| CTRI Number |
CTRI/2024/04/065357 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of blind approach with direct vision for successful intubation through airway device in adult patients undergoing surgery. |
|
Scientific Title of Study
|
A Comparison of blind intubation with fiberoptic guided intubation through Blockbuster(TM) Laryngeal Mask Airway using PolyVinylChloride Tube in Adults |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujata Chaudhary |
| Designation |
Director Professor |
| Affiliation |
Guru Gobind Singh Indraprastha University |
| Address |
room no. 6, HOD room,
Department of Anaesthesiology & Intensive Care,
Vardhman Mahavir Medical College and Safdarjung Hospital
Ansari nagar west, New Delhi
South
DELHI
110029
India |
| Phone |
9999051546 |
| Fax |
|
| Email |
sujatac462@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Chaudhary |
| Designation |
Director Professor |
| Affiliation |
Guru Gobind Singh Indraprastha University |
| Address |
room number 6, HOD room,
Vardhman Mahavir Medical College and Safdarjung Hospital
Ansari nagar west, New Delhi
South
DELHI
110029
India |
| Phone |
9999051546 |
| Fax |
|
| Email |
sujatac462@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Chaudhary |
| Designation |
Director Professor |
| Affiliation |
Guru Gobind Singh Indraprastha University |
| Address |
room no. 6, HOD room,
Department of Anaesthesiology & Intensive Care
Vardhman Mahavir Medical College and Safdarjung Hospital
Ansari nagar west, New Delhi
South
DELHI
110029
India |
| Phone |
9999051546 |
| Fax |
|
| Email |
sujatac462@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology & Intensive Care,
Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology Intensive Care |
| Address |
Vardhman Mahavir Medical College & Safdarjung Hospital,
Ansari Nagar West, New Delhi |
| 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 Kamal Sourav |
Vardhman Mahavir Medical College & Safdarjung Hospital |
room number 6, HOD room,
Department of Anaesthesiology,
Vardhman Mahavir Medical College and Safdarjung Hospital
Ansari Nagar West, New Delhi 110029
South
DELHI |
7678494023
kamalsourav24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vardhman Mahavir Medical College & Safdarjung hospital, Ministry of Health & Family Welfare, Government of India |
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 intubation through Blockbuster Laryngeal Mask Airway |
Blind intubation through Blockbuster Laryngeal Mask Airway Device using PolyVinylChloride Tube in adults.
total duration of study will be 18 months. |
| Comparator Agent |
Fiberoptic guided intubation thourgh Blockbuster laryngeal mask airway |
FIberoptic guided intubation through Blockbuster Laryngeal Mask Airway Device using PolyVinylChloride Tube in adults.
total duration of study will be 18 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients belonging to American Society of Anaesthesiologists (ASA) grade I & II; aged between 18yrs to 60yrs of both the genders, undergoing elective surgery of less than 3 hours anticipated duration of surgery requiring General Anaesthesia with orotracheal intubation with supine position intra-operatively. |
|
| ExclusionCriteria |
| Details |
•Predicted difficult airway
•Increased aspiration risk- Recent trauma, full stomach, pregnancy, intestinal obstruction, gastroesophageal reflux disease
|
|
|
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 first pass success rate of blind intubation with that of fiberoptic guided intubation through BlockbusterTM laryngeal mask airway device, using polyvinyl chloride endotracheal tube. |
Preop, at time of insertion of blockbuster LMA, at time of endotracheal intubation thorugh blockbuster LMA, 1 min after insertion, 3 min after insertion, 5 min after insertion, 10 min after insertion, at time of extubation & in post anaesthesia care unit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
I. Endotracheal tube Insertion characteristics
a) Ease of insertion
b) Number of attempts for successful intubation
c) Time taken for intubation
d) Manuevers required for tube insertion
II. Hemodynamic changes – Blood Pressure(Systolic Blood
Pressure/Diastolic Blood Pressre), Heart Rate, Oxygen
Saturation changes
|
Hemodynamics changes as secondary outcome will be measured : Preop, at time of insertion of blockbuster LMA, at time of endotracheal intubation thorugh blockbuster LMA, 1 min after insertion, 3 min after insertion, 5 min after insertion, 10 min after insertion, at time of extubation & in post anaesthesia care unit |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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 3 |
|
Date of First Enrollment (India)
|
16/04/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kamalsourav24@gmail.com].
- For how long will this data be available start date provided 26-03-2024 and end date provided 26-03-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This study is randomized, double blind parallel group trial to compare Blind intubation with Fiberoptic guided intubation through Blockbuster laryngeal mask airway using polyvinylchloride tube in adults patient that will be conducted at Department of Anaesthesiology & Intensive Care, Safdarjung Hospital and Vardhman Mahavir Medical College, New Delhi for 18 months after seeking clearance from Institutional Ethics Committee. This study includes patients belonging to ASA Grade I & II aged between 18yrs to 60yrs of both genders undergoing elective surgery of less than 3 hours anticipated duration of surgery requiring General Anaesthesia with orotracheal intubation with supine postion intraoperatively. The primary outcome measures the first pass success rate of blind intubation with that of fiberoptic guided intubation through blockbuster LMA. The secondary outcome will be measuring endotracheal tube insertion characteristics i.e. ease of insertion, number of attempts for successful intubation, time taken for intubation, manuevers required for tube insertion & will also measure hemodynamic changes i.e. Blood Pressure change(Systolic BP/Diastolic BP), Heart rate changes, oxygen saturation changes. We hypothesise from this study that the blind intubation is similar to fiberoptic guided intubation through blockbuster LMA using PolyVinylChloride Tube in adults. |