| CTRI Number |
CTRI/2012/04/002585 [Registered on: 18/04/2012] Trial Registered Retrospectively |
| Last Modified On: |
29/12/2011 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
a clinical trial to compare three aids for endotracheal intubation, ILMA, C-Trach, and Cobra PLA in patients in whome cervical spine injury has been simulated. |
|
Scientific Title of Study
|
endotracheal intubation with ILMA, C-Trach(TM) and Cobra PLA (TM) in simulated cervical spine injury patients-a comparative study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rashmi Ramachandran |
| Designation |
Associate Professor |
| Affiliation |
AIIMS |
| Address |
Department of Anaesthesia
All India Institute of Medical Sciences
Ansari Nagar, Delhi
INDIA
New Delhi
DELHI
110029
India |
| Phone |
011-26594606 |
| Fax |
|
| Email |
rashmiramachandran1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr rashmi ramachandran |
| Designation |
associate professor |
| Affiliation |
AIIMS |
| Address |
Department of Anaesthesia
All India Institute of Medical Sciences
Ansari Nagar
Delhi
New Delhi
DELHI
110029
India |
| Phone |
011-26594607 |
| Fax |
|
| Email |
rashmiramachandran1@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr deepak mathew |
| Designation |
Junior resident |
| Affiliation |
AIIMS |
| Address |
Department of Anaesthesia
All India Institute of Medical Sciences
Ansari Nagar
Delhi
New Delhi
DELHI
110029
India |
| Phone |
011-26594606 |
| Fax |
|
| Email |
deepakgregory@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, Delhi
110029 |
| 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 |
| dr rashmi ramachandran |
All India Institute of Medical Sciences |
Room # 5013, Department of Anaesthesia, AIIMS, Ansari Nagar,-110029
New Delhi
DELHI |
011-26593212
rashmiramachandran1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethics committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Healthy patients scheduled for elective surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
C-trach laryngeal mask airway (C-Trach) TM |
Supraglottic airway device with inbuilt optical fibres to provide real time view of glottis and the process if endotracheal tube entering the glottis when a dedicated screen is attached. |
| Comparator Agent |
Cobra perilaryngeal airway (Cobra PLA) |
Supraglottic airway device used both for ventilation and as aid to endotracheal intubation under fibreoptic guidance |
| Intervention |
Intubating Laryngeal Mask Airway (ILMA) |
Supraglottic airway device used as a conduit for endotracheal intubation especially in patients with difficult airway |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1,2 patients posted for surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
difficult airway, full stomach patients,patients who refuse consents |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ability to intubate patients with different aids |
not applicable |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| success rate of intubation, hemodynamic changes, complications during use, postoperative morbidity |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/10/2009 |
| 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="6"
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 is a randomized comparative study to see the success rate of intubation with different intubating aids. ASA1 and 2 patients will be selected. Cervical collar will be applied to simulate cervical spine trauma. General anaesthesia will be induced and endotracheal intubation done with the help of different aids |