| CTRI Number |
CTRI/2018/12/016682 [Registered on: 14/12/2018] Trial Registered Prospectively |
| Last Modified On: |
13/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study To Compare two supraglottic devices for blind intubation |
|
Scientific Title of Study
|
A Study To Compare Air-Q Intubating Laryngeal Airway With Ambu AuraGain Laryngeal Mask For Blind tracheal Intubation Using Parker Flex Tip Tube. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jatin lal |
| Designation |
Professor |
| Affiliation |
Pt B D Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology, Pt B D Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
|
| Fax |
|
| Email |
dr.jatinlal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jatin lal |
| Designation |
Professor |
| Affiliation |
Pt B D Sharma PGIMS Rohtak |
| Address |
Room No 6 Department of anaesthesiology, PGIMS rohtak
Rohtak
HARYANA
124001
India |
| Phone |
|
| Fax |
|
| Email |
Dr.jatinlal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Somesh |
| Designation |
Junior Resident |
| Affiliation |
Pt B D Sharma PGIMS Rohtak |
| Address |
Room no 3, Doctor hostel pgims rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9992907320 |
| Fax |
|
| Email |
someshritwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, PGIMS, Rohtak,pin code 124001 |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology |
| Address |
Pt B D Sharma PGIMS,
Rohtak |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| nil |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Somesh |
Pt B.D Sharma PGIMS rohtak |
Department of Anaesthesiology, Pt B D Sharma PGIMS Rohtak
Rohtak
HARYANA |
9992907320
someshritwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pt B D Sharma PGIMS/UHS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
undergoing elective surgery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blind tracheal Intubation |
Blind tracheal intubation through Air-Q using parker flex tip tube. |
| Comparator Agent |
Blind tracheal intubation |
Blind tracheal intubation through Ambu Auragain using parker flex tip tube. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients belonging to American Society of Anaesthesiologists
(ASA) physical status I or II scheduled for elective surgery under general anaesthesia
requiring endotracheal intubation will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients having
1.Respiratory or pharyngeal pathology
2.Restricted mouth Opening(<2.5cm)
3.Body mass index (>35kg/m2)
4.Gastroesophageal reflux disease, upper GIT surgery or pathology
5.Surgery in position other than supine
will be excluded from study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Success rate of blind tracheal intubation through Air-Q intubating laryngeal airway versus Ambu AuraGain laryngeal mask using Parker flex tip tube. |
Once - At the time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts, Ease and insertion time for intubation |
Once - at time of intubation |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
20/12/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Airway management is crucial skill for clinical anaesthesiologist. Hence good practice and familiarity with variety of airway devices and techniques is essential. SGADs were introduced in clinical practice with intervention of laryngeal mask airway (LMA) by Dr. AIJ Brain in 1981. Ambu AuraGain is a 3rd third generation supraglottic airway device which may have intubation capability. Since there is only one study available in literature by Sethi et al comparing Ambu AuraGain and Air Q ILA for blind tracheal intubation so we plan to further evaluate these two devices for blind tracheal intubation using Parker Flex Tip tube.The study is a prospective randomised, single blinded, parallel group, single centre trial comparing the Air Q intubating laryngeal airway with Ambu AuraGain laryngeal mask for blind tracheal intubation using parker flex tip tube in 120 patients of ASA grade 1 or 2 undergoing elective surgical procedure under general anaesthesia at Pt B D Sharma PGIMS Rohtak. The primary outcome measure will be success rate of blind tracheal intubation
|