| CTRI Number |
CTRI/2023/09/057585 [Registered on: 13/09/2023] Trial Registered Prospectively |
| Last Modified On: |
13/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To compare the accuracy of auscultation method versus lung ultrasound technique of positioning of Double Lumen Tube in patient undergoing cardio thoracic surgeries, which one is better? |
|
Scientific Title of Study
|
Comparison of auscultation method versus lung ultrasound technique to evaluate the accuracy of positioning of double lumen tube in patient undergoing cardio-thoracic surgery- a prospective observational and cross- sectional study in department of Anesthesia, at S.M.S. medical College, jaipur. |
| 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 Indu Verma |
| Designation |
Senior professor |
| Affiliation |
SMS medical College |
| Address |
Department of Anesthesia
SMS medical College
JLN Marg
Jaipur, Rajasthan.
Department of Anesthesia
SMS medical College
JLN Marg
Jaipur, Rajasthan.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9413622967 |
| Fax |
|
| Email |
dr.induverma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indu Verma |
| Designation |
Senior professor |
| Affiliation |
SMS medical College |
| Address |
Department of Anesthesia
SMS medical College
JLN Marg
Jaipur, Rajasthan.
Department of Anesthesia
SMS medical College
JLN Marg
Jaipur, Rajasthan.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9413622967 |
| Fax |
|
| Email |
dr.induverma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Agarwal |
| Designation |
PG resident |
| Affiliation |
SMS medical College |
| Address |
SMS PG hostel
SMS medical College
JLN Marg
Jaipur, Rajasthan.
Department of Anesthesia
SMS medical College
JLN Marg
Jaipur, Rajasthan.
Jaipur
RAJASTHAN
302004
India |
| Phone |
8302023018 |
| Fax |
|
| Email |
gargswati441@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology
Second floor, Dhanvantari complex, SMS medical College, jaipur |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical College and Hospitals |
| Address |
Department of anesthesiology
Second floor, Dhanvantari complex, SMS medical College, jaipur |
| Type of Sponsor |
Government medical college |
|
|
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 Indu Verma |
SMS medical college and hospital |
Department of anesthesiology
Second floor, Dhanvantari complex, SMS medical College, jaipur
Jaipur
RAJASTHAN |
9413622967
dr.induverma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sms medical college ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to give written and informed consent.
Age >18 years.
Patient undergoing Cardio Thoracic Surgery.
ASA Grade - II and III.
|
|
| ExclusionCriteria |
| Details |
Patient with a previous history of thoracic surgery.
Tracheostomised patient.
Patient diagnosed with Pleural effusion or Empyema, pneumothorax, having past history of pleurodesis.
ASA Grade- IV.
Patient with deranged Pulmonary Function test (anyone out of forced expiratory volume in 1 sec, total lung capacity, forced vital capacity <50% of predicted values). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess & compare the accuracy of positioning of Double Lumen Tube by auscultation method versus lung ultrasound technique in patient undergoing Cardio thoracic surgery during general anaesthesia. |
30 min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine Number of patients were position of tube is correct & Number of patient who required repositioning of tube & Evaluation time in confirming position between auscultation and ultrasonography |
40 minutes |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
30/09/2023 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Our aim is to compare auscultation method versus lung ultrasound technique to evaluate the accuracy of positioning of double lumen tube in patients undergoing cardio-thoracic surgery. |