| CTRI Number |
CTRI/2020/09/027542 [Registered on: 02/09/2020] Trial Registered Prospectively |
| Last Modified On: |
01/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trail to study the comparison of Proseal Laryngeal Mask Airway versus Endotracheai Tube for Ventilatory Efficacy and Airway Dynamics in Patients Undergoing Beating-Heart Coronary Artery Bypass Grafting. |
|
Scientific Title of Study
|
Comparison of Proseal Laryngeal Mask Airway versus Endotracheal Tube for ventilatory Efficacy and Airway Dynamics in patients Undergoing Beating-Heart Coronary Artery Bypass Grafting in SMS Hospital Jaipur During 2019-2021. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Reema Meena |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
Department of Anaesthesiology,SMS Medical College,Jaipur |
| Address |
Department of Anaesthesiology,2nd floor,Dhanwantari building,SMS Medical College,Jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413237117 |
| Fax |
|
| Email |
reemadrrn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR REEMA MEENA |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
Department of Anaesthesiology,SMS Medical College,Jaipur |
| Address |
Department of Anaesthesiology,2nd floor,Dhanwantari building,SMS Medical College,Jaipur.
RAJASTHAN
302004
India |
| Phone |
9413237117 |
| Fax |
|
| Email |
reemadrrn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S Bhaskar |
| Designation |
PG Student |
| Affiliation |
Department of Anaesthesiology,SMS Medical College,Jaipur. |
| Address |
Department of Anaesthesiology,2nd floor,Dhanwantari building,SMS Medical College,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9490905277 |
| Fax |
|
| Email |
sorakayalabhaskar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,2nd floor,Dhanwantari building,SMS Medical College,Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology SMS Medical CollegeJaipur |
| Address |
JLN Marg,Jaipur(RAJASTHAN) 302004 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Reema Meena |
SMS Medical College,Jaipur |
Department of Anaesthesiology,SMS Medical College,JLN Marg,JAIPUR
Jaipur
RAJASTHAN |
9413237117
reemadrrn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endo Tracheal Tube |
30 patients are intubated with Endotracheal Tube then ventilatory efficacy and airway dynamics are noted at different time intervals |
| Comparator Agent |
NA |
NA |
| Intervention |
Proseal Laryngeal Mask Airway |
30 patients are intubated with Proseal Laryngeal Mask airway then ventilatory efficacy and airway dynamics are noted at different time intervals |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to give written informed consent. 2.Patients with ASA grade II and III 3.Patients of either sex 4.Age groups 40-60 years 5.Weighing 50 to 80 KGS 6.BMI :Less than 40Kg/M.Square |
|
| ExclusionCriteria |
| Details |
1.Anticipated difficult intubation/LMA insertion (inadequate mouth opening,cervical spine injury,oropharyngeal pathology) 2.Obese patients(BMI more than 35),COPD patients,Sleep apnea patients 3.Patients having allergy to anaesthetic drugs used in the study 4.REDO and Emergency surgeries |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare peak airway pressure and airway resistance in both groups |
Data will be recorded just before induction,1min,3min,5min,15min after induction of device and for every 15min till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To determine haemodynamic parameters in both groups 2.To evaluate difference in tidal volume and compliance in both groups 3.To evaluate oxygen saturation and end tidal CO2 4.To evaluate side effects if any |
Data will be recorded just before induction,1min,3min,5min,15min after insertion of device and for every 15min till the end of the surgery |
|
|
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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study we aim to compare ventilatory efficacy and airway dynamics in patients intubated with proseal laryngeal mask airwa.y and endotracheal tube undergoing beating-heart coronary bypass grafting |