| CTRI Number |
CTRI/2019/10/021623 [Registered on: 14/10/2019] Trial Registered Prospectively |
| Last Modified On: |
15/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of success rates between two devices called AIR Q and LMA Blockbuster which are used to pass a tube into the wind pipe and secure the airway as well as ensure normal breathing in patients taken for surgery and undergoing general anesthesia |
|
Scientific Title of Study
|
Comparison of blind tracheal intubation through Air-Q AND LMA Blockbuster in adults undergoing elective surgery: A RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
|
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Secondary IDs if Any
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavitha Girish |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology and Critical Care, 5th floor, Teaching block, AIIMS,
New Delhi- 110029.
New Delhi
DELHI
110029
India |
| Phone |
9500817025 |
| Fax |
|
| Email |
kavithagirish94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thilaka Muthiah |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS |
| Address |
Department of Anaesthesiology and Critical Care, 5th floor, Teaching block, AIIMS,
New Delhi- 110029.
New Delhi
DELHI
110029
India |
| Phone |
9940505695 |
| Fax |
|
| Email |
thilaks84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavitha Girish |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology and Critical Care, 5th floor, Teaching block, AIIMS,
New Delhi- 110029.
New Delhi
DELHI
110029
India |
| Phone |
9500817025 |
| Fax |
|
| Email |
kavithagirish94@gmail.com |
|
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Source of Monetary or Material Support
|
| Department of Anesthesiology, Pain Medicine and Critical Care All India Institute of Medical Sciences Ansari nagar New Delhi - 110029 |
|
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Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical Care, 5th floor, Teaching block, AIIMS,
New Delhi- 110029. |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kavitha Girish |
All India Institute of Medical Sciences |
Room No 5011, Teaching block, Department of Anesthesiology, Pain medicine and Critical Care,All India Institute of Medical Sciences Ansari nagar New Delhi – 110029 New Delhi DELHI
New Delhi
DELHI |
9500817025
kavithagirish94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for post graduate research, AIIMS |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A- Air Q |
Air Q will be used for securing the airway and as a conduit to intubation |
| Intervention |
Group B- LMA Blockbuster |
LMA Blockbuster will be used for securing the airway and as a conduit to intubation |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA I& II
Patients undergoing elective surgery under general anaesthesia requiring tracheal intubation
Weight < 90kg, BMI < 30kg/m2
|
|
| ExclusionCriteria |
| Details |
• Patient refusal to participate in the study.
• Respiratory or pharyngeal pathology.
• Patients with cervical spine disease.
• Potential difficult airway
• Risk of regurgitation
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Number of attempts to successful intubation through SGA. |
Time for placement of sga
Time for intubation through sga
Time for SGA removal
Vitals(HR, NIBP, SPO2, eTCO2) at baseline,2mins,4mins,6mins, 8mins,10mins,15mins,25mins, 35mins,45mins, 55mins,65mins,75mins,85mins,95mins,105mins,115mins,125mins.
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Number of attempts to successful placement of SGA
Insertion time of the study device
Insertion time of the tracheal tube
The time needed to remove the supraglottic airway from the pharynx
Glottic view under fibreoptic guidance
An adverse airway event
Incidence of sore throat post operatively
|
Intraoperative time plus post operative follow up for 24 hours |
|
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Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/10/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study is a randomized controlled parallel group study comparing the success rates of blind intubation using AIR-Q and LMA Blockbuster. Both are intubating supraglottic devices but to the best of our knowledge success rates of the two havent been compared. |