| CTRI Number |
CTRI/2022/12/047958 [Registered on: 08/12/2022] Trial Registered Prospectively |
| Last Modified On: |
25/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of the LMA BlockBuster with LMA Protector as a conduit for blind endotracheal intubation in patients undergoing elective surgery under general anaesthesia |
|
Scientific Title of Study
|
A randomized controlled trial to compare the BlockBusterTM Laryngeal Mask with LMA® ProtectorTM Airway as a conduit for blind endotracheal intubation in patients undergoing elective surgery under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Navneeth Nakshatri |
| Designation |
PG resident |
| Affiliation |
Lady Hardinge Medical College |
| Address |
DEPARTMENT OF ANAESTHESIA, LADY HARDINGE MEDICAL COLLEGE, NEW DELHI
Central
DELHI
110001
India |
| Phone |
8527585356 |
| Fax |
|
| Email |
drnavneethnakshatri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RANJU SINGH |
| Designation |
DIRECTOR PROFFESOR |
| Affiliation |
Lady hardinge Medical college |
| Address |
DEPARTMENT OF ANAESTHESIA, LADY HARDINGE MEDICAL COLLEGE, NEW DELHI
Central
DELHI
110001
India |
| Phone |
9811151285 |
| Fax |
|
| Email |
ranjusingh1503@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
NAVNEETH NAKSHATRI |
| Designation |
PG RESIDENT |
| Affiliation |
Lady Hardinge Medical College |
| Address |
DEPARTMENT OF ANAESTHESIA, LADY HARDINGE MEDICAL COLLEGE, NEW DELHI
Central
DELHI
110001
India |
| Phone |
8527585356 |
| Fax |
|
| Email |
drnavneethnakshatri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Lady Hardinge Medical College |
|
|
Primary Sponsor
|
| Name |
Departmen of Anaesthesia,Lady hardinge medical college |
| Address |
Department of anaesthesia, lady hardinge medical college, Shahid Bhagat Singh Marg, New Delhi 110001 |
| Type of Sponsor |
Government medical college |
|
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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 |
| NAVNEETH NAKSHATRI |
Lady Hardinge Medical College |
Department of anaesthesia
Central
DELHI |
8527585356
drnavneethnakshatri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Lady Hardinge Medical College and Associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blind endotracheal intubation through Blockbuster LMA or LMA protector in a patient undergoing elective surgery under general anaesthesia |
Both Blockbuster LMA and LMA Protector airway are intubating type of LMA(supraglottic devices) and facilitate blind endotracheal intubation through them without the need of laryngoscopy. |
| Comparator Agent |
Blind Intubation through Blockbuster Laryngeal mask |
weight appropriate size of Blockbuster LMA will be selected and blind intubation through it will be performed using Blockbuster endotrcheal tube |
| Comparator Agent |
Blind intubation through LMA Protector Airway |
weight appropriate size of LMA Protector will be selected and blind intubation through it will be performed using PVC endotracheal tube |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgery under general anaesthesia and requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1.Anticipated difficult airway
2.Upper respiratory tract infection and
severe pulmonary disease
3.BMI > 35 Kg/m2
4.Mouth opening < 2 cm
5.Risk of regurgitation and aspiration
(GERD, hiatus hernia, non fasting status)
6.Pregnancy
|
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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
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of patients having successful blind endotracheal intubation through BlockBuster™ Laryngeal Mask or through LMA® Protector™ Airway in the first attempt. |
From induction of general anaesthesia to 4 hours post operative period |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of patients with successful SGA placement
Mean time for placement of SGA
Proportion of patients requiring 2nd or 3rd attempt for placement of SGA.
Proportion of patients requiring 2nd or 3rd attempt for intubation through SGA
Mean time taken for intubation
Proportion of patients developing complications |
from induction to 4 hours post operative period |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Results will be published in a scientific journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The supraglottic airways (SGA) are frequently used as the primary device to secure the airway in elective surgeries as well as in recognized difficult airway cases. The SGA can also be used as a rescue device, for restoring oxygenation and ventilation while allowing time to prepare for other airway manoeuvres. The SGAs can also be used as a conduit for tracheal intubation, this technique has been recommended by the Difficult Airway Society (DAS) for difficult airway management . Intubation through these devices is also recommended in the ‘All India Difficult Airway Association’ guidelines . It is also recommended that the intubation through SGAs be done under fibreoptic bronchoscope (FOB) guidance. However, this requires the availability of a FOB and expertise in its use, which may not be possible many times, particularly in the emergency situations managed by residents. Therefore, the new SGAs designed to facilitate blind tracheal intubation are gaining popularity as a bridge connecting ventilation and intubation in all genres of patients. The BlockBuster™ Laryngeal Mask, invented by professor Ming Tian in 2012 has been recently launched in the Indian market and is designed primarily to provide a green channel for the smooth passage of cuffed tracheal tube for blind tracheal intubation . The Laryngeal Mask Airway® (LMA) Protector™ Airway (Teleflex Medical Europe, Westmeath, Ireland) was first used in clinical practice in 2015. It is made of medical-grade silicone with two large volume gastric drainage channels and integrated with a cuff pressure indicator, the Cuff Pilot™ . The easy insertion is attributed to its fixed-curved structure, and its wide internal airway lumen diameter (up to 13 mm) which allows flexibility and thereby enhancing its use as an intubation conduit.Blind intubation through an SGA can be lifesaving in cases of difficult airway. The technique should however be perfected first in patients with normal airways. Considering the limited availability of FOB in emergency situations, the new SGAs designed to facilitate blind tracheal intubation like the BlockBusterTM Laryngeal Mask and LMA® ProtectorTM Airway are gaining popularity. There is very limited published data comparing the first pass success rate of blind endotracheal intubation through the BlockBusterTM Laryngeal Mask with LMA® ProtectorTM Airway in patients undergoing elective surgery under general anaesthesia. Therefore, we planned this study to compare the first pass success rate of blind endotracheal intubation through both these devices. The ease, number of attempts and time taken for the placement of SGA, number of attempts, manoeuvres required and time taken to intubate through the SGA and complications will also be compared using the BlockBusterTM Laryngeal Mask with LMA® ProtectorTM Airway.
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