| CTRI Number |
CTRI/2018/02/011947 [Registered on: 19/02/2018] Trial Registered Prospectively |
| Last Modified On: |
11/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A research to evaluate and compare two medical devices (Blockbuster and Fastrach Laryngeal Mask Airway), used to ventilate patients undergoing surgery. |
|
Scientific Title of Study
|
Comparative evaluation of BlockBuster and
Fastrach Laryngeal Mask Airway for
endotracheal intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun Kumaar |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government medical college and hospital, chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, sector 32, Chandigarh
Chandigarh CHANDIGARH 160031 India |
| Phone |
9944357333 |
| Fax |
|
| Email |
arundec06@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Lakesh K Anand |
| Designation |
Professor |
| Affiliation |
Government medical college and hospital, chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, sector 32, Chandigarh
Chandigarh CHANDIGARH 160031 India |
| Phone |
9646121522 |
| Fax |
|
| Email |
lkanand11@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Arun Kumaar |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government medical college and hospital, chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, sector 32, Chandigarh
Chandigarh CHANDIGARH 160031 India |
| Phone |
9944357333 |
| Fax |
|
| Email |
arundec06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, sector 32, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government medical college |
| Address |
Government Medical College and Hospital, sector 32, Chandigarh |
| 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 Arun Kumaar |
Operation theatre |
Operation theatre, Block C,level 2,3 Government medical college and hospital, sector 32, chandigarh Chandigarh CHANDIGARH |
9944357333
arundec06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ( GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All participants will be either ASA ( American Society of Anaesthesiologists) grade 1 or 2., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blockbuster Laryngeal Mask Airway |
Will be used to maintain the patency of airway during general anaesthesia. The device will be inserted only after the induction of anaesthesia. |
| Comparator Agent |
Fastrach Laryngeal Mask Airway |
Will be used to maintain the patency of airway during general anaesthesia. The device will be inserted only after the induction of anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The following patients would be included for the study
1. Age group of 18 to 60 years
2. American Society of Anesthesiologists (ASA) status I and II
3. Patients undergoing elective surgery requiring general anaesthesia with endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
The following patients would be included for the study
1. Morbid obesity BMI > 35 kg/m2
2. Patients with anticipated difficult airway (Airway Difficulty Score>8)
3. Patients at increased risk of aspiration like gastroesophageal reflux, peptic ulcer
4. Previous upper gastrointestinal surgery
5. Coagulopathy or history of anticoagulant use 6. Cardiorespiratory or cerebrovascular disease 7. Cervical spine injury
8. Pregnant patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the success rate of tracheal intubation with BlockBuster and Fastrach Laryngeal Mask Airway. |
immediately after the placement of the device |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare insertion success rates of two Laryngeal Mask Airway’s, oropharyngeal leak pressure, fiberoptic visualization of glottis, hemodynamic parameters and post-operative complication if any.
|
1. Ease of insertion of device, ease of use of gastric tube placement and fiberoptic visualization- will be observed immediately after the placement of the device.
2. Hemodynamic and ventilatory parameters- every minute till 15 min after the placement of device. |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2018 |
| Date of Study Completion (India) |
28/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The
present study entitled “Comparative evaluation of BlockBuster and Fastrach
Laryngeal Mask Airway for endotracheal intubation.â€, was a prospective,
randomised and controlled study done to evaluate and compare the performance of
Blockbuster and LMA Fastrach for tracheal intubation in 100 adult patients of
ASA physical status 1/2 of either sex, in the age group of 18-60 years undergoing
elective surgeries under general anaesthesia. After approval of protocol by
Hospital Ethics Committee, Clinical Trial Registry-India (CTRI/2018/02/011947);
and written informed consent, patients were randomly allocated into following
groups of 50 each:
Group
1 (Blockbuster) (n=50) in which Blockbuster was used
Group
2 (FT-LMA) (n=50) in which LMA Fastrach was used
A
standard monitoring and anaesthetic technique was used for all the patients. All
patients were pre-medicated with inj. Glycopyrrolate 0.2 mg, inj. Midazolam
0.04 mg/kg intravenously, 5 min before induction. After pre-oxygenation for
three minutes, anaesthesia was induced using morphine 0.1 mg/kg, propofol 2.0
to 2.5 mg/kg. After checking for ability to achieve adequate mask ventilation,
vecuronium 0.1 mg/kg was used to facilitate muscle relaxation. After opening
the sealed envelope, the allocated Blockbuster or FT-LMA was inserted. The cuff
was inflated with intracuff pressure of 60 cm H2O; optimal
positioning and ventilation were observed without an audible leak. The
oropharyngeal leak pressure and fibreoptic view of the larynx were determined. A
well lubricated cuffed ETT of appropriate size was inserted blindly to
accomplish intubation. If resistance was felt during blind attempt, the FOB
guided intubation was performed. At confirmation of correct placement of the
tracheal tube, SAD was removed using stabilizing rod to keep tracheal tube in
place.
The
SAD insertion parameters including number of attempts, ease of insertion; time
taken for Blockbuster or FT-LMA insertion; OLP; fibreoptic grading of laryngeal
view; number of attempt and time taken for tracheal intubation; time taken for
SAD removal and blood stained on SAD were noted. Hemodynamic parameters were
obtained at the following time points: baseline; after induction of
anaesthesia; after device insertion, after 1 min, 2 min, 3 min, 4 min, 5 min
and 10 min of tracheal intubation after SAD removal. Postoperative sore throat,
hoarseness of voice, dysphagia in the first post-operative hour was recorded.
The observations were analysed using Statistical Package for Social Sciences (SPSS
Inc., Chicago, IL, version 22.0 for Windows) and the following conclusions were
drawn:
1.
Both the groups were comparable in relation to
the demographic profile of the patients (age, gender, ASA grade, weight,
height, Body mass index).
2.
The number of attempts, time taken and ease of insertion of
Blockbuster and FT-LMA was similar in both the groups.
3.
Mean OLP 28.30±1.89 cm H2O versus 24.46±1.75 cm H2O
in Blockbuster and FT-LMA group respectively.
4.
Fibreoptic view of the vocal cords (grades 4: only vocal cord
seen and 3: vocal cord score plus posterior epiglottis visible) was comparable
in both the groups.
5.
The success of first attempt blind endotracheal intubation
was significantly higher in the Blockbuster (100%) group than the FT-LMA (94%)
group.
6.
No patients in Blockbuster group while 3 (6%) patients in FT-LMA
group required second attempt using FOB.
7.
Time taken for endotracheal intubation was lesser with
Blockbuster group (14.14±2.49 sec) as compared with FT-LMA group (18.34±2.86
sec)
8.
The hemodynamic parameters (HR, SBP, DBP and MAP) at
different point of time were comparable in both the groups. Hemodynamic
parameters increased after one min of intubation in both the groups with lesser
increase in group 1(statistically significant)
9.
The presence of macroscopic blood stain was comparable in both
groups.
10. The incidence and degree
of sore throat was comparable in both the groups. |