| CTRI Number |
CTRI/2020/05/024999 [Registered on: 04/05/2020] Trial Registered Prospectively |
| Last Modified On: |
05/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the passage of breathing tube into the windpipe using, either an IGel or BlockBuster LMA which are two different types of breathing devices |
|
Scientific Title of Study
|
A randomized comparision of fibreoptic guided tracheal intubation through I Gel and BlockBuster laryngeal mask airway |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Kumar Kannaujia |
| Designation |
Associate Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
First Floor, A Block,
Sanjay Gandhi Post Graduate Institute of Medical Sciences,
Rae Bareli Road, Lucknow
Rae Bareli Road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8765974042 |
| Fax |
|
| Email |
ashishkannaujia77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Kumar Kannaujia |
| Designation |
Associate Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
First Floor, A Block,
Sanjay Gandhi Post Graduate Institute of Medical Sciences,
Rae Bareli Road, Lucknow
Rae Bareli Road, Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8765974042 |
| Fax |
|
| Email |
ashishkannaujia77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Kumar Kannaujia |
| Designation |
Associate Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
First Floor, A Block,
Sanjay Gandhi Post Graduate Institute of Medical Sciences,
Rae Bareli Road, Lucknow
Rae Bareli Road, Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8765974042 |
| Fax |
|
| Email |
ashishkannaujia77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post Graduate of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Rae Bareli Road,Lucknow |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ashish Kumar Kannaujia |
Operation Theatre Complex,Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Department of Anaesthesiology, First Floor A Block Rae Bareli Road,Lucknow,226014
Lucknow
UTTAR PRADESH |
8765974042
ashishkannaujia77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Fibreoptic guided endotracheal intubation through BlockBuster LMA |
80 patients based on their position in the random number table will be intubated fibreoptically through BlockBuster LMA |
| Intervention |
Fibreoptic guided endotracheal intubation through IGel |
80 patients based on their position in the random number sequence will be intubated fibreoptically through an IGel |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-II patients,
Body Mass Index <30 kg/m2
All elective surgical procedures requiring tracheal intubation
Adequate mouth opening : >2 fingers
Mallampati Grade 1 - 4
|
|
| ExclusionCriteria |
| Details |
ASA III-V
Body Mass Index>30 kg/m2
Emergency Procedures
Contraindications to supraglottic airway devices |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare success rate of fibreoptic guided tracheal intubation through I-GelTM and BlockBusterTM supraglottic airway devices |
Immediately after confirmed endo tracheal intubation(confirmed by chest rise, capnogram and auscultation) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Insertion time of supraglottic devices
2 Oropharyngeal leak pressure in neutral position
3 Fibreoptic view scoring system
4 Intubation time through the device
5 Incidence of post op complications
|
1 Insertion time of supraglottic devices:After successful placement of IGel or BlockBuster LMA
2.Oropharyngeal leak pressure in neutral position:After successful placement of IGel or BlockBuster LMA
3Fibreoptic view scoring system: After successful placement of IGel or BlockBuster LMA
4 Intubation time through the device: After successful endotracheal intubation fibreoptically through the IGel or BlockBuster LMA
5.Incidence of post op complications: After 24 hours of extubation
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="160" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
20/11/2020 |
| Date of Study Completion (India) |
23/09/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Supraglottic airway devices fill the niche between face mask and tracheal tube in terms of anatomical position,invasiveness and airway security. Various studies exist where supraglottic airway devices have been used as a conduit for passage of endotracheal tubes. However no studies exist which compare BlockBuster LMA with IGel as a conduit for passage of fibreoptic guided endotracheal tube . This study proposes to compare the two devices (IGel and BlockBuster LMA) as conduits for fibreoptic guided endotracheal intubation |