| CTRI Number |
CTRI/2022/01/039817 [Registered on: 28/01/2022] Trial Registered Prospectively |
| Last Modified On: |
13/02/2022 |
| 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
|
COMPARATIVE EVALUATION OF BLIND TRACHEAL INTUBATION
VIA TWO SUPRAGLOTTIC AIRWAY DEVICE |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF INTUBATING LARYNGEAL MASK AIRWAY (FASTRACH) AND BLOCKBUSTER LARYNGEAL MASK AIRWAY FOR BLIND TRACHEAL INTUBATION IN GENERAL SURGICAL OPERATIONS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arshdeep Singh |
| Designation |
Resident |
| Affiliation |
Department of Anaesthesia, GMC Amritsar |
| Address |
45-Nagina Avenue, Majitha road
Amritsar
PUNJAB
143001
India |
| Phone |
|
| Fax |
|
| Email |
drarshdeep95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajan Kumar |
| Designation |
Associate Professor |
| Affiliation |
Department of Anaesthesia, GMC Amritsar |
| Address |
Majitha road
Amritsar
PUNJAB
143001
India |
| Phone |
|
| Fax |
|
| Email |
rajan.verma0102@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arshdeep Singh |
| Designation |
Resident |
| Affiliation |
Department of Anaesthesia, GMC Amritsar |
| Address |
45-Nagina Avenue, Majitha road
Amritsar
PUNJAB
143001
India |
| Phone |
|
| Fax |
|
| Email |
drarshdeep95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Government Medical College, Amritsar |
|
|
Primary Sponsor
|
| Name |
Dr Rajan Verma |
| Address |
Government Medical College Amritsar |
| Type of Sponsor |
Other [Equipments] |
|
|
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 |
| Arshdeep Singh |
Guru Nanak Dev Hospital |
Department of Anaesthesia, Government Mendical College, Majitha Road Amritsar
Amritsar
PUNJAB |
8447981110
drarshdeep95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe |
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 |
Blind tracheal intubation |
Patients presenting for general surgery will be intubated blindly using either Fastrach or the Blockbuster LMA |
| Comparator Agent |
Blind tracheal intubation through Fastrach LMA |
overall efficacy and success rate of blind tracheal intubation through Fastrach LMA. Blind tracheal intubation will be attempted after successful insertion of Fastrach LMA |
| Comparator Agent |
Blockbuster LMA |
Overall efficacy and success rate of blind tracheal intubation through blockbuster LMA. Blind tracheal intubation will be attempted after successful insertion of Blockbuster LMA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1&2
MPG 1&2 |
|
| ExclusionCriteria |
| Details |
Pregnant patients
Patients with oropharyngeal pathology |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Time taken for LMA insertion
2. Time taken for blind tracheal intubation
3.Overall success rate of blind tracheal intubation |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the change in hemodynamics
To assess any complications during insertion or removal of LMA or any post operative complications. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
31/01/2022 |
| 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="0"
Months="0"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Airway management is most important skill an anaesthetist has to acquire. However the latest LMAs are suitable alternative through which blind tracheal intubation can be attempted and which do not require expertise. Therefore we are comparing the efficacy of two different LMAs that is the fastrach LMA and the blockbuster LMA for their overall efficacy and success rate of blind tracheal intubation |