototype of 2nd generation LMAs. It is a directional perilaryngeal sealer. It has a unique cuff and double tube design and allows an oropharyngeal seal pressure of up to 30 cm H2O. It enables positive pressure ventilation (PPV) at higher peak airway pressure (PAP) as compared to the classic LMA.4
When the ProSeal LMAâ„¢ is properly placed, its drain tube separates the alimentary and respiratory tracts, detects malposition and provides protection against aspiration in fasted patients as supported by design, clinical, laboratory, and cadaveric evidence.
The ProSeal LMAâ„¢ has the possible disadvantage of transmitting infection on subsequent use as it is meant for multiple uses. The other problem with this device is that malposition can occur as the device can get folded on itself, especially on repeat use. Since it has a narrow airway tube, it allows the passage of a relatively smaller tracheal tube. This has led to the introduction of newer devices which can overcome these shortcomings.
|
Intervention |
LMA Supreme |
The LMA Supremeâ„¢ was introduced in late 2007 by Archie Brain. It is a single use device made from PVC. It is an anatomically curved LMA that facilitates its easy insertion 5. It generates high OSP and has a larger cuff volume than the ProSeal LMAâ„¢. Different studies have reported varying OSPs compared to the ProSeal LMAâ„¢. The LMA Supremeâ„¢ has a built in bite block and fixation tab to secure the airway. An oval airway cross section is present for improved stability of the airway, in comparison to ProSeal LMAâ„¢ which has circular cross section. |
Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1) Age 18 years or more
2) ASA physical status 1 to3
3) Fasting more than 6 hours |
|
ExclusionCriteria |
Details |
1) patients who have not fasted
2) patients with anticipated difficult airway
3) patients with inadequate mouth opening to permit insertion of device
4) patients for emergency surgery
5) Patients who are prone to aspiration
6) patients with BMI more than 40 kg/m2
7) patients requiring tracheal intubation. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Oropharyngeal seal pressure (OSP) |
From induction to 5 minutes after induction |
|
Secondary Outcome
|
Outcome |
TimePoints |
1) Fiberoptic confirmation of anatomical position
2) Ease of insertion
3) First attempt insertion success rate (%)
4) Number of attempts for insertion of gastric tube
5) Pharyngolaryngeal morbidity
Sore throat/dysphonia/dysphagia
6) Other adverse events |
From induction to 2hrs post operatively |
|
Target Sample Size
|
Total Sample Size="270" Sample Size from India="270"
Final Enrollment numbers achieved (Total)= "270"
Final Enrollment numbers achieved (India)="270" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/03/2015 |
Date of Study Completion (India) |
31/10/2016 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="6" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
This study have not been published anywhere till date |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Supraglottic airway devices (SAD) have revolutionised the field of airway management. These devices are above the glottis or the larynx and are also known as extraglottic devices. The first such device, the classic laryngeal mask airway (cLMA) was invented by Dr Archie Brain and introduced into clinical practise in 1988. It was followed by the introduction of several supraglottic devices in later years. ProSeal LMA, LMA Supreme, Ambu laryngeal mask, i-gel, Laryngeal Tube Suction (LTS), the intubating LMA (ILMA), oesophageo-tracheal combitube and cobra perilaryngel airway are a few of the popular supraglottic devices in use. Ambu Aura Gain is a new such device introduced in 2014. These airway devices form a niche between a facemask and a tracheal tube.The last 30 years have witnessed increasing use and the widening scope of the SADs right from prehospital care,remote locations to operation theatres and cardiopulmonary resuscitation.This popularity stems directly from their ease of use,simplicity of training,predictability and speed of insertion. Supraglottic airway devices have been classified in many ways depending on;a)whether they are reusable or disposable b)sealing mechanism c) ability to protect against aspiration d) direct endotracheal intubation facilitation.White et al described the first generation supraglottic device as a simple airway tube.The second generation device has a larger cuff with dorsal and ventral components to provide a higher oropharyngeal seal pressure (OSP) than earlier options and a drain tube for gastric decompression,which may significantly decrease the risk of pulmonary aspiration during the course of anaesthesia. Miller developed a classification for supraglottic airways based on sealing mechanism. They can be cuffed perilaryngeal sealers, cuffed pharyngeal sealers and cuffless anatomically preshaped sealers. They can also be classified depending on the feasibility of straight forward intubation through them. The latter have also been labelled as third generation SADs. The most recently introduced Ambu Aura Gain is a single use, disposable, cuffed perilaryngeal sealer. It is made up of polyvinyl chloride (PVC) which is phthalate free. The phthalates are known to alter the endocrine system, interfere with steroid genesis and interfere with luteal function in females. Phthalates also act as anti androgenic. The Ambu Aura Gain also facilitates insertion of large size tracheal tube as the airway tube is wider and there are no epiglottic bars. In this study, we are comparing ProSeal LMA, Ambu Aura Gain and LMA Supreme, all of which provide higher OSP than the cLMA or an Ambu mask. In addition to the airway tube, a drain tube is also present for gastric access in all of the three above stated LMa variants. |