FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/067119 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 08/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison of various factors such as height and gender with dimensions of windpipe in selecting the size of tube used for securing the airway in lung surgery. 
Scientific Title of Study   A prospective comparative observational study of selection of appropriate sized double lumen tubes for one lung ventilation by conventional method of height and gender versus CT guided tracheobronchial measurements. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anisha Joy 
Designation  PG Registrar 
Affiliation  Christian Medical College Vellore 
Address  Department of Anaesthesia, CMC Vellore
LIQ Room 942, CMC Vellore
Vellore
TAMIL NADU
632004
India 
Phone  9655090656  
Fax    
Email  anishajoy14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Balaji K 
Designation  Professor 
Affiliation  Christian Medical College Vellore 
Address  Department of Anaesthesia, CMC Vellore
CMC Hospital, Town campus, Vellore
Vellore
TAMIL NADU
632004
India 
Phone  7406777127  
Fax    
Email  balooswamy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anisha Joy 
Designation  PG Registrar 
Affiliation  Christian Medical College Vellore 
Address  Department of Anaesthesia, CMC Vellore
LIQ Room 942, CMC Vellore
Vellore
TAMIL NADU
632004
India 
Phone  9655090656  
Fax    
Email  anishajoy14@gmail.com  
 
Source of Monetary or Material Support  
Fluid research Grant, Christian Medical College, Vellore, Tamil Nadu 632004, India 
 
Primary Sponsor  
Name  Anisha Joy 
Address  Department of Anaesthesia. CMC Vellore, Vellore, Tamil Nadu, PIN - 632004 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anisha Joy  Christian Medical College Vellore  Department of Anaesthesia, Christian Medical College Vellore, Tamil Nadu 632004,India
Vellore
TAMIL NADU 
9655090656

anishajoy14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board and Ethics Committee of CMC Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J96-J99||Other diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CT guided measurements  Measurements of tracheobronchial tree at different areas, like tracheal diameter, cricoid diameter, left main bronchus diameter using 3D Computed Tomography preoperatively. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  ASA I, ASA II and stable ASA III patients. 
 
ExclusionCriteria 
Details  Patient refusal
Age below 18 years
Unstable ASA III , ASA IV and above
Patients with distorted trachea and/or bronchial tree
Anticipated difficult airway
Patients having absolute contraindication for left sided DLT
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Patients requiring different size DLT for adequate lung isolation, as compared to the DLT size predicted by the conventional method of height and gender, for one lung ventilation.

 
one time measurement after securing airway, at 30min  
 
Secondary Outcome  
Outcome  TimePoints 
To calculate percentage of agreement of size of DLT with CT guided measurements like tracheal diameter , cricoid diameter & left main bronchus diameter.  One time measurement after securing airway at 30 mins 
To tabulate appropriate sized left DLT that can be used for different transverse diameter of cricoid  After 6 months 
To accurately measure & tabulate dimensions of different sizes of Left Double lumen tubes used regularly in operation room ,as a guide.  At baseline 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Surgeries requiring opening of chest cavity, might require, ventilation of only one lung, and other lung to be collapsed so that the surgery can be carried out easily. This is called one lung isolation/ventilation. This is also required in surgeries of one side lung. To achieve one lung ventilation, a specialised tube called Double lumen tube (DLT) is used. This tube is bigger in size as compared to a normal endotracheal tube used for ventilation during anaesthesia. Also, knowledge about exact size of the DLT is important as an undersized or oversized DLT can cause multiple problems. Oversized DLT can cause, trauma to the structures of windpipe, rupture of windpipe, not ventilating one lobe of the lung that needs to be ventilated and injury to teeth, tongue etc. An undersized DLT can cause dislodgement of tube after intubation, inadequate isolation of one lung, soiling of healthy lung etc.

                                   There are no standard formulas for calculating the size of DLT. Conventionally size of DLT is calculated based on patient demographics like height, weight and gender. However, studies have shown that this is not the right size for more than 50 percentage of cases. Preoperative CT scan provides measurements of trachea and bronchus which can be used to estimate size of appropriate DLT. This study aim to compare the two methods of selection of DLT.

 

 
Close