| CTRI Number |
CTRI/2020/08/027326 [Registered on: 24/08/2020] Trial Registered Prospectively |
| Last Modified On: |
13/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of ultrasonography, clinical methods and capnography for detecting endotracheal tube placement in intensive care unit |
|
Scientific Title of Study
|
Comparison of ultrasonography, clinical methods and capnography for detecting endotracheal tube placement in intensive care unit: an observational study at SMS Hospital Jaipur during 2019-2021 |
| Trial Acronym |
|
|
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 GOVERNMENT HOSPITAL |
| Address |
Department of Anaesthesia, second floor, Dhanvantri Block (near OT-1 complex), Sms medical college and attached hospital, jaipur
Jaipur
RAJASTHAN
302007
India |
| Phone |
9413237117 |
| Fax |
|
| Email |
reemadrrn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reema Meena |
| Designation |
Senior Professor |
| Affiliation |
SAWAI MAN SINGH GOVERNMENT HOSPITAL |
| Address |
Depart of Anaesthesia, second floor, Dhanvantri block (near OT1 complex) Sms medical college and attached hospital, jaipur
Jaipur
RAJASTHAN
302007
India |
| Phone |
9413237117 |
| Fax |
|
| Email |
reemadrrn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purbali Singharoy |
| Designation |
Junior Resident |
| Affiliation |
SMS HOSPITAL |
| Address |
Department of Anaesthesia, Second floor, near ot 1 complex, Dhanvantri Bhawan,, SMS HOSPITAL,JAIPUR
Jaipur
RAJASTHAN
302007
India |
| Phone |
704219170 |
| Fax |
|
| Email |
drpurbalisingharoy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, 2nd floor Dhanvantri block, SMS medical college |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF ANAESTHESIA |
| Address |
Department of Anaesthesia , second floor, Dhanvantri block, SMS hospital
Jaipur, 302007
302007 |
| 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 Reema Meena |
SMS Medical College and Hospital,Jaipur |
Department of Anaesthesiology,
Second floor, Dhanwatri bhawan,
Sms Medical College and Hospital
Jaipur
Rajasthan
302007
Jaipur
RAJASTHAN |
9413237117
reemadrrn@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: J962||Acute and chronic respiratory failure, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring intubation in ICU
Patients of either sex
Patient between the age group of 20 to 65 years |
|
| ExclusionCriteria |
| Details |
Patients in whom ultrasonography of neck cannot be conducted for example neck tumor, neck masses, goitre.
Patients with anatomical neck distortion.
Patients with history of pneumectomy , pleurodesis, difficult intubation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine sensitivity, specificity, positive predictive value, negative predictive value of ultrasonography and classical clinical method against gold standard end tidal carbon dioxide to detect tube placement |
Within seconds when each methods will be confirming endotracheal tube placed or not |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine difference in time taken to detect tube placement by ultrasonography, classical clinical methods and capnography. |
Time taken by each method to detect ETT placement |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
27/08/2020 |
| 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="8"
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
|
In this study we want to compare the accuracy and speed of ultrasonography method is with respect to clinical method and capnography for determining endrotracheal tube (ETT) placement. |