| CTRI Number |
CTRI/2021/12/038727 [Registered on: 17/12/2021] Trial Registered Prospectively |
| Last Modified On: |
28/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparision of BlockBuster LMA intubating LMA |
|
Scientific Title of Study
|
A study to compare the ease of intubation using intubating
LMA and LMA BlockBuster |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kiranpreet Kaur |
| Designation |
Professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of Anaesthesiology and critical care
Pt. B.D. Sharma PGIMS Rohtak
Rohtak
Haryana
Department of Anaesthesiology and critical care
Pt. B.D. Sharma PGIMS Rohtak
Rohtak
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9467807441 |
| Fax |
|
| Email |
kiranpreet72@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiranpreet Kaur |
| Designation |
Professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of Anaesthesiology and critical care
Pt. B.D. Sharma PGIMS Rohtak
Rohtak
Haryana
Department of Anaesthesiology and critical care
Pt. B.D. Sharma PGIMS Rohtak
Rohtak
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9467807441 |
| Fax |
|
| Email |
kiranpreet72@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishvas Verma |
| Designation |
Junior Resident |
| Affiliation |
PGIMS Rohtak |
| Address |
Doctors hostel
Department of Anaesthesiology and critical care
Pt. B.D. Sharma PGIMS Rohtak
Rohtak
Haryana
Doctors hostel
Department of Anaesthesiology and critical care
Pt. B.D. Sharma PGIMS Rohtak
Rohtak
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9467807441 |
| Fax |
|
| Email |
vermavishvas30@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTIONAL, Pt. B.D. Sharma PGIMS Rohtak
Rohtak
Haryana |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and critical care |
| Address |
Pt. B.D. Sharma PGIMS Rohtak
Rohtak
Haryana |
| 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 |
| Vishvas Verma |
PGIMS Rohtak |
Department of Anaesthesiology and Critical care, Pt. B.D. Sharma PGIMS Rohtak
Haryana
Rohtak
HARYANA |
9467807441
vermavishvas30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
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 |
BlockBuster LMA |
Peripheral intravenous line will be
secured with appropriate sized cannula. Pre-oxygenation for 3 minutes will be done with
100% oxygen. Induction of anaesthesia will be done with glycopyrrolate (0.005mgkg-1
),
fentanyl (2µkg-1
) and propofol (2.5mgkg-1
). After achieving adequacy of ventilation,
12
neuromuscular blockade will be achieved with vecuronium (0.1mgkg-1
). Patient will be
ventilated for 3 minutes via facemask and anaesthesia breathing system with 100% oxygen
and 2% sevoflurane. An appropriate size of BlockBuster LMA(size 3 or
4) will be selected according to weight. Airway
device will be checked before use and lubricated. Airway devices will be introduced using the standard technique for insertion. After correct placement of BlockBuster LMA endotracheal tube will be inserted. |
| Comparator Agent |
Intubating LMA |
Peripheral intravenous line will be
secured with appropriate sized cannula. Pre-oxygenation for 3 minutes will be done with
100% oxygen. Induction of anaesthesia will be done with glycopyrrolate (0.005mgkg-1
),
fentanyl (2µkg-1
) and propofol (2.5mgkg-1
). After achieving adequacy of ventilation,
12
neuromuscular blockade will be achieved with vecuronium (0.1mgkg-1
). Patient will be
ventilated for 3 minutes via facemask and anaesthesia breathing system with 100% oxygen
and 2% sevoflurane. An appropriate size of intubating LMA(size 3 or
4) will be selected according to weight. Airway
device will be checked before use and lubricated. Airway devices will be introduced using the standard technique for insertion.After correct placement of Intubating LMA endotracheal tube will be inserted. LMA removed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Sixty patients of either sex aged 18-60 years belonging to American
Society of Anaesthesiologists (ASA) physical status 1 or 2 scheduled for elective surgery
under general anaesthesia requiring endotracheal intubation will be included in the study.
|
|
| ExclusionCriteria |
| Details |
atients having respiratory or pharyngeal pathology, mouth opening
<2.5cms, Body mass index >30kgm
-2
, pregnancy, full stomach, anticipated difficult airway
will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
success rate of intubation
|
ease of intubation will be assessed for both intubating and BlockBuster LMA. Data will be compiled and appropriate statistical test will be used to analyse the results. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Success of placement of LMA
Time taken for intubation
Number of attempts
ï‚· Haemodynamic variation
ï‚· Pharyngo-laryngo morbidity |
Following will be assessed for both intubating and BlockBuster LMA. Data will be compiled and appropriate statistical test will be used to analyse the results. |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
28/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/12/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
our study is to compare the first pass success rate and ease of blind tracheal intubation through Intubating LMA and BlockBuster LMA |