| CTRI Number |
CTRI/2020/10/028480 [Registered on: 20/10/2020] Trial Registered Prospectively |
| Last Modified On: |
19/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
outcome assesor blinded |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation of lung ultrasound score with oxygenation in pneumonia |
|
Scientific Title of Study
|
Correlation of Lung Ultrasound aeration score with Oxygenation in Ventilator associated pneumonia (VAP) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAGARIKA PANDA |
| Designation |
SR Academic |
| Affiliation |
AIIMS RISHIKESH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
AIIMS RISHIKESH
VIRBHADRA MARG
RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
08280097212 |
| Fax |
|
| Email |
sp.ruby@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANKIT AGARWAL |
| Designation |
Additional Professor |
| Affiliation |
AIIMS RISHIKESH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
AIIMS RISHIKESH
VIRBHADRA MARG
RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
08475000280 |
| Fax |
|
| Email |
drankit80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANKIT AGARWAL |
| Designation |
Additional Prfessor |
| Affiliation |
AIIMS RISHIKESH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
AIIMS RISHIKESH
VIRBHADRA MARG
RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
08475000280 |
| Fax |
|
| Email |
drankit80@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY, AIIMS RISHIKESH, UTTARAKHAND |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Sagarika Panda |
AIIMS RISHIKESH |
CRITICAL CARE UNIT,
LEVEL 06
DEPARTMENT OF ANAESTHESIOLOGY
Dehradun
UTTARANCHAL |
08280097212
sp.ruby@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J189||Pneumonia, unspecified organism, (2) ICD-10 Condition: J189||Pneumonia, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Intervention |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient fulfilling the diagnosis criteria of VAP(as per Clinical Pulmonary Infection Score ) |
|
| ExclusionCriteria |
| Details |
1. Evidence of disseminated malignancy.
2. Pregnancy.
3. Thoracic dressings.
4. Subcutaneous emphysema.
5. Chronic obstructive pulmonary disease.
6. Interstitial lung disease.
7. Morbid obesity
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Correlation between Lung ultrasound aeration score and lung compliance
2.Correlation betwwen lung ultrasound aeration score and arterial oxygenation .
|
Started on suscipicion of Ventilator associated pneumonia as day 1 to be done for 5 days at 9 am in the morning |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Correlation between day 1 Lung ultrasound score and 28-day mortality
2. Correlation between day 1 Lung ultrasound score and duration of mechanical ventilation
|
Day 1 on inclusion into the study to Day 28 |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
11/11/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Ventilator associated pneumonia is one of the major cause of hospital acquired infection, which leads to increase ICU and hospital length of stay . There is no single gold standard test for its diagnosis and monitoring.Chest xray has less specificity in supine critically ill patient and CT scan expose the sick patients to transport out of ICU .Ultrasound is a simple , non invasive and raditaion free device for diagnosing consolidation in Ventilator associated peumonia patients , On suspicion of development of ventilator associted pneumonia ,lung ultrasound will be done to calculate lung aeration score , and at the same time artrial blood gas will be obtain to measure PaO2/FiO2 ratio and from inspiratory pause maneuver on ventilator static lung compliance will be measured .Patients will bve followed up for 28 days from the day of first inclusion into the study . |