| CTRI Number |
CTRI/2020/09/027523 [Registered on: 01/09/2020] Trial Registered Prospectively |
| Last Modified On: |
27/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [comparision of methods of intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the placement of a Second generation supra-glottic airway device using the introducer tool and stylet in a neutral head position in adults under general anaesthesia. |
|
Scientific Title of Study
|
Comparison of Proseal laryngeal mask airway (PLMA)placement using introducer tool and stylet in neutral head position in adult patients under general anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dasara Nongbet |
| Designation |
Post graduate student |
| Affiliation |
Atal Bihari Vajpayee Institute Of Medical Sciences and Dr.Ram Manohar Lohia. |
| Address |
House no-5,Upper Lansonalane,Jaiaw.
Opposite St.Joseph Dispensary,Shillong
East Khasi Hills
MEGHALAYA
793002
India |
| Phone |
7896847410 |
| Fax |
|
| Email |
dasara.nongbet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namita Arora |
| Designation |
Associate Professor |
| Affiliation |
Atal Bihari Vajpayee Institute Of Medical Sciences and Dr.Ram Manohar Lohia. |
| Address |
Atal Bihari Vajpayee Institute Of Medical Sciences and Dr.Ram Manohar Lohia.
New Delhi
DELHI
110001
India |
| Phone |
9868219619 |
| Fax |
|
| Email |
namitaarora16@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dasara Nongbet |
| Designation |
Post graduate student |
| Affiliation |
Atal Bihari Vajpayee Institute Of Medical Sciences and Dr.Ram Manohar Lohia. |
| Address |
House no-5,Upper Lansonalane,Jaiaw.
Opposite St.Joseph Dispensary,Shillong
East Khasi Hills
MEGHALAYA
793002
India |
| Phone |
7896847410 |
| Fax |
|
| Email |
dasara.nongbet@gmail.com |
|
|
Source of Monetary or Material Support
|
| Atal Bihari Vajpayee Institute Of Medical Sciences and DrRam Manohar Lohia Hospital |
|
|
Primary Sponsor
|
| Name |
Atal Bihari Vajpayee Institute Of Medical Sciences and DrRam Manohar Lohia |
| Address |
Baba Kharak Singh Road,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 Dasara Nongbet |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital |
Baba Kharak Singh Road
New Delhi
DELHI |
07896847410
dasara.nongbet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee,PGIMER,Dr.RML Hospital |
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 |
Proseal Laryngeal Mask Airway placement using an introducer tool |
To compare Proseal Laryngeal Mask Airway placement using an introducer tool in neutral head position. |
| Comparator Agent |
Proseal Laryngeal Mask airway placement with stylet. |
Proseal laryngeal mask airway placement with a stylet in neutral head position |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA status I and II.
Elective surgery under general aneasthesia using proseal laryngeal mask airway |
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway(Mallampati grade greater than equal to grade III,thyromental distnace less than 6cm.)
Mouth opening less than 2.5cm.
BMI greater than equal to 35kg/metre sqaure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Proseal laryngeal mask airway palcement using Brimacombe fibre-optic scoring system |
no post-op follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
First attempt success rate of Proseal laryngeal mask airway(PLMA) insertion.
Number of insertion attempts.
Total time to successful insertion.
Haaemodynamic response to insertion. |
no post-op follow up. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/09/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised comparative study comparing the Proseal Laryngeal mask airway (PLMA) placement using the Introducer tool and Stylet in neutral head position in 60 adults (30 patients in each group)under general anaesthesia.It will be conducted at Atal Bihari Vajpayee Institute of Medical Sciences and Dr.Ram Manohar Lohia Hospital,New Delhi,India. The primary outcome measures the placement of the PLMA using a scoring within 2 years. The secondary outcome will measure the first attempt success rate,number of insertion attempts,total time to successful insertion and the haemodynamic response to insertion within a period of 2 years. |