| CTRI Number |
CTRI/2014/09/004961 [Registered on: 03/09/2014] Trial Registered Retrospectively |
| Last Modified On: |
02/09/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparision of influence of head and neck position on ventilation with two supraglottic airway devices (Proseal Laryngeal Mask Airway and I-gel) |
|
Scientific Title of Study
|
Comparision of influence of head and neck position on oropharyngeal leak pressures and cuff position with the Proseal Laryngeal Mask Airway and I-gel |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Nawaz |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
no 69 samadana road
priyadarshini nagar
605006
pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9585526343 |
| Fax |
|
| Email |
mnawaz123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandeep Kumar Mishra |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
C/o Departmnent Of Anaesthesiology
JIPMER, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9344668104 |
| Fax |
|
| Email |
jipmermishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammad Nawaz |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
no 69 samadana road
priyadarshini nagar
605006
pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9585526343 |
| Fax |
|
| Email |
mnawaz123@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
gorimedu pondicherry
605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mohammad Nawaz |
operation theatres 1 & 2, 5 & 6. Department Of Anaesthesiology and Critical Care, JIPMER |
Dhanvantari nagar, pondicherry 605006
Pondicherry
PONDICHERRY |
9585526243
mnawaz123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients who are undergoing elective surgeries under ASA 1 or ASA 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
change in position namely flexion, extension, lateral rotation |
the positions are changed with both the I-gel and proseal LMA in situ and the outcomes recorded |
| Comparator Agent |
sealing pressures, airway pressures, brimacombe score, EtCO2, oropharyngeal leak pressures in all positions recorded |
sealing pressures, airway pressures, brimacombe score, EtCO2, oropharyngeal leak pressures in all positions recorded with both devices in situ |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2 posted for elective surgeries |
|
| ExclusionCriteria |
| Details |
patients at risk for aspiration,
limited head and neck movements,COPD, asthma or difficult airway
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
oropharyngeal leak pressures
Peak airway pressures
delivered tidal volume |
before and after the change in head and neck position |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
cuff position
Airway morbidity |
scored by using flexible fibreoptic laryngoscope and Brimacome scoring after change in head and neck position compared with neutral.
any airway related morbidity recorded after the study, followed up and managed appropriately. Study done in short mostly day care cases hence no long term follow up done. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/06/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study was designed to assess and compare the effect of head and neck positions namely flexion, extension and lateral rotation on oropharyngeal leak pressures and cuff position with the proseal laryngeal mask airway and the I-gel; with the hypothesis that various head and neck positions affect ventilation and cuff position with these two supraglottic airway devices, |