| CTRI Number |
CTRI/2025/04/084952 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Blockbuster LMA and Air Q LMA for blind tracheal intubation in patients undergoing elective surgery: A prospective study |
|
Scientific Title of Study
|
Prospective study to compare the Blockbuster LMA and the Air Q LMA as a conduit for blind tracheal intubationin patients scheduled for elective surgery under general anaesthesia |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranya Singla |
| Designation |
Anaesthesia Resident |
| Affiliation |
Maharishi Markandeshwar University |
| Address |
Department of Anaesthesia, MM institute of Medical Sciences and Research Centre, Mullana, Ambala, Haryana
Ambala HARYANA 133207 India |
| Phone |
9158508104 |
| Fax |
|
| Email |
pranya.singla@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sapna Bansal |
| Designation |
HOD and professor |
| Affiliation |
Maharishi Markandeshwar University |
| Address |
Department of Anaesthesia, MM institute of Medical Sciences and Research Centre, Mullana, Ambala, Haryana
Ambala HARYANA 133207 India |
| Phone |
8168381441 |
| Fax |
|
| Email |
drsapna10@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sapna Bansal |
| Designation |
HOD and professor |
| Affiliation |
Maharishi Markandeshwar University |
| Address |
Department of Anaesthesia, MM institute of Medical Sciences and Research Centre, Mullana, Ambala, Haryana
Ambala HARYANA 133207 India |
| Phone |
8168381441 |
| Fax |
|
| Email |
drsapna10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, MM Institute of Medical Sciences and Research Centre, Mullana, Ambala, (Haryana) India 133207 |
|
|
Primary Sponsor
|
| Name |
Doctor Sapna Bansal HOD and Professor of Department of Anaesthesia |
| Address |
HOD and professor of Department of Anaesthesia, MM Institute of Medical Sciences and Research Centre, Mullana, Ambala, Haryana, India 133207 |
| 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 Pranya Singla |
MM Institute of Medical Sciences and Research Centre |
Department of Anaesthesia, MM Institute of Medical Sciences and Research Centre, IInd floor,Near OT complex, Old Building , Mullana, Mala , Haryana (India) 133207 Ambala HARYANA |
9158508104
pranya.singla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Co MMIMSR, mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Posted for elective surgeries under General Anaesthesia
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Blind tracheal intubation via AirQ LMA |
Group B undergoes blind tracheal intubation using an appropriate sized endotracheal tube using AirQ LMA as a conduit |
| Intervention |
Blind tracheal intubation via Blockbuster LMA |
Group A undergoes blind tracheal intubation using an appropriate sized endotracheal tube using Blockbuster LMA as a conduit at the beginning of elective surgery under general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Either gender of age 18-60 years and ASA grade I and II status with modified Mallampatti grade I,II or III, scheduled for elective surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. ASA III and IV
2. Obese patients with BMI >40
3. Anticipated difficult airway (Incisior distance <3cm, MPG grade IV, restricted neck movements)
4. ptients refused to give consent.
5. pregnant females
6. those planned for rapid sequence intubation
7. increased risk of pulmonary aspiration with gastric content
8. patients with complaints of sore throat, oral or laryngeal pathology |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the comparion of successful intubations, time taken for intubation, number of attepmts and post operative complications |
Peroperative( baseline), at the time of intubation , 1 min after Endotracheal tube insertion, 3 min after ETT insertionn and 5 min after ETT insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| |
|
| to study ease of insertion of ETT via LMA & to detect failure of LMA insertion or ETT insertion. |
preoperative(baseline) vitals measurement, intubation via alternate mathods & time taken, post operative vital measurement |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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 3 |
|
Date of First Enrollment (India)
|
27/04/2025 |
| 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="0" Months="5" 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
|
Airway management remains a vital
primary skill for anaesthetist. Rapid placement of a reliable airway is the
most important task in anesthesia practice. Airway management is a critical
skill to provide safe anesthesia .
Airway management in patients undergoing general anesthesia is a set of actions
that result in the creation of a safe and secure airway for ventilation.
Failure in the airway management and hypoxia can lead to irreversible brain
damage within only a few minutes. Therefore, establishing a fast and secure
airway is one of the most important tasks of an anesthesiologist.
The main reason for failure in
laryngoscopy is the anatomical condition of the patient and the physician’s
experience in performing a laryngoscopy. The availability of alternative
equipment and methods may increase the success rate for anesthesiologists.
Many devices and instruments have been introduced and used to make intubation
an easier and simple technique. In the events of failure to intubate and
failure to ventilate, LMA play a critical role. LMA are inserted up to glottic
entry via oral route and can be used in conditions when tracheal intubations
and mask ventilations are challenging. Over the years,
the single-tube supraglottic airway device (SGD) design transformed into
dual-lumen intubating conduits and assumed an advanced role in airway
management. New SGDs have roles beyond airway maintenance, including airway
rescue after failed intubation or failed ventilation.
SGDs are recommended to be used as
intubation conduits by Difficult airway society guidelines. With the
availability of different intubating SGD designs over the years, it is
essential to understand which device serves as a better intubating conduit. Blockbuster LMA (Tuoren medical
instrument co ltd, Chang yuan city, China) introduced in 2012 by Professor Ming
Tian, is designed to provide high airway seal pressures and increased green
channel for intubation.(2)
2. Air Q LMA (Cook gas LLC, Mercury
Medical, Clearwater, FL, USA) introduced by Daniel Cook in 2005 is a
supraglottic airway device with shorter and wider breathing tube designed for
ventilation as well as intubation in anticipated as well as unanticipated
difficult airway. The design of both these LMAs provide an unobstructed
pathway for passage of endotracheal tube by providing favorable alignment with
the glottic inlet. It is
necessary to assess their safety and their performance . Many authors have studied regarding the utility of
blockbuster LMA and Air Q LMA separately. However, there is a paucity in the
literature in regards to comparing the above devices in regards to success of
endotracheal intubation. Therefore, the purpose of conducting this study is to
compare the efficacy of blind endotracheal intubation through Blockbuster and
Air Q LMA in terms of successful tracheal intubation, time taken for intubation,
number of attempts and post operative complications associated. |