| CTRI Number |
CTRI/2020/08/027143 [Registered on: 14/08/2020] Trial Registered Retrospectively |
| Last Modified On: |
31/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
supraglottic airway devices |
|
Scientific Title of Study
|
Comparison of three different supraglottic airway devices in prone position- A manikin based randomized study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Babita Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute of medical sciences, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine & Critical Care, JPNATC division,
Room no 124, First Floor, JPNATC, All India Institute of Medical Sciences (AIIMS), New Delhi-110029, India
New Delhi
DELHI
110029
India |
| Phone |
09868397815 |
| Fax |
|
| Email |
drbabitagupta@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Babita Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute of medical sciences, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine & Critical Care, JPNATC division,
Room no 124, First Floor, JPNATC, All India Institute of Medical Sciences (AIIMS), New Delhi-110029, India
New Delhi
DELHI
110029
India |
| Phone |
09868397815 |
| Fax |
|
| Email |
drbabitagupta@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Babita Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute of medical sciences, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine & Critical Care, JPNATC division,
Room no 124, First Floor, JPNATC, All India Institute of Medical Sciences (AIIMS), New Delhi-110029, India
New Delhi
DELHI
110029
India |
| Phone |
09868397815 |
| Fax |
|
| Email |
drbabitagupta@hotmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences , New Delhi-110029, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences (AIIMS),New Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Babita Gupta |
JPNATC, AIIMS |
Department of Anesthesia and Orthopaedics of Jai Prakash Narayan Apex Trauma Center of the All India Institute of Medical Sciences, New Delhi.
New Delhi
DELHI
New Delhi
DELHI |
9868397815
drbabitagupta@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
There are no patients involved. The study would be done on a manikin (Laerdal airwayamanagement trainer).
50 Senior Residents will participate in the study.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
supraglottic airway devices management |
Comparison of three different supraglottic airway devices was done.IGel, CLMA and PLMA was performed by 40 residents on manikin and median time taken for insertion was 25 sec, 17 sec, and 12 secs respectivelya |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
All the senior residents of Department of Anaesthesiology, who have successfully inserted all three supraglottic airway device in atleast 50 patients |
|
| ExclusionCriteria |
| Details |
Senior residents who have not inserted any of the three supraglottic airway devices in atleast 50 patients will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the most appropriate device for securing aaaaairway in prone position during accidental extubation aaaain terms of
• Ease of insertion
|
Till the point of supraglottic airways device insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time taken to secure airway
2. Ease of ventilation |
Till the point of supraglottic airways device insertion |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2014 |
| Date of Study Completion (India) |
15/10/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Airways management is the most important step in anaesthesia practice. Many surgical procedures are performed in prone position and accidental extubation poses extremely difficult and challenging scenario to maintain a patient airways. In such situations, conventionally the patients is turned supine and managed accordingly or attempted to intubate in prone position. However, turning the patient supine from prone position is time consuming and with 3-pin traction oe a stereotactic frame the situation becomes more difficult.
Hence , this study has been proposed to find an alternative way to secure airway in prone position in emergency situation.
|