| CTRI Number |
CTRI/2024/08/072151 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| 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 for patient undergoing general anaesthesia |
|
Scientific Title of Study
|
Comparison of Laryngeal mask airway Blockbuster and Laryngeal mask airway Supreme in patients undergoing General Anesthesia A Randomised Controlled Trial |
| 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 Richa Chandra |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room No 2062-D, Department of Anaesthesia, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
8279783945 |
| Fax |
|
| Email |
rinkichandra@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Richa Chandra |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room No 2062-D, Department of Anaesthesia, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
8279783945 |
| Fax |
|
| Email |
rinkichandra@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Indu Gupta |
| Designation |
Junior resident |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room No 2062-D, Department of Anaesthesia, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
9627152159 |
| Fax |
|
| Email |
guptaindu45627@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly |
|
|
Primary Sponsor
|
| Name |
Rohilkhand Medical College and Hospital |
| Address |
Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh 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 Richa Chandra |
Rohilkhand Medical College and hospital |
Room no 2062-D, department of anaesthesia Bareilly UTTAR PRADESH |
8279783945
rinkichandra@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,RMCH,Bareilly,U.P. |
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 |
| Intervention |
LMA Blockbuster |
The Blockbuster LMA is a multiple use device, well-tolerated airway conduit with tracheal intubation capabilities. It enhances the success rate of blind tracheal intubation. Constructed from flexible and biocompatible silicon material, the laryngeal mask includes an inflatable cuff and is connected to the airway tube at an angle exceeding 95 degree. |
| Comparator Agent |
LMA Supreme |
Supreme LMA is a single-use, latex-free device which is made of polyvinyl chloride with gastric access. The firm, elliptical, and anatomically shaped airway tube facilitates easy insertion. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Either sex.
BMI less than 26kg/m2
Mallampati classification I & II
ASA- I & II
Age- 18 to 65 years
Adequate head & movement
|
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway
Full stomach patients
Cervical spine instability
Temporomandibular joint pathology
History of gastro-oesophageal reflux or increased risk of Gastric aspiration
Pharyngeal & Laryngeal surgery
Thoracotomy
Lateral or prone surgery position
Pregnant females |
|
|
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. Number of attempts
2. Ease of insertion
3. Airway manipulation
4. Oropharyngeal seal Pressure 5. Post-operative Pharyngolaryngeal Morbidity
6. Ease and time of insertion of gastric tube
7. ETCO2 Graph (Capnography characteristics) |
Baseline, 5 minutes, 10 minutes, 15 minutes, postoperative time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters (Heart rate, systolic & diastolic blood pressure, mean arterial pressure) |
Baseline, 5 minutes, 10 minutes, 30 minutes & at the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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)
|
19/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/08/2024 |
| 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 - NO
|
|
Brief Summary
|
General anesthesia is described as a state of "Controlled Unconsciousnes allowing patients to undergo procedures that would be unbearable while awake. Ensuring a secure airway is crucial during general anesthesia to ensure proper ventilation, oxygenation, and administration of anesthetic gases.
The management of the airway is vital in both general anesthesia and resuscitation efforts. Endotracheal intubation, which requires a deeper level of anesthesia and greater expertise, is associated with a higher incidence of postoperative sore throat. In response to this challenge, a significant innovation emerged in 1981 with the introduction of the Laryngeal-mask airway by Dr. Archie Brain.
Supraglottic airway devices have become increasingly prevalent in airway management due to their advantageous anatomical placement and minimally invasive characteristics. These devices serve as a link between traditional face masks and tracheal tubes, positioned above the glottis, eliminating the need to enter the trachea. They provide a hands-free technique for securing the airway, enabling efficient ventilation, oxygenation, and administration of anesthetic gases without the requirement for tracheal intubation.
Supraglottic Airway (SGA) devices offer a more secure airway than a face mask and are less intrusive than tracheal intubation. They can be used for both spontaneous ventilation and Positive Pressure Ventilation. They also offer several advantages, such as rapid and uncomplicated placement, enhancement of hemodynamic stability, reduced anesthesia requirements, elimination of the need for muscle relaxation, and avoidance of certain risks associated with tracheal intubation. These risks include potential harm to teeth and airway structures, the occurrence of a sore throat, emergence-related coughing, and bronchospasm. Additionally, SGA devices offer an enhanced airway seal, achieved through improved seal materials or design, which simplifies intubation by allowing the use of regular endotracheal tubes and incorporates a gastric access port for venting and aspirating stomach contents.
The LMA BLOCKBUSTER, developed by Prof. Ming Tian, is part of the second generation of LMAs. It serves as a well-tolerated airway device with the capability for tracheal intubation. Featuring an intubation channel, it enhances the success rate of blind tracheal intubation while ensuring a secure seal and extended ventilation. Made from flexible and biocompatible silicone material, this laryngeal mask includes an inflatable cuff and is angled over 95 degrees for optimal placement. To ensure safety, a gastric tube can be inserted alongside to prevent gastric reflux and aspiration. It also includes features like an integrated bite block and sputum collection device. Additionally, it comes with an endotracheal tube featuring a Parker pen tip and an exchange guide.
LMA SUPREME is a single-use, latex-free laryngeal mask airway made of medical grade PVC. It combines features from various LMA designs. The device features an inflatable and large plastic cuff without a posterior cuff, an esophageal drain tube, and a pre-formed semi-rigid tube. Fins in the mask bowl help prevent epiglottic obstruction. Its pharyngeal seal is intermediate between cLMA and PLMA, while the oesophageal seal data is not available. The firm, elliptical, and anatomically shaped airway tube allows for easy insertion without requiring fingers in the patient’s mouth or an introducer tool.
Supraglottic airway devices (SADs) are frequently employed as alternatives to both face mask ventilation and tracheal intubation. However, there remains a lack of extensive research regarding the safety and efficacy of SADs like LMA Blockbuster and LMA Supreme. To bridge this knowledge gap, we are proposing a randomized controlled trial to compare the performance of LMA Blockbuster and LMA Supreme in patients undergoing general anesthesia. |