| CTRI Number |
CTRI/2019/03/018250 [Registered on: 25/03/2019] Trial Registered Prospectively |
| Last Modified On: |
29/11/2019 |
| 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
|
Securing airway through two different supraglottic devices under general anaesthesia |
|
Scientific Title of Study
|
Efficacy of blockbuster LMA in comparison to fastrach LMA as a conduit for blind tracheal intubation: A single blind prospective randomized clinical study |
| Trial Acronym |
LMA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archana Endigeri |
| Designation |
Assistant Professor |
| Affiliation |
S Nijalingappa Medical college |
| Address |
Department of Anesthesiology
S N Medical college and HSK Hospital Navanagar Bagalkot
Department of Anesthesiology
Bagalkot
KARNATAKA
587102
India |
| Phone |
7406568382 |
| Fax |
|
| Email |
archanaendigeri86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Archana Endigeri |
| Designation |
Assistant Professor |
| Affiliation |
S Nijalingappa Medical college |
| Address |
Department of Anesthesiology
S N Medical college and HSK Hospital Navanagar Bagalkot
Department of Anesthesiology
Bagalkot
KARNATAKA
587102
India |
| Phone |
7406568382 |
| Fax |
|
| Email |
archanaendigeri86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Archana Endigeri |
| Designation |
Assistant Professor |
| Affiliation |
S Nijalingappa Medical college |
| Address |
Department of Anesthesiology
S N Medical college and HSK Hospital Navanagar Bagalkot
Department of Anesthesiology
Bagalkot
KARNATAKA
587102
India |
| Phone |
7406568382 |
| Fax |
|
| Email |
archanaendigeri86@gmail.com |
|
|
Source of Monetary or Material Support
|
| S N Medical college and HSK Hospital
Navanagar
Bagalkot 587102
Karnataka state |
|
|
Primary Sponsor
|
| Name |
S Nijalingappa Medical college |
| Address |
Department of anaesthesiology
S N Medical college
Navanagar Bagalkot |
| 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 Bodepu Venkat Satya Varaprasad |
S N Medical college and HSK Hospital |
Department of
Anaesthesiology 2nd
floor Major OT complex
S Nijalingappa Medical
College and HSK
Hospital
Bagalkot
KARNATAKA
Bagalkot
KARNATAKA |
9108704745
varaprasad909@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SNMC- INSTITUTIONAL ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z000||Encounter for general adult medical examination, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blind intubation technique through supraglottic airway devices |
Comparison of ease of blind tracheal intubation through supraglottic airway devices which will reduce haemodynamic response with lesser patient related complications which is useful in cardiac morbid patients. |
| Comparator Agent |
Comparison of intubation technique through fastrach and blockbuster LMA |
Comparing two supraglottic devices for the ease of Blind endotracheal intubation through Fastrach and blockbuster LMA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA status I-III
Mallampatti grade I-III
Elective and emergency surgeries performed under general anesthesia
BMI <35
|
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA status IV
Mallampatti grade IV
Mouth opening <2cm
Morbid obesity
Pregnancy
Upper respiratory tract infection
Previous airway surgery
Patient at risk of regurgitation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Successful blind tracheal intubation through both LMAs |
20 SECONDS AFTER LMA INSERTION |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ease of Lma insertion
Time for insertion of LMA and intubation
Attempts taken for insertion of LMA and endotracheal tube
First pass successful intubation
Time for LMA removal
Haemodynamic stability
Complicationc |
5 MINUTES AFTER INDUCTION |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2019 |
| Date of Study Completion (India) |
20/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Yunluo L,Yuan Z,Yajie X et al,Nanjing Hospital,China,
have conducted a comparative study between Block Buster LMA and Proseal LMA in 42 pateints undergoing urologic day care surgeries.
They have concluded that compared to proseal LMA, Block Buster LMA has excellent ventilation function and excellent blind tracheal intubation |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
BlockBuster LMA, A newer supraglottic airway device, is claimed to be an efficient conduit for endotracheal intubation. Intubating LMA is an established device for the same. This randomised study was undertaken to evaluate the success rate of blind tracheal intubation using either of these LMAs. Methods : Sixty patients of age group 20-60 years undergoing general anaesthesia were randomised into 2 groups, of 30 patients each, for tracheal intubation using either BlockBuster LMA or Intubating LMA. After induction of anaesthesia, LMAs were inserted and on achieving adequate ventilation with the device, blind intubation was attempted through the suprglottic airway devices. The primary objective was first pass successful intubation and secondary outcomes were ease and time for LMA insertion, oropharyngeal seal pressure (OSP) and complications. Data was analysed using SPSS V22 software. Results First attempt success rate of tracheal intubation was 90% in Group B and 66.6% in Group F (P=0.028), while the oeral success rate of intubation was 90% in Group B and 89.9% in Group F (P=0.3). The OSP in Group G was 33.7 and 22 cm H20 in Group F (P=0.001). Complications were less with BlockBuster LMA. Conclusion : BlockBuster LMA provides higher first pass success rate of blind tracheal intubation with less complications. |