| CTRI Number |
CTRI/2020/03/024044 [Registered on: 18/03/2020] Trial Registered Prospectively |
| Last Modified On: |
30/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
use of ultrasound to measure thickness of diaphragm and amplitude of diaphramatic movement in patients on mechanical ventilator to make patient free from mechanical ventilation as early as possible |
|
Scientific Title of Study
|
Ultrasound guided diaphragmatic excursion
derived parameters for successful prediction
of weaning inpatients receiving mechanical ventilation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Umang sharma |
| Designation |
Post graduate student |
| Affiliation |
Government medical college and hospital sector 32 chandigarh |
| Address |
Department Of Anaesthesia Level V , Block D GMCH Chandigarh
Chandigarh
CHANDIGARH
160032
India
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9724925337 |
| Fax |
|
| Email |
coolumang21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Richa Saroa |
| Designation |
Associate Professor |
| Affiliation |
Government medical college and hospital sector 32 chandigarh |
| Address |
Department Of Anaesthesia Level V , Block D GMCH Chandigarh
1208, Sector 32 B Chandigarh
Chandigarh
CHANDIGARH
160032
India
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9646121513 |
| Fax |
|
| Email |
richajayant@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umang sharma |
| Designation |
Post graduate student |
| Affiliation |
Government medical college and hospital sector 32 chandigarh |
| Address |
Department Of Anaesthesia Level V , Block D GMCH Chandigarh
Chandigarh
CHANDIGARH
160032
India
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9724925337 |
| Fax |
|
| Email |
coolumang21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and intensive care, level V ,block D,Government Medical College and Hospital, Chandigarh sec. 32 |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh |
| Address |
Government Medical College and Hospital, sector 32B Chandigarh,
160032
Chandigarh
|
| 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 Umang sharma |
Government college and hospital chandigarh, sector- 32 |
Department of Anaesthesia and intensive care, level V,block D, GMCH sec. 32
Chandigarh
CHANDIGARH |
9724925337
coolumang21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee (GMCH ,Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided measurement of diaphragm thickness and diaphragmatic movement |
Diaphragm ultrasound will be performed using high frequency linear array probe and low frequency curvilinear probe (3.5- 5 MHz). The probe will be placed in the right subcostal margin between the mid clavicular and anterior axillary line, parallel to the excursion of the diaphragm. 2 D(B mode) will be used to search the line of right hemidiaphragm. The diaphragmatic excursions will be measured in M mode from baseline to point of maximum height of inspiration at the zone of apposition of diaphragm and rib cage. Diaphragm thickness will be measured in the zone of apposition of the diaphragm and rib cage in the mid axillary line between the eighth and tenth intercostal space by placing the curvilinear probe allowing placement of M mode line parallel to the excursion of the diaphragm. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients with age 18 yrs or more, having received mechanical ventilation, in process of weaning from the same will be included in the proposed study |
|
| ExclusionCriteria |
| Details |
1. Patients aged less than 18 years
2. Received mechanical ventilation for less than 24 hrs,
3. Preexisting diaphragm disease
4. Any breach in skin preventing DUS examination in subcostal area
5. Phrenic nerve palsy
6. Refusal of consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the efficacy of ultrasound guided diaphragmatic movement derived parameters in predicting weaning from ventilator in patients receiving mechanical ventilation in ICU. |
gap of 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare and evaluate diaphragmatic movement derived parameters with ventilator derived parameters as a guide to the weaning process.
2.Correlation of diaphragmatic movement derived parameters with duration of weaning
|
gap of 12 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/04/2020 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this study is randomised, prospective
this study is to measure the efficacy of ultrasound guided diaphragmatic movement derived parameters in predicting weaning from ventilator in patients receiving mechanical ventilation in icu
|