| CTRI Number |
CTRI/2025/01/079214 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of endotracheal intubation through two different supraglottic airway devices with fiberoptic guidance |
|
Scientific Title of Study
|
Comparison of endotracheal intubation through BlockBuster® versus Fastrach® LMA (Laryngeal Mask Airway) with fiberoptic guidance |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rudhra Jayachandran |
| Designation |
JRD Anaesthesia |
| Affiliation |
Bhabha Atomic Research Centre Hospital |
| Address |
BARC Hospital
Bhabha Atomic Research Centre Anushakti Nagar
Mumbai
Mumbai
MAHARASHTRA
400094
India |
| Phone |
9566278071 |
| Fax |
|
| Email |
medico.rudy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kajal Dalal |
| Designation |
Full time consultant |
| Affiliation |
Bhabha Atomic Research Centre Hospital |
| Address |
BARC Hospital
Bhabha Atomic Research Centre Anushakti Nagar
Mumbai
Mumbai
MAHARASHTRA
400094
India |
| Phone |
9821577175 |
| Fax |
|
| Email |
ksdalal@barc.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rudhra Jayachandran |
| Designation |
JRD Anaesthesia |
| Affiliation |
Bhabha Atomic Research Centre Hospital |
| Address |
BARC Hospital
Bhabha Atomic Research Centre Anushakti Nagar
Mumbai
Mumbai
MAHARASHTRA
400094
India |
| Phone |
9566278071 |
| Fax |
|
| Email |
medico.rudy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhabha Atomic Research Centre hospital, Anushakti nagar, Mumbai, Maharashtra-400094, India |
|
|
Primary Sponsor
|
| Name |
BARC hospital |
| Address |
BARC hospital
Bhabha Atomic Research Centre
Anushakti nagar
Mumbai
600094 |
| Type of Sponsor |
Other [DNB teaching institute] |
|
|
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 |
| Rudhra Jayachandran |
Bhabha Atomic Research Centre hospital |
Main operation theater
Second floor
Anaesthesia department
BARC hospital
Anushakti nagar
Mumbai 400094
Mumbai (Suburban)
MAHARASHTRA |
9566278071
medico.rudy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BARC Hospital Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endotracheal intubation through BlockBuster® LMA (Laryngeal Mask Airway) with fiberoptic guidance |
Ease of endotracheal intubation through BlockBuster® LMA (Laryngeal Mask Airway) with fiberoptic guidance. An easy intubation will be sucessful endotracheal tube placement in one attempt, difficult intubation will be successful tube placement requiring more than one attempt and if trachea is not able to be intubated through LMA in three attempts, it will be labelled as failure and surgery will be continued with endotracheal intubation following direct laryngoscopy. |
| Intervention |
Endotracheal intubation through Fastrach® LMA (Laryngeal Mask Airway) with fiberoptic guidance |
Ease of endotracheal intubation through Fastrach® LMA (Laryngeal Mask Airway) with fiberoptic guidance. An easy intubation will be sucessful endotracheal tube placement in one attempt, difficult intubation will be successful tube placement requiring more than one attempt and if trachea is not able to be intubated through LMA in three attempts, it will be labelled as failure and surgery will be continued with endotracheal intubation following direct laryngoscopy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (age: 18-60yrs).
Patients with ASA physical status I to III.
Patients with adequate mouth opening of at least 3cms.
|
|
| ExclusionCriteria |
| Details |
Oropharyngeal pathology
Morbid obesity
Pregnancy
Patients with gastroesophageal reflux
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for intubation and ease of tracheal intubation |
minutes, seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time taken for LMA placement.
2. Ease of insertion of LMA.
3. Time required for removal of LMA.
4. Blood on laryngeal mask airway and sore throat.
|
minutes, seconds |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2025 |
| Date of Study Completion (India) |
21/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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)?
Response - NO
|
Brief Summary
Modification(s)
|
A prospective, randomized, comparative study to compare the ease of intubation through Blockbuster LMA versus Fastrach LMA with fiberoptic guidance in patients undergoing elective surgery under general anaesthesia. The ease of intubation was measured based on time taken to intubate and the number of attempts taken to intubate. The grade of fiberoptic view of the glottis, presence of blood on the LMA and sore throat before discharge from recovery room were also be noted. The time for insertion was noted from picking of LMA till adequate ventilation is established with square wave capnogram. Ease of insertion of the LMA was graded as easy, difficult or failure. An easy insertion is defined as placement without resistance following a single attempt. More than one attempt will be considered a difficult insertion. A failed insertion will be defined as failure to insert the device after three attempts. The score of the bronchoscopic view of the glottis was noted Brimacombe score: 1. vocal cords not seen 2. cords with anterior epiglottis seen 3. cords plus posterior epiglottis seen 4. only cords visible The ease of ETT placement was noted. Time required for the ETT placement was noted (the time interval between picking up the fiberscope loaded with ETT till square wave capnogram is seen). Time required to remove LMA was noted. After LMA removal, the tube cuff was reinflated and connected to the ventilator circuit and anaesthesia will be continued by balanced general anaesthesia. Damage or blood on cuff of LMA was noted. After the surgery is completed, presence of sore throat was recorded. |