| CTRI Number |
CTRI/2021/04/032611 [Registered on: 07/04/2021] Trial Registered Prospectively |
| Last Modified On: |
07/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Oropharyngeal leak pressure of LMA Protector Vs LMA Proseal in different head and neck positions |
|
Scientific Title of Study
|
Comparison of oropharyngeal leak pressure of LMA Protector with ProSeal LMA in different head and neck positions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUKHYANTI KERAI |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology & Intensive Care
Room no-413 BL Taneja block
Maulana Azad Medical College
Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI
1100002
India |
| Phone |
09968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUKHYANTI KERAI |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Intensive Care
413 BL Taneja Block
Maulana Azad Medical College
Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI
1100002
India |
| Phone |
09968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUKHYANTI KERAI |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Intensive Care
413 BL Taneja Block
Maulana Azad Medical College
Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI
1100002
India |
| Phone |
09968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Bhadur Shah Zafar Marg, New Delhi-110002 |
| 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 |
| Sukhyanti Kerai |
Lok Nayak Hospital and associated trauma centre |
Operation theater block( first, second and third floor)Operation theater in gynaecology building
Operation theatres in trauma centre (first floor)
Department of Anaesthesilolgy
Central
DELHI |
9968527122
drsukhi25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LMA Proseal |
oropharyngeal seal pressure of LMA Proseal in neutral head position to extended and flexed head positions |
| Intervention |
LMA Protector |
oropharyngeal seal pressure of LMA Protector in neutral head position to extended and flexed head positions will be measured |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age>18 years
ASA physical status I & II
Anticipated duration of surgery≤ 2 hours
|
|
| ExclusionCriteria |
| Details |
Known or predicted difficult airway
-Patients with pre-existing cervical spine pathology (neck pain or tenderness in cervical spines or associated paraesthesia in upper limbs)
-BMI > 35kg/m2
-Thorax, major upper abdomen, Head & neck surgeries
-Surgeries requiring lateral or prone positioning
-Patient at risk of aspiration such as pregnant patients, those with inadequate fasting, hiatal hernia, gastric outlet obstruction
-Mouth opening less than 3 centimetres
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| oropharyngeal leak pressures of LMA protector and PLMA in different head and neck positions |
after insertion of devices |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| number of attempts for successful insertion of devices |
after insertion of devices |
| time taken for successful insertion of devices |
during insertion of devices |
| ease of placement of devices |
after placement of devices |
| ease of placement of nasogastric tubes through devices |
after placement of devices |
| presence of blood on the cuff of devices |
when the device is taken out from patients during extubation |
| postoperative sore throat |
1, 2 and 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
12/04/2021 |
| 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="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)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsukhi25@gmail.com].
- For how long will this data be available start date provided 01-07-2021 and end date provided 01-12-2023?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The oropharyngeal leak pressure is marker of efficacy of supraglottic devices. As the pharyngeal anatomy changes accroding to different head and neck position, the performance of supraglottic device may be affected.Proseal LMA is considered criterion standard supraglottic device and its superiority has been established in terms of better oropharyngeal leak pressure over LMA Classic, LMA Supreme and i gel.Previous studies have suggested that it can be utilized regardless of head and neck position. We will be comparing oropharyngeal leak pressures of LMA Protector, a new supraglottic device and LMA Proseal in 70 patients scheduled for elective surgeries. Standrad protocol for preanaesthetic surgery will be followed and consent for participation in trial will be taken.On the day of surgery , general anaesthesia will be induced in standard manner. Based on computer generated random table patients will be allocated to one of the two groups; in one group LMA protector will be used and in another LMA Proseal . The primary outcome of study will be comparison of oropharyngeal leak pressure of two devices in neutral, flexion, extension and lateral rotation of head and neck. Number of attempts for sucessful insertion, ease of insertion,laryngeal view on fibreoptic bronchoscopy, ease of insertion of nasogastric tube,, presence of blood on cuff of device after extubation and postoperative sore throat. |