| CTRI Number |
CTRI/2019/04/018839 [Registered on: 30/04/2019] Trial Registered Prospectively |
| Last Modified On: |
28/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A research to evaluate and compare two medical devices(Proseal laryngeal mask airway and Gnana laryngeal airway II) use to ventilate the patients undergoing elective surgery under general anesthesia. |
|
Scientific Title of Study
|
Comparative evaluation of Proseal laryngeal mask airway with Gnana laryngeal airway II in paralysed patients undergoing elective surgery with controlled ventilation. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohit Garg |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical college and Hospital, Sector 32, Chandigarh. |
| Address |
Department of Anaesthesia and Intensive care, Government Medical college and Hospital, Sector 32, Chandigarh.
Chandigarh
CHANDIGARH
160031
India |
| Phone |
7888446085 |
| Fax |
|
| Email |
gargsmohit003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJasveer Singh |
| Designation |
Associate Professor |
| Affiliation |
Government Medical college and Hospital, Sector 32, Chandigarh. |
| Address |
Department of Anaesthesia and Intensive care, Government Medical college and Hospital, Sector 32, Chandigarh.
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9646121664 |
| Fax |
|
| Email |
drjassy18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJasveer Singh |
| Designation |
Associate Professor |
| Affiliation |
Government Medical college and Hospital, Sector 32, Chandigarh. |
| Address |
Department of Anaesthesia and Intensive care, Government Medical college and Hospital, Sector 32, Chandigarh.
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9646121664 |
| Fax |
|
| Email |
drjassy18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical college & Hospital, Sector 32, Chandigarh.pin code 160031,india |
|
|
Primary Sponsor
|
| Name |
Government Medical college Hospital Sector Chandigarh |
| Address |
Department of Anaesthesia &Intensive care, Government Medical college & Hospital, Sector 32, Chandigarh. |
| 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 |
| Mohit Garg |
operation theatre |
Department of anaestheisa and intensive care,block D ,level 5,chandigarh
Chandigarh
CHANDIGARH |
7888446085
gargsmohit003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics commitee(GMCH Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All participants will either be ASA(American Society of Anaesthesiologists)grade 1 or 2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gnana LA II |
will be used to maintain the patency of airway during general anaesthesia.will be inserted only once after induction of anaesthesia. |
| Comparator Agent |
Proseal Laryngeal Mask(PLMA) |
will be used to maintain the patency of airway during general anaesthesia.will be inserted only once after induction of anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group between 18 to 60 years
2. American Society of Anaesthesiologist (ASA) physical status I and II.
3. Patients scheduled for elective surgery under general anaesthesia (Duration of surgery 2 ± 0.5 hrs) |
|
| ExclusionCriteria |
| Details |
1. Patients with anticipated difficult airway (Airway Difficulty Score>8).22
2. Patients with upper respiratory tract infection
3. Patients with increased risk of regurgitation and aspiration of gastric content
4. Patients with a body mass index (BMI) > 35 kg.m.-2
5. Patients with past history of radiotherapy to the neck involving the hypopharynx
6. Patients undergoing surgeries involving neck and oral cavity
7. Pregnant patients. |
|
|
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 |
| 1.To compare the oropharyngeak leak pressure ofProSeal laryngeal mask airway with Gnana laryngeal airway II in paralysed patients undergoing elective surgery with controlled ventilation . |
immediately after the placement of device. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2.To evaluate the efficacy of ProSeal laryngeal mask airway with Gnana laryngeal airway II for
device insertion success,
ease of gastric tube placement,
fibreoptic visualization of glottis,
hemodynamic,ventilatory parameters,
amount of oropharyngeal secretions sucked and side effects if any. |
1.Ease of insertion,fiberoptic visualization-will be observed immediately after placement of device.
2.Haemodynamic and ventilatory parameters-at 1,2,3,4,5 and 10 minutes |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2019 |
| 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
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is prospective,randomized,parallel group,active control trial where two devices Gnana LA II and Proseal laryngeal mask airway will be used for maintainence of airway during general anesthesia.These devices will be compared primarily in terms of oropharyngeal leak pressure(OLP),which signifies the efficacy of seal offered around laryngeal outlet.Secondary outcome measures will compare the overall efficacy of Gnana LA II and Proseal laryngeal mask airway by comparing the ease of insertion,fiberoptic visualization,hemodynamic and ventilatory parameters in paralysed patients undergoing elective surgery with controlled ventilation. |