| 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
|
|
|
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
|
|
|
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. |