| CTRI Number |
CTRI/2018/05/013923 [Registered on: 16/05/2018] Trial Registered Prospectively |
| Last Modified On: |
14/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of intubating LMA Proseal, I-Gel and Baska mask. |
|
Scientific Title of Study
|
To compare the airway dynamics in patients undergoing laparoscopic cholecystectomy under general anesthesia with controlled ventilation using Proseal LMA, I-gel and Baska mask. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Brijender |
| Designation |
Junior resident |
| Affiliation |
Dr. RPGMC Kangra at Tanda |
| Address |
Junior resident. Deptt. of Anesthesia Dr.RPGMC Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9816330400 |
| Fax |
|
| Email |
drbijender577@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shelly Rana |
| Designation |
Professor |
| Affiliation |
Dr. RPGMC Kangra at Tanda |
| Address |
Department of Anesthesia Dr.RPGMC Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418113786 |
| Fax |
|
| Email |
shelkbj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Brijender |
| Designation |
Junior resident |
| Affiliation |
Dr. RPGMC Kangra at Tanda |
| Address |
Junior resident. Deptt. of Anesthesia Dr.RPGMC Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9816330400 |
| Fax |
|
| Email |
drbijender577@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deptt. of Anesthesia Dr.RPGMC Kangra at Tanda |
|
|
Primary Sponsor
|
| Name |
Deptt of Anesthesia DrRPGMC Kangra |
| Address |
Deptt. of Anesthesia. Dr. RPGMC Kangra at Tanda |
| 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 Brijender |
Dr.RPGMC Kangra at Tanda |
Dept. of Anesthesia.SSB Block IIId Floor. Dr.RPGMC Kangra at Tanda
Kangra
HIMACHAL PRADESH |
9816330400
drbijender577@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.Rajendra Prasad Government Medical College (Dr.RPGMC) Kangra at Tanda,Himachal Pradesh,India-176001. Institutional Ethics Committee [IEC] Registration No.ECR/490/Inst/HP/2013 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients will be of age 18 to 60 years and will be ASA I-II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
airway management with proseal LMA,Igel and Baska mask in patients under GA |
Study will be conducted for period of 18 months in 90 patients of both sex planned for laparoscopic cholecystectomy and airway dynamics will be compared by using proseal lma, i-gel and baska mask |
| Comparator Agent |
Group P:intubation using Proseal LMA
Group I: Intubation using I gel
Group B: Intubation will be done using Baska Mask |
In all patients we will compare airway dynamics and hemodynamics , ease of insertion and attempts in all three groups |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between the age group 18-60 years
2.ASA class I-II
3.BMI 18.5-29.9
4.Mallampati I or II |
|
| ExclusionCriteria |
| Details |
1.Mallampati III or IV
2.ASA III-IV
3.Failure to insert supraglottic airway device
4.BMI >35
5.Pregnancy
6.Full stomach and gastritis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the airway dynamics |
Study will be conducted over a period of 18 months in 90 patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare oropharyngeal leak pressure and cuff positions
2.To compare ease of insertion and number of attempts
3.Hemodynamics parameters
4.To look for blood on device on withdrawal and sore throat |
study will be conducted over a period of 18 months in 90 patients |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
28/05/2018 |
| 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="1"
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)?
|
|
Brief Summary
|
The study will be conducted at the Deptt. of Anesthesia Dr. RPGMC Kangra at Tanda. The objective of study is to compare the airway dynamics in patients udergoing laparoscopic cholecystectomy under general anesthesia using Proseal LMA, I-Gel and Baska Mask.The study will include 90 patients and will be divided in to 3 groups .The duration of study will be 18 months. |