| CTRI Number |
CTRI/2018/11/016466 [Registered on: 28/11/2018] Trial Registered Prospectively |
| Last Modified On: |
27/11/2018 |
| 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 ILMA and AIR-Q for intubation using Parkers tube. |
|
Scientific Title of Study
|
A study to evaluate and compare Intubating Laryngeal Mask Airway and AIR-Q for 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 |
S K Singhal |
| Designation |
Senior Professor |
| Affiliation |
Pt.B.D.Sharma PGIMS (Rohtak) |
| Address |
Department of Anaesthesiology,Pt.B D Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416391115 |
| Fax |
|
| Email |
ssinghal12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Himani |
| Designation |
Post Graduate Student |
| Affiliation |
Pt.B.D.Sharma PGIMS Rohtak |
| Address |
Department Of Anaesthesia
PGIMS Rohtak
Pt.B.D.Sharma PGIMS Rohtak(Haryana)
Rohtak
HARYANA
124001
India |
| Phone |
9466526302 |
| Fax |
|
| Email |
drhimanimittal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Himani |
| Designation |
Post Graduate Student |
| Affiliation |
Pt.B.D.Sharma PGIMS Rohtak |
| Address |
Triveni Hostel
Room NO-52
PGIMS Rohtak
Pt.B.D.Sharma PGIMS Rohtak(Haryana)
Rohtak
HARYANA
124001
India |
| Phone |
9466526302 |
| Fax |
|
| Email |
drhimanimittal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hospital.Pt B D Sharma PGIMS Rohtak |
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesiology |
| Address |
Pt B D Sharma PGIMS,Rohtak |
| 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 Himani |
PGIMS |
Department Of Anaesthesiology,Pt.B D Sharma PGIMS Rohtak
Rohtak
HARYANA |
9466526302
ssingal12@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 |
| Comparator Agent |
Blind tracheal intubation |
Blind tracheal intubation through AIR-Q using Parker flex tip tube. |
| Intervention |
Blind tracheal intubationm |
Blind tracheal intubation through Intubating Laryngeal Mask Airway 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. |
|
| ExclusionCriteria |
| Details |
Patient having
1.Respiratory or pharyngeal pathology
2.Restricted mouth opening(less then 2.5cm)
3.Body mass index more then or equal to 35 kg/m2
4.Pregnancy
5.Suspected difficult airway |
|
|
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 Intubating Laryngeal Mask Airway versus AIR-Q using Parker flex tip tube. |
Once-at 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="110"
Sample Size from India="110"
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)
|
29/11/2018 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Airway management is a crucial skill for anaesthesiologist. Hence good practice and familiarity with variety of airway devices is essential for anaesthesiologist. In last few years a number of supraglottic devices have been introduced in clinical practice.These devices have changed the situation from ’unable to ventilate,unable to intubate’ to ’able to ventilate,able to intubate’.The Intubating Laryngeal Mask Airway(ILMA or LMA FASTRACH) was designed specifically to facilitate tracheal intubation while maintaining ventilation.The ILMA overcomes the diameter-length limitations for tracheal tube imposed by classic LMA and facilitates guidance of tracheal tube towards the glottis.A relatively new supraglottic airway device,the AIR-Q intubating laryngeal airway is an alternative to ILMA to facilitate endotracheal intubation. Flex tip Parker tube is non traumatic,less expensive and to the best of our knowledge there is no study comparing its use for intubation with ILMA and AIR-Q.So in this present study we plan to compare ILMA and AIR-Q for intubation using flex tip Parker tube.The study is a prospective randomised,single blinded,parallel group,single centre trial comparing the ILMA and AIR-Q for blind tracheal intubation using Parker flex tip tube in 110 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. |