| CTRI Number |
CTRI/2024/06/069451 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
23/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of breathing airway tube insertion with or without fibreoptic help through Ambu AuraGain |
|
Scientific Title of Study
|
A randomised controlled trial comparing tracheal intubation with or without fibreoptic guidance through Ambu AuraGain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vibhor Gupta |
| Designation |
Associate Professor |
| Affiliation |
University College of Medical Sciences and GTB hospital |
| Address |
Department of Aanaesthesiology and Critical care,Dilshad Garden ,Shahdra
East
DELHI
110095
India |
| Phone |
9971068804 |
| Fax |
|
| Email |
vgupta@ucms.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RS Rautela |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences and GTB hospital |
| Address |
Department of Anaesthesiology and Critical care,Dishad Garden ,Shahdra
East
DELHI
110095
India |
| Phone |
9871741419 |
| Fax |
|
| Email |
rsramb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saravana Kumar P |
| Designation |
Postgraduate student |
| Affiliation |
University College of Medical Sciences and GTB hospital |
| Address |
Department of Anaesthesiology and Critical care,Dilshad Garden ,Shahdra
East
DELHI
110095
India |
| Phone |
9003540583 |
| Fax |
|
| Email |
drpsaravanakumarmbbs97@gmail.com |
|
|
Source of Monetary or Material Support
|
| UCMS and GTB hospital, dilshad garden,New Delhi-110095,india |
|
|
Primary Sponsor
|
| Name |
UCMS and GTB hospital |
| Address |
room no 531 B,UCMS and GTB hospital,dilshad garden,shahdra,Delhi,110095,India |
| 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 SARAVANA KUMAR P |
University College Medical Sciences and GTB hospital |
Anaesthesia office room ,2nd floor,OT block,Department of Anaesthesiology and Critical care,Dilshad garden ,Shahdara,East Delhi
East
DELHI |
9003540583
drpsaravanakumarmbbs97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-HUMAN RESEARCH,UNIVERSITY COLLEGE OF MEDICAL SCIENCES,UNIVERSITY OF DELHI,DELHI |
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 |
| Comparator Agent |
Ambu Aura Gain |
Ambu aura gain will be inserted and tracheal intubation with fibreoptic guidance will be performed, once after placement of Ambu Aura Gain |
| Comparator Agent |
Ambu AuraGain |
Ambu aura gain will be inserted and tracheal intubation without fibreoptic guidance will be performed once after placement of Ambu Aura Gain |
| Intervention |
Ambu AuraGain |
Ambu AuraGain will be inserted as the airway management device, once after muscle relaxation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I ,II
Modified Mallampati Class I,II
Patient admitted surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
BMI more than 30kg per meter square,
Pregnant women,
Known or predicted difficult airway,
Known case of COPD, asthma or any other restrictive or obstructive respiratory pathology,
High risk for pulmonary aspiration. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for successful tracheal intubation with or without fibreoptic guidance through Ambu AuraGain |
Once, from disconnection of the circuit from Ambu AUra Gain till reconnecting it with the endotracheal tube |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Number of attempts for successful intubation
|
attempts for successful intubation will be calculated after successful intubation |
| 2.First attempt success rate |
will be calculated after successful intubation is over |
| 3.Ease of endotracheal tube intubation |
graded 1 to 4 after intubation is successful. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
04/07/2024 |
| 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="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
RATIONALE :There is no previous study where Ambu aura gain is used for tracheal intubation with or without fibreoptic guidance and demonstrated the necessary time for successful tracheal intubation through Ambu aura gain .Hence this study is design to compare tracheal intubation with or without fibreoptic guidanceAIM:to evaluate ambu aura gain as a conduit for tracheal intubation with or without fibreoptic guidancePRIMARY IBJECTIVE: to evaluate the time taken for successful tracheal intubation with or without fibreoptic guidance.METHODOLOGY:in the operation theatre,standard monitors will be attached and routine conduct of general anaesthesia planned. Ambu aura gain will be inserted and depending on randomisation,tracheal intubation by endotracheal tube will be done either using fibreoptic or without fibreoptic guidance. OUTCOME MEASURES WILL INCLUDE:1)INTUBATION TIME: timed elapsed from disconnecting the ventiltor circuit on ambu aura gain till appearance of first normal capnogram with breathing circuit connected to ETT after placement in trachea.2.Number of attempts for insertion of ETT tube: An attempt will be defined as removal of ETT from
AAG after insertion in the trachea. Total number of attempts for ETT intubation will be 3
for each group and after that it will be marked as a failure.
3. First attempt success rate: The first attempt success rate of tracheal intubation
with or without fibre optic guidance through Ambu aura gain
will be measured.
4.Ease of ETT intubation: Grading of ease of intubation is according
to the intubation anaesthesiologist Grading
of ease of ETT intubation:
|
Grade 1
|
Very easy
|
|
Grade 2
|
Easy
|
|
Grade 3
|
Difficult
|
|
Grade 4
|
Very difficult
|
STATISTICAL
ANALYSIS:Unpaired
t test / Mann Whitney U test will be used to compare normally distribute or
non-normally distributed variables respectively. P <0.05 will be taken as
significant. Statistical analysis will be done by SPSS version 20.0
|