| CTRI Number |
CTRI/2025/11/096979 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing ultrasound measurement of the cricoid catilage with the traditional method i.e height and sex of the patient for choosing the correct breathing double lumen tube size used during chest surgery |
|
Scientific Title of Study
|
A Randomised study to compare the accuracy of conventional method versus cricoid cartilage diameter measurement by ultrasonography for predicting the correct double lumen tube size at SMS 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. REEMA MEENA |
| Designation |
Senior professor |
| Affiliation |
SAWAI MAN SINGH MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anesthesiology , 2nd floor , Dhanwantri building , JLN Marg, Jaipur , Rajasthan
Jaipur
RAJASTHAN
302001
India |
| Phone |
9513237117 |
| Fax |
|
| Email |
reemadr.rn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
REEMA MEENA |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
sawai man singh medical college |
| Address |
Department of anaesthesiology, operation theatre,SMS MEDICAL COLLEGE AND HOSPITAL, JAIPUR RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413237117 |
| Fax |
|
| Email |
reemadr.rn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha Singh |
| Designation |
RESIDENT DOCTOR |
| Affiliation |
SMS medical college and hospital |
| Address |
Department of Anesthesiology, Operation theatre 2 , SMS medical college and hospital, Jaipur , Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
8824816689 |
| Fax |
|
| Email |
nehadr1897@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY, Sawai Man singh medical college and hospital, jaipur, rajasthan , 302004 |
|
|
Primary Sponsor
|
| Name |
SAWAI MAN SINGH MEDICAL COLLEGE AND HOSPITAL |
| Address |
SMS HOSPITAL , SAWAI MAN SINGH ROAD / JLN MARG, JAIPUR, RAJASTHAN |
| 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 |
| amit dubey |
sms jaipur |
sawai man singh medical college and hsopital , jaipur
Jaipur
RAJASTHAN |
9414984313
ethicscommitteesmsjaipur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SELECTING DOUBLE LUMEN TUBE DOUBLE LUMEN TUBE SIZE BASED ON CRICOID CARTILAGE DIAMETER MEASUREMENT BY USG. |
PATIENTS CRICOID CARTILAGE DIAMETER WILL BE TAKEN BY PLACING PROBE ON ANTERIOR NECK THEN PRECEEDING IN CAUDAL DIRECTION , CRICOID CARTILAGE AND VOCAL CORDS WERE VISUALISED. THE SUBGLOTTIC DIAMETER WAS MEASURED AT CRICOID CARTILAGE LEVEL DURING APNOEA. AS SECONDARY OBJECTIVE , LMB DIAMETER WILL BE MEASURED BY CT AND TUBE WILLE BE SELECTED BY SAME. |
| Comparator Agent |
TAKING DOUBLE LUMEN TUBE BY CONVENTIONAL METHOD USING HEIGHT AND SEX |
DOUBLE LUMEN TUBE SIZE MEASUREMENT ON BASIS OF HEAIGHT AND SEX AS A CONVENTIONAL METHOD |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient aged between 18 to 60 years of either sex.
2.American society of anaesthesiologist [ASA] grade class I-III patient
3.Patient requiring one lung ventilation with double lumen tube for thoracotomy |
|
| ExclusionCriteria |
| Details |
1. Anticipated difficult airway.
2. poor ultrasound image of cricoid cartilage
3. Patient taking part in any other study
4. History of tracheostomy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess and compare two methods for predicting correct double lumen tube size |
time taken for correct placement of tube and intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine the difference in number of intubation attempt needed in between 2 groups
2. To compare correct size of double lumen tube selected on basis of two methods.
3. To assess & compare complications and incidence of intubation related injuries in between two groups |
1.Mean time taken for intubation
2. Mean no of intubation attempt
3.Mean score of quality of lung collapse
4. mean difficulty assessment score
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
16/11/2025 |
| 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="6"
Days="0" |
|
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
|
Double lumen tube is most commonly used device to provide lung isolation in thoracic, mediastinal and vascular surgeries. DLTs isolate lung anatomically and physically. Dlts are available in different sizes because an optimal size is important for optimal positioning. DLT size can be selected according to sex, height but this method lead to selection of inappropriate DLT. There is no uniform standard method for selecting double lumen tube. Imaging such as USG and CT can provide a better measurement. Selection of appropriate double lumen tube is important as if significantly reduces complications associated with an oversized or undersized double lumen tube for effective lung isolation and ventilation during surgery. Patient is taken in OT. NBM status , PAC written and informed consent will be checked. Patient demographic data are taken like age , sex , BMI, NIBP. Routine vital monitors are attached for ECG, SpO2, Etco2, Entropy , peripheral IV lines. After randomization patients will be allocated in two groups. Baseline characterstics are noted such as HR , SBP, DBP, MBP {INVASIVE}. In one group DLT selection will be done on basis of conventional method and in other group selection is done on basis of cricoid diameter by ultasonography . Variables will be noted such as mean intubation time , no of attempts , time taken for correct placement of tube , difficulty assessment score . Post operative complications such as sore throat ,dysphagia and hoarseness of voice is also assessed Stastical analysis is done using appropriate software and conclusions are drawn |