| CTRI Number |
CTRI/2024/09/073673 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two different airways in Patients undergoing General Anaesthesia |
|
Scientific Title of Study
|
Comparison of Laryngeal Mask Airway Protector versus Laryngeal Mask Airway Blockbuster in Patients undergoing General Anaesthesia: A Randomised Control Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankur Garg |
| Designation |
Associate Professor |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room No 2602-F, Department of Anaesthesiology, Rohilkhand Medical College and Hospital,4,
Pilibhit bypass road, Pawan Vihar, Bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
9650715363 |
| Fax |
|
| Email |
ankurgarg.gsvm@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ankur Garg |
| Designation |
Associate Professor |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room No 2602-F, Department of Anaesthesiology, Rohilkhand Medical College and Hospital,4,
Pilibhit bypass road, Pawan Vihar, Bareilly
UTTAR PRADESH 243006 India |
| Phone |
9650715363 |
| Fax |
|
| Email |
ankurgarg.gsvm@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prajwalit Bhanu |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical college and hospital |
| Address |
Room No 2602-F, Department of Anaesthesiology, Rohilkhand Medical College and Hospital,4,
Pilibhit bypass road, Pawan Vihar, Bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
9096426996 |
| Fax |
|
| Email |
Bhanuprajwalit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College And Hospital, 4, Pilibhit bypass road, Bareilly, Uttar Pradesh, India,
Pincode: 243006 |
|
|
Primary Sponsor
|
| Name |
Rohilkhand Medical College and Hospital |
| Address |
Rohilkhand Medical College And Hospital, 4, Pilibhit bypass road, Bareilly, Uttar Pradesh, India,
Pincode: 243006 |
| Type of Sponsor |
Private 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 Ankur Garg |
Rohilkhand Medical College and Hospital |
Room No 2602-F, Department of Anaesthesiology, Rohilkhand Medical College and Hospital, 4, Pilibhit Bypass Road, Bareilly,Uttar Pradesh, Pincode: 243006 Bareilly UTTAR PRADESH |
9650715363
ankurgarg.gsvm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RMCH, Bareilly |
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 |
LMA BLOCKBUSTER |
A revolutionary second generation LMA(Laryngeal Mask Airway) known as LMA Blockbuster. LMA BlockBuster incorporates features that address some of the limitations observed in earlier LMA designs. Its peculiarities, such as enhanced seal pressure capabilities and improved ease of insertion, contributed to its growing popularity. The LMA BlockBusters design focuses on providing a high degree of airway security and ventilation efficiency. |
| Intervention |
LMA PROTECTOR |
After the device ( LMA PROTECTOR) is properly inserted,presence of an effective airway is verified.
Correct Positioning will be confirmed.The oropharyngeal seal pressure will be measured and the number of attempts of LMA insertion will be recorded.
Evaluation of the Ease of insertion of SGA devices will be done .
The effective device insertion time will be measured in seconds, beginning with the operator picking up the device and ending with the square wave of the capnograph trace.
Hemodynamic parameters will be measured before LMA insertion, At the time of LMA Insertion, every 5 minutes after LMA insertion till 60 minutes , then every 10 minutes and immediately after the removal of the device |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing elective surgeries under general anesthesia
2. Age between 18 to 60 years
3. ASA physical status of I or II
4.Mallampati Classification (MMT) of I & II
5. BMI ≤ 30 kg/m²
|
|
| ExclusionCriteria |
| Details |
1. Morbid Obesity, Pregnancy.
2. Patient with neck pathology
3. Anticipated difficult airway
4. Pre-existing cervical spine disease
5. History of gastro-oesophageal reflux or increased risk of Gastric aspiration.
6. Lesion in oral cavity
7. Loose denture
8. Head & Neck surgeries
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Time taken for insertion of Supraglottic Airway Devices.
2.Total number of attempts
3.Ease of Insertion
4.Oropharyngeal seal pressure
5.Blood stain on the device
6.Sore throat
7.Airway trauma
|
Before LMA insertion, At the time of LMA Insertion, every 5 minutes after LMA insertion till 60 minutes , then every 10 minutes and immediately after the removal of the device. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters like Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP), Mean Arterial Pressure(MAP), Heart Rate(HR), SpOâ‚‚ |
Before LMA insertion, At the time of LMA Insertion, every 5 minutes after LMA insertion till 60 minutes , then every 10 minutes and immediately after the removal of the device. |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/09/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Bhanuprajwalit@gmail.com].
- For how long will this data be available start date provided 11-08-2024 and end date provided 03-09-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Securing airway is of critical importance in patients undergoing surgeries and its maintenance is essential for stability of the patient during surgery. The airway management serves as the foundation on which efficacy and safety of anesthesia practice are built. Laryngeal Mask Airway (LMA) is an important tool used for maintenance of airway. Such devices revolutionized the practice which were introduced by Archie Brain and it was less stressful than tracheal intubation to the patients. It was as safe as using a facemask and airway. These are commonly employed in anaesthetic, critical care, and emergency scenarios for managing the airway. It also excels in managing challenging airways. It offers advantage of avoiding endotracheal intubation and provides a shorter insertion time as well as it has lower incidence of post-operative pharyngeal pain, and better hemodynamic stability during induction and emergence. The mechanism of action of LMAs is through the creation of a low-pressure seal around the laryngeal inlet which permits positive pressure ventilation. This design minimizes the need for neuromuscular blockade and allows for a smoother airway management process, particularly in cases where intubation may be challenging or unnecessary. Over the years, various LMA devices have been developed. Each with specific features are designed to improve its ease of use, safety, and effectiveness. These range from the classic LMA, flexible LMA, to more recent LMAs such as the LMA Supreme, LMA ProSeal, LMA protector and last but not the least LMA Blockbuster. Among these, One notable device in this group is the LMA Protector, which stands out due to its advanced features that aim to improve patient safety and make it easier to insert. The LMA Protector, with its dual gastric access channels and cuff pressure monitoring capabilities, represents a significant advancement in LMA technology. The device is designed to offer superior protection against aspiration, a critical consideration in anesthesia management. However, despite its advantages, the LMA Protector is not without challenges. Issues such as the need for precise placement, potential for increased costs, and the requirement for training to optimize its use are notable concerns. A revolutionary second generation LMA known as the Blockbuster LMA developed by Prof. Ming Tian in 2012. The LMA BlockBuster represents another significant advancement in airway management technology. The LMA BlockBuster incorporates features that address some of the limitations observed in earlier LMA designs. Its peculiarities, such as enhanced seal pressure capabilities and improved ease of insertion, contributed to its growing popularity. The LMA BlockBuster’s design focuses on providing a high degree of airway security and ventilation efficiency. Comparing the LMA Protector and LMA BlockBuster reveals significant differences that influence their use in anaesthesiology. The LMA Protector’s dual-channel design offers unique advantages in managing gastric contents and monitoring cuff pressure, potentially reducing the risk of aspiration. In contrast, the LMA BlockBuster, with its focus on ease of insertion and high seal pressures, may be preferred in scenarios where rapid and reliable airway management is critical. The choice between these devices often depends on specific patient conditions, surgical requirements, and the anaesthesiologist’s expertise and preference. Despite the advancements and the availability of various LMA devices, there remains a knowledge gap in the literature concerning the comparative effectiveness, safety, and applicability of the LMA Protector versus the LMA BlockBuster. Despite the extensive research being undertaken on the topic of various LMAs, the comparison between LMA Protector and LMA BlockBuster remains scarce. There is hardly any study that has come up with such comparison. There is a need for a comprehensive and well-designed comparative study addressing these two LMAs. With this background we undertook this study to compare the safety and efficacy between LMA Protector and LMA Blockbuster in providing airway management for patients undergoing surgeries under general anesthesia. |