| CTRI Number |
CTRI/2024/02/063180 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Size selection of double lumen tube in Indians |
|
Scientific Title of Study
|
double lumen tube for lung isolation in Indian population:applicability of size prediction based on internationally derived formulas |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Joona P |
| Designation |
Assistant Professor |
| Affiliation |
Malabar cancer center |
| Address |
Department of oncoanaesthesiology, Malabar cancer centre, Moozhikkara P.O, Thalassery
Kannur
KERALA
670103
India |
| Phone |
09496651604 |
| Fax |
|
| Email |
drjoonap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joona P |
| Designation |
Assistant Professor |
| Affiliation |
Malabar cancer center |
| Address |
Department of oncoanaesthesiology, Malabar cancer centre, Moozhikkara P.O, Thalassery
Kannur
KERALA
670103
India |
| Phone |
09496651604 |
| Fax |
|
| Email |
drjoonap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Joona P |
| Designation |
Assistant Professor |
| Affiliation |
Malabar cancer center |
| Address |
Department of oncoanaesthesiology, Malabar cancer centre, Moozhikkara P.O, Thalassery
Kannur
KERALA
670103
India |
| Phone |
09496651604 |
| Fax |
|
| Email |
drjoonap@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Malabar cancer center |
| Address |
Moozhikkara P.O, Kodiyeri, Thalassery, Kannur, Kerala, 670103 |
| 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 Joona P |
Malabar cancer centre |
Department of oncoanaesthesiology, Moozhikkara P.O,Kodiyeri, Thalassery, Kannur, Kerala, 670103
Kannur
KERALA |
09496651604
drjoonap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee malabar cancer center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. patients undergoing elective surgery requiring one lung ventilation and isolation wiyh left sided double lumen tube
2. ct thorax done as a part of routine workup |
|
| ExclusionCriteria |
| Details |
1. documented difficult airway
2. mediastinal mass causing distorsion of airway |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the correlation of size of double lumen tube in patients undergoing major oncosurgery in our centre with size predicted based on the internationally accepted recommendations |
Correlation will be assessed during the intraoperative period itself |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find out airway complications of double lumen tube insertion |
from december 2023 to may 2024 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
currently size of double lumen tube is calculated based on patients height or left main brochial diameter and the formulas are based on western population. our study want to assess to what extend thsese formulas are applicable in indian setting |