| CTRI Number |
CTRI/2021/12/038679 [Registered on: 16/12/2021] Trial Registered Prospectively |
| Last Modified On: |
15/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Observational study comparing the safety and efficacy of Igel Supraglottic airway device insertion in anaesthetised patients by Anesthesia faculty versus residents |
|
Scientific Title of Study
|
Observational study comparing the safety and efficacy of Igel Supraglottic airway device insertion in anaesthetised patients by Anesthesia faculty versus residents |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr BHAVINI SHAH |
| Designation |
Professor Anesthesiology |
| Affiliation |
Dr. D.Y. Patil Medical College and Hospital and Research Centre, Pimpri Pune |
| Address |
Department of Anesthesiology
Dr. D.Y. Patil Medical College and Hospital and Research
Centre,
Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipanjali Mahanta |
| Designation |
Resident Anesthesiology |
| Affiliation |
Dr. D.Y. Patil Medical College and Hospital and Research Centre, Pimpri Pune |
| Address |
Department of Anesthesiology
Dr. D.Y. Patil Medical College and Hospital and Research
Centre,
Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9673586122 |
| Fax |
|
| Email |
dipanjalimahanta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipanjali Mahanta |
| Designation |
Resident Anesthesiology |
| Affiliation |
Dr. D.Y. Patil Medical College and Hospital and Research Centre, Pimpri Pune |
| Address |
Department of Anesthesiology
Dr. D.Y. Patil Medical College and Hospital and Research
Centre,
Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9673586122 |
| Fax |
|
| Email |
dipanjalimahanta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology Dr D Y Patil Medical College Hospital and Research Centre Pune |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology |
| Address |
Dr. DY Patil Medical College Hospital and Research Centre Pune |
| 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 Dipanjali Mahanta |
Dr. D.Y Patil Medical College Hospital and Research Centre |
Department of Anesthesiology
Dr. D.Y Patil Medical College Hospital and Research Centre
Pune
MAHARASHTRA |
9673586122
dipanjalimahanta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| scientific committee |
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 |
I-Gel insertion by faculty |
15 minutes |
| Comparator Agent |
I-Gel insertion by residents |
15 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I-II fit patients.
2. Patients posted for elective surgery under GA requiring I-gel Supraglottic Airway device insertion.
3. Availability of informed consent and willingness of the patient to be a part of the study. |
|
| ExclusionCriteria |
| Details |
1. Patients belonging to ASA grade III-IV
2. Patients with cardiac, neurological and respiratory diseases.
3. Patients with full stomach.
4. Emergency case patients.
5. Patients scheduled for head and neck surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the haemodynamic parameters at the time of Igel insertion |
5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe any complications during and after the insertion.
|
20 minutes |
To compare the number of attempts taken for successful insertion of i-gel as well as the time taken to do so by each group.
|
5 minutes |
|
|
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)
|
14/01/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an observational study comparing the safety and efficacy of Igel supraglottic airway device in anaesthetised patients by Anesthesia faculty versus residents, to study ease of insertion and learning curve associated with Igel use. |