| CTRI Number |
CTRI/2019/05/018929 [Registered on: 03/05/2019] Trial Registered Prospectively |
| Last Modified On: |
02/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing I-gel versus LMA Proseal regarding airway management in controlled hypertensive patients. |
|
Scientific Title of Study
|
Comparative assessment of I-gel and LMA Proseal for airway management in controlled hypertensive patients posted for short surgical procedures. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrTanuka Mandal |
| Designation |
Post graduate trainee |
| Affiliation |
North Bengal Medical College |
| Address |
North Bengal Medical College,
Department of Anaesthesiology
Darjiling
WEST BENGAL
734012
India |
| Phone |
9474389169 |
| Fax |
|
| Email |
tanuka4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanmay Sarkar |
| Designation |
RMO |
| Affiliation |
North Bengal Medical College |
| Address |
North Bengal Medical College
Department of Anaesthesiology
Darjiling
WEST BENGAL
734012
India |
| Phone |
08016939433 |
| Fax |
|
| Email |
dr.sarkar08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanmay Sarkar |
| Designation |
RMO |
| Affiliation |
North Bengal Medical College |
| Address |
North Bengal Medical College
Department of Anaesthesiology
Darjiling
WEST BENGAL
734012
India |
| Phone |
08016939433 |
| Fax |
|
| Email |
dr.sarkar08@gmail.com |
|
|
Source of Monetary or Material Support
|
| North Bengal Medical College and Hospital
P.O: Sushrutnagar
Dist: Darjeeling
Pin:734012 |
|
|
Primary Sponsor
|
| Name |
Tanuka Mandal |
| Address |
Qtr no. B/10 North Bengal Medical College, Sushrutnagar, Darjeeling |
| Type of Sponsor |
Other [Self] |
|
|
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 Tanmay Sarkar |
North Bengal Medical College |
Department of Anaesthesiology
Sushrutnagar
Darjeeling
Darjiling
WEST BENGAL |
08016939433
dr.sarkar08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| North Bengal Medical College Institutional Ethics Committee |
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 |
| Intervention |
I-gel |
Supra-glottic airway device (Second generation)
Oral route
Duration: less than 45mins |
| Comparator Agent |
LMA Proseal |
Supra-glottic airway device (Second generation)
Oral route
Duration: Less than 45mins |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.MPG I&II
2.Mouth opening >2.5cm
3.Controlled hypertensives (BP≤140/90mm of Hg with medication). |
|
| ExclusionCriteria |
| Details |
1.Restricted mouth opening (≤2.5cm)
2.Risks of aspiration( GERD, hiatus hernia)
3.Oropharyngeal pathology, cervical spine fracture or instability
4.History of known or anticipated difficult airway. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Insertion time (in secs) |
Time recorded from which the predetermined sized lubricated SAD was picked up to the time it was correctly placed with first effective end-tidal capnography waveform was seen |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of attempts for insertion
|
1/2/failed |
| Ease of insertion |
Easy/Difficult |
| Fibreoptic assessment of airway tube on a four point scale |
Brimacombe scoreïƒ 4:only vocal cords are visible, 3: cords and posterior epiglottis visible, 2: cords and anterior epiglottis visible, 1: vocal cords not seen |
| Hemodynamic responses |
MAP/HR |
| Oropharyngeal leak pressure |
cm of H2O |
| Post-operative complications |
Airway trauma
Sore throat |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/05/2019 |
| 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="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)?
|
|
Brief Summary
|
This study will mainly focus on comparing i-gel with LMA proseal regarding their airway management and pressor response in controlled hypertensive patients. Ethical clearance has been taken for this prospective,randomised, single blinded comparative trial that will be conducted in the Anaesthesiology dept of North Bengal Medical College and Hospital. Sixty patients of either sex, aged 20-60yrs, MPG I-II, controlled hypertensive will be included in the study after proper counselling and obtaining informed consent. Patients with anticipated difficult airway, risk of aspiration, recent history of sore throat and lung co-morbidity will be excluded from the study. Randomisation will be done by computer generated code in sequentially numbered sealed envelope. Study variables will include insertion time as primary outcome and others like number of insertion attempts, ease of insertion, fibre-optic grading of larynx, oro-pharyngeal leak pressure, hemodynamic responses (mean arterial pressure/ heart rate) before and after 1 min, 2min, 3min, and 5min post insertion of supraglottic airway device. Post-operative blood staining , sore-throat and dysphagia will also be studied. |