| CTRI Number |
CTRI/2022/10/046439 [Registered on: 13/10/2022] Trial Registered Prospectively |
| Last Modified On: |
11/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Study to compare the oro-pharyngeal leak pressure in different head and neck positions with LMA Protector Airway. |
|
Scientific Title of Study
|
A Study to compare the oro-pharyngeal leak pressure in different head and neck positions with LMA Protector Airway. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Susheela Taxak |
| Designation |
Senior professor PGIMS,Rohtak |
| Affiliation |
Pt.B.D.Sharma institute, PGIMS. |
| Address |
Department of Anaesthesiology and critical care Pt.B.D.Sharma ,PGIMS,Rohtak Haryana .
Department of Anaesthesiology and critical care PGIMS,ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9896067416 |
| Fax |
|
| Email |
susheelataxak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravipati Prafulla |
| Designation |
Postgraduate student PGIMS,Rohtak |
| Affiliation |
Junior resident |
| Address |
Department of Anaesthesiology and critical care Pt.B.D.Sharma institute of medical sciences Rohtak .
Department of Anaesthesiology and critical care Pt.B.D.Sharma institue of medical sciences Rohtak.
Rohtak
HARYANA
124001
India |
| Phone |
7981336623 |
| Fax |
|
| Email |
prafulla.anaesthesia07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ravipati Prafulla |
| Designation |
Postgraduate student PGIMS,Rohtak |
| Affiliation |
Junior resident |
| Address |
Department of Anaesthesiology and critical care Pt.B.D.Sharma institute of medical sciences Rohtak .
Department of Anaesthesiology and critical care Pt.B.D.Sharma institute of medical sciences Rohtak.
Rohtak
HARYANA
124001
India |
| Phone |
7981336623 |
| Fax |
|
| Email |
prafulla.anaesthesia07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical care PT.B.D.Sharma PGIMS Rohtak. |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Pt B D Sharma PGIMS Rohtak |
| 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 |
| DrPrafulla |
Pt.B.D.Sharma PGIMS ,Rohtak |
Department of Anaesthesiology ,PT.B.D.Sharma ,PGIMS Rohtak,Haryana
Rohtak
HARYANA |
7981336623
prafulla.anaesthesia07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Reasearch Ethics Committee ,PT.B.D.Sharma PGIMS,Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
To compare the oro-pharyngeal leak pressure in different head and neck positions with LMA Protector Airway. |
A study compare the oro-pharyngeal leak pressure in different head and neck positions with LMA Protector Airway device.That is comparing in neutral postion with right lateral ,left lateral,flexion and extension of head and neck posstions |
| Intervention |
To compare the oro-pharyngeal leak pressure in different head and neck postions with LMA Protector Airway |
To compare oro-pharyngeal leak pressure between neutral,flexion,extension,right lateral,left lateral postions with LMA Protector Airway.
In Duration of 2months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group 18-70 years of either sex having ASA I&II and MPG I&II with weight 50 -70kgs scheduled for surgery under general anaesthesia will be included in the study |
|
| ExclusionCriteria |
| Details |
1. Patients who do not give consent
2. Difficult Airway
3. Patient at risk of pulmonary aspiration
4. Inadequate fasting
5. cervical spine disorders
6. Mouth opening <3cm
7. Morbid obesity (BMI >30kg/m2)
8. Patients with loose dentures
9. MPG >2
10. Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare the differance in oro pharyngeal leak pressure with change of head and neck positions using LMA Protector Airway device |
The outcome will be estimated at baseline,4 weeks and 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of insertion of LMA Protector Airway Device |
Number of attempts
Hemodynamic variations at neutral,flexion,extension,right lateraland left lateral postions are noted
Fiber-optic grading in neutral position
Immediate Post-operative complications ,after 30minutes and after one hour will be noted if any
Immediate post operative
30mins after
And one hour after study |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
17/10/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Supraglottic airway devices are increasingly being used for various surgeries ,some of which may also involve intra operative movement of head and neck position.it is important to see whether the LMA Protector airway device is maintaining an adequate seal with change in position ,So we propose to compare the oro-pharyngeal leak pressure in different head and neck positions with LMA Protector device. |