| CTRI Number |
CTRI/2014/07/004777 [Registered on: 25/07/2014] Trial Registered Retrospectively |
| Last Modified On: |
24/07/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the efficiency of two devices,Macintosh laryngoscope and C-Mac D-Blade videolaryngoscope for double lumen tube intubation in patients requiring one lung ventilation for surgery |
|
Scientific Title of Study
|
Comparison of the C-Mac D-blade videolaryngoscope and the Macintosh laryngoscope for double lumen tube intubation |
| Trial Acronym |
MACD-DLT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShagun Bhatia Shah |
| Designation |
Consultant Anaesthesiology |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
RAJIV GANDHI CANCER INSTITUTE AND RESEARCH CENTRE
SECTOR-5; ROHINI; DELHI-110085
Rajiv Gandhi Cancer Institute and Research Centre
Sector-5 ; Rohini ; New Delhi -110085
North West
DELHI
New Delhi- 110085.
India |
| Phone |
9891769779 |
| Fax |
|
| Email |
shah.shagun@rgcirc.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShagun Bhatia Shah |
| Designation |
Consultant Anaesthesiology |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Rajiv Gandhi Cancer Institute and Research Centre
Sector-5 ; Rohini ; New Delhi -110085
North West
DELHI
New Delhi- 110085.
India |
| Phone |
9891769779 |
| Fax |
|
| Email |
shah.shagun@rgcirc.org |
|
Details of Contact Person
Public Query
|
| Name |
DrShagun Bhatia Shah |
| Designation |
Consultant Anaesthesiology |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Rajiv Gandhi Cancer Institute and Research Centre
Sector-5 ; Rohini ; New Delhi -110085
North West
DELHI
New Delhi- 110085.
India |
| Phone |
9891769779 |
| Fax |
|
| Email |
shah.shagun@rgcirc.org |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Cancer Institute and research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Shagun Bhatia Shah |
| Address |
H.No-174-175; ground floor ;pocket -17; sector-24; rohini- Delhi-110085 |
| Type of Sponsor |
Other [being the Principal Investigator] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr AK Bhargava |
Rajiv gandhi cancer institute and research centre
Sector-5 Rohini Delhi-110085 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHAGUN BHATIA SHAH |
OPERATION THEATRE; THIRD FLOOR ;OLD BUILDING; RAJIV GANDHI CANCER INSTITUTE AND RESEARCH CENTRE |
RAJIV GANDHI CANCER INSTITUTE AND RESEARCH CENTRE; SECTOR-5 ;ROHINI; DELHI-110085
North West
DELHI |
9891769779
shah.shagun@rgcirc.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board Rajiv Gandhi Cancer Institute and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Double Lumen Tube placement in patients requiring Lung isolation for thoracic surgeries , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
C-MAC D-BLADE VIDEOLARYNGOSCOPE |
USE OF C-MAC D-BLADE VIDEOLARYNGOSCOPE FOR DOUBLE LUMEN TUBE INSERTION FOR LUNG ISOLATION |
| Comparator Agent |
Mc INTOSH LARYNGOSCOPE |
Mc INTOSH LARYNGOSCOPE USE FOR DOUBLE LUMEN TUBE INSERTION FOR LUNG ISOLATION |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1-2
Patients requiring a DLT for thoracic surgery
|
|
| ExclusionCriteria |
| Details |
Risk of regurgitation and pulmonary aspiration
Mouth opening < 1.5 cm
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Time required for intubation(in seconds)
• Incidence of complications -(Blood on device•Oral bleeding•Bronchospasm
•Arrhythmia•Hoarseness•DLT misplaced into wrong bronchus•DLT Cuff Damage)
|
N/A
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
HEMODYNAMIC CHANGES (HEART RATE,SBP,DBP,MAP)
|
1 MINUTE POST INTUBATION
3 MINUTES POST INTUBATION |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/05/2014 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective randomized, single blind, parallel group active control,single centric observational trial comparing the Macintosh laryngoscope and the C-MAC D-Blade videolaryngoscope for double lumen tube insertion in 60 consecutive patients requiring lung isolation for thoracic surgery. The primary outcome measures will be time in seconds required for DLT insertion and occurance of complications ( blood on device, oral bleeding,bronchospasm , arrhythmias, hoarseness,DLT cuff damage and DLT misplacement into wrong bronchus). The secondary outcome measures would be the hemodynamic changes( heart rate, systolic, diastolic and mean blood pressure)at 1 and 3 minutes post intubation |