| CTRI Number |
CTRI/2018/03/012563 [Registered on: 15/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
13/03/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two supraglottic devices in gynaecological surgeries |
|
Scientific Title of Study
|
A Comparative study of Baska mask and i-gel in patients undergoing Elective Gynaecological Surgery
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAnjeleena Kumar Gupta |
| Designation |
Senior Consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Department of Anaesthesia, Pain and Perioperative Medicine,
Sir Ganga Ram Hospital ,
New Delhi
Central
DELHI
110060
India |
| Phone |
9818422867 |
| Fax |
|
| Email |
anjeleenasgrh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnjeleena Kumar Gupta |
| Designation |
Senior Consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Department of Anaesthesia, Pain and Perioperative Medicine,
Sir Ganga Ram Hospital ,
New Delhi
Central
DELHI
110060
India |
| Phone |
9818422867 |
| Fax |
|
| Email |
anjeleenasgrh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAnjeleena Kumar Gupta |
| Designation |
Senior Consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Department of Anaesthesia, Pain and Perioperative Medicine,
Sir Ganga Ram Hospital ,
New Delhi
Central
DELHI
110060
India |
| Phone |
9818422867 |
| Fax |
|
| Email |
anjeleenasgrh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,
Sir Ganga Ram Hospital, New Delhi. 110060 |
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram Hospital |
| Address |
Department of Anaesthesia, Pain and Perioperative Medicine,
Sir Ganga Ram Hospital, New Delhi |
| 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 Anjeleena Gupta |
Sir Ganga Ram Hospital |
Department of Anaesthesia,
Sir Ganga Ram hospital
Old Rajender nagar
Central
DELHI |
9818422867
anjeleenasgrh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sir Ganga Ram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
In Patients undergoing elective gynecological surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Baska mask |
This study aims at comparing Baska mask with i-gel in terms of oropharyngeal seal pressure (OSP), duration of insertion, success rates of insertion, ease of insertion, pharyngolaryngeal morbidity and other adverse effects in elective gynaecological surgeries.
Total duration of study was 6 months.
Total duration of therapy- up to 4 hours postoperative |
| Comparator Agent |
i-gel |
This study aims at comparing Baska mask with i-gel in terms of oropharyngeal seal pressure (OSP), duration of insertion, success rates of insertion, ease of insertion, pharyngolaryngeal morbidity and other adverse effects in elective gynaecological surgeries.
Total duration of study was 6 months.
Total duration of therapy- up to 4 hours postoperative |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.ASA physical status I-III
2.Age ≥ 18 years
3.Fasting more than 6 hours
4.BMI ≤ 35 kg/m2
5.Surgery duration < 2 hours
|
|
| ExclusionCriteria |
| Details |
1.Refusal to consent
2.Patients with anticipated difficult airway
3.Risk of aspiration of gastric contents (Pregnancy, full stomach, hiatus hernia)
4.Surgery requiring tracheal intubation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare oropharyngeal seal pressure of the two devices |
postinduction, after recovery and 4 hours after anaesthesia recovery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Insertion time
2.Rate of first time successful placement of the devices
3.Number of attempts for insertion of device
4.Ease of insertion
5.Pharyngolaryngeal morbidity
6.Other adverse effects like dysphagia, sore throat
|
1.At the time of insertion
2.At the end of surgery
3.30 minutes post operative
4.Four hours post opertaive |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
11/01/2017 |
| Date of Study Completion (India) |
11/07/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare Baska mask with i-gel in terms of oropharyngeal seal pressure(OSP),duration
of insertion, success rates of insertion, ease of insertion, pharyngolaryngeal
morbidity and other adverse effects in elective gynaecological surgeries
lasting less than two hours.
|