| CTRI Number |
CTRI/2017/08/009534 [Registered on: 29/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
28/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of three commonly used supraglottic devices for their efficacy |
|
Scientific Title of Study
|
A comparative evaluation of proseal laryngeal mask airway,I-gel and supreme laryngeal mask airway in anesthetised paralysed adult patients undergoing elective surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anisha singh |
| Designation |
postgraduate student |
| Affiliation |
maulana azad medical college |
| Address |
Department of anesthesia
maulana azad medical college
new delhi
219 lnrdh hostel
mulana azad medical college
Central
DELHI
110001
India |
| Phone |
9810341603 |
| Fax |
09810341603 |
| Email |
Mamc.anesthesia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anju bhalotra |
| Designation |
professor |
| Affiliation |
maulana azad medical college |
| Address |
Department of anesthesia
maulana azad medical college
new delhi
House no 55, pocket g, Sarita Vihar, new delhi
Central
DELHI
110001
India |
| Phone |
09968604219 |
| Fax |
|
| Email |
drakgk@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Anisha singh |
| Designation |
postgraduate student |
| Affiliation |
maulana azad medical college |
| Address |
Department of anesthesia
maulana azad medical college
new delhi
219 lnrdh hostel
mulana azad medical college
Central
DELHI
110001
India |
| Phone |
9810341603 |
| Fax |
09810341603 |
| Email |
Mamc.anesthesia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department og anesthesia, maulana azad medical college, new delhi |
|
|
Primary Sponsor
|
| Name |
Department of anesthesia |
| Address |
Maulana azad medical college & lok nayak hospital
new delhi |
| 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 |
| Anisha Singh |
Maulana Azad medical college |
department of anesthesia
Central
DELHI |
9810341603
9810341603
anisha_sngh@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
undergoing elective surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 OR 2 |
|
| ExclusionCriteria |
| Details |
Known or predicted difficult airway ,full stomach or increased risk of aspiration (GERD, pregnancy, hiatus hernia) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal leak pressure |
1 min, 15 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time of insertion,ease of insertion, hemodynamic response and morbidity associated |
till 30 min of surgery |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2013 |
| Date of Study Completion (India) |
01/12/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
13. Brimacombe J, Keller C. The Proseal laryngeal mask airway: a randomised, crossover study with the standard laryngeal mask airway in paralysed, anesthetized patients. Anaesthesilogy.2009; 93: 104-9.
14. Richez B, Saltel L, Banchereau F, Torrielli R, Cros AM. A new single use supraglottic airway device with a noninflatable cuff and an esophageal vent: An observational study of the I-gel. Anesth Analg. 2008; 106:1137–9.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Our study was conducted to compare proseal laryngeal mask airway, I-gel and supreme laryngeal mask airway. All three devices were easy to insert,had 100% 1st attempt success rate,elicited similar hemodynamic response and allowed easy passage of nasogastric tube. Proseal LMA provided highest oropharyngeal leak pressure ( 32.64 cmH2O ), LMA Supreme provided higher oropharyngeal leak pressure compared to i-gel. I-gel And Supreme LMA were quick to insert (13.50 sec and 14.50 sec.All three devices are reliable airway devices,producing efficient airway leak pressures with a very low incidence of trauma and airway morbidity,no incidence of regurgitation and aspiration in any of the patients.
|