| CTRI Number |
CTRI/2024/05/067364 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study Between LMA Blockbuster and LMA Protector as conduit for blind
Tracheal Intubation in patients undergoing operative procedures in general anaesthesia. |
|
Scientific Title of Study
|
A Comparative Study Between LMA Blockbuster and LMA Protector as conduit for Blind Tracheal Intubation in patients undergoing General Anaesthesia -A Prospective Randomised Controlled 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 |
DEEKSHA SINGH |
| Designation |
Junior Resident |
| Affiliation |
Jawahar Lal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology and Critical Care, Jawahar Lal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7906968138 |
| Fax |
|
| Email |
singhdeeksha207@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Moied Ahmed |
| Designation |
Professor |
| Affiliation |
Jawahar Lal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology and Critical Care Jawahar Lal Nehru Medical College and Hospital Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897454739 |
| Fax |
|
| Email |
syedmoiedahmed123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DEEKSHA SINGH |
| Designation |
Junior Resident |
| Affiliation |
Jawahar Lal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology and Critical Care, Jawahar Lal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7906968138 |
| Fax |
|
| Email |
singhdeeksha207@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care, Jawahar Lal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care JNMCHAMU ALIGARH |
| Address |
Department of Anaesthesiology and Critical Care, JNMCH,AMU, ALIGARH |
| Type of Sponsor |
Government 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 Deeksha Singh |
Jawaharlal Nehru Medical College and Hospital,AMU,Aligarh |
Department of Anaesthesiology and Critical care ,Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh
Aligarh
UTTAR PRADESH |
7906968138
singhdeeksha207@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Faculty of Medicine, AMU, Aligarh ee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 2||Placement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LMA Blockbuster |
Blind intuibation via LMA Blockbuster will be done in patients undergoing operative procedures in general anaesthesia. Intubation will be done through LMA Blockbuster with size 7/8 flexometallic tube which will be supplied with LMA Blockbuster size 3/4 respectively. Successful placement will be confirmed by the ability to achieve tidal volume of at least 7-8 ml/kg with a square wave capnogram. |
| Intervention |
LMA Protector |
Blind intuibation via LMA Protector will be done in patients undergoing operative procedures in general anaesthesia. Intubation will be done through LMA Protector with size 7/8 flexometallic tube which will be supplied with LMA Blockbuster size 3/4 respectively.
Successful placement will be confirmed by the ability to achieve tidal volume of at least 7-8 ml/kg with a square wave capnogram. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I & II patients
Age between 20-70 years
Weight between 40-70 kg
Patients of both sexes
All classes of MP Grades
|
|
| ExclusionCriteria |
| Details |
Any pathology of the oral cavity that may obstruct the insertion of device
Mouth opening less than 2.5cm
Potentially full stomach patients (trauma morbid obesity history of gastric regurgitation and heart burn full term pregnancy)
•risk of oesophageal reflux (hiatus hernia).
•Bleeding disorder.
•Patients having Cardiorespiratory problems.
•Unable to provide informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of first attempt success rate of blind intubation through LMA Blockbuster and LMA Protector |
It will be considered only when the endotracheal tube will be inserted into green channel of LMA until the confirmation through capnographic waveform in first attempt
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of time for successful tracheal intubation |
The time for successful tracheal intubation will be started when the endotracheal tube will be inserted into the green channel of LMA until the confirmation through capnographic waveform.Time for first intubation attempt will be measured only |
| Number of attempts taken for intubation |
More than 2 attempts will be considered as failure of blind intubation and ventilation was continued through LMA. |
Number of Manouvers required to intubate through Supraglottic device
|
Chandy manouvre
Jaw thrust manouver
|
| Hemodynamic changes |
pulse rate, SBP, DBP, MAP, SpO2 will be noted before and after (immediately, 1min & 5min) device insertion |
| Complications |
Number of patients complaining of immediate sore throat.
blood staining on the device – yes/no.
Number of patients complaining of vomiting will be noted.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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="2"
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
|
A randomised controlled study to compare the success rate of LMA Blockbuster and LMA Protector as conduit for blind tracheal intubation in patients undergoing operative procedures in general anaesthesia The first attempt success rate is very high with majority of supraglottic devices This makes supraglottic airway devices an indispensible gadget in difficult airway management armamenterium However 2nd generation supraglottic devices are being extensively used in elective anaesthetic cases The recently introduced supraglottic devices are LMA Protector and LMA Blockbuster there are studies on blind intubation via LMA Blockbuster . However , there is no controlled study on LMA Protector as conduit for intubation So We are comparing the first attempt success rate of blind intubation through LMA Protector and LMA blockbuster- this is our primary aim of study |