| CTRI Number |
CTRI/2024/01/061111 [Registered on: 04/01/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of ultrasonography in effectively decreasing ventilator support in ICU in tertiary hospital. |
|
Scientific Title of Study
|
Identification of effective weaning through diaphragmatic ultrasound added to clinical parameters among mechanically ventilated patients in ICU at tertiary care centre: A Prospective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayush Kumar Pandey |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University Of Medical Sciences, Saifai, Etawah. |
| Address |
Room No. 329,Department of Anaesthesiology and Critical Care, Uttar Pradesh University Of Medical Sciences, Saifai, Etawah.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8191044971 |
| Fax |
|
| Email |
ayushpandey2611@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Bahadur Singh |
| Designation |
Associate Professor |
| Affiliation |
Uttar Pradesh University Of Medical Sciences, Saifai, Etawah. |
| Address |
Room No. 329, Department of Anaesthesiology and Critical Care, Uttar Pradesh University Of Medical Sciences, Saifai, Etawah.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8191044971 |
| Fax |
|
| Email |
drrakeshsingh27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayush Kumar Pandey |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University Of Medical Sciences, Saifai, Etawah. |
| Address |
Room No. 329, Department of Anaesthesiology and Critical Care, Uttar Pradesh University Of Medical Sciences, Saifai, Etawah.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8191044971 |
| Fax |
|
| Email |
ayushpandey2611@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University Of Medical Sciences, Saifai, Etawah. Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University Of Medical Sciences, Saifai, Etawah. Uttar Pradesh |
| Address |
Uttar Pradesh University Of Medical Sciences, Saifai, Etawah. Uttar Pradesh. 206130 |
| 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 |
| Ayush Kumar Pandey |
Uttar Pradesh University Of Medical Sciences, Saifai, Etawah, Uttar Pradesh. |
UPUMS, Saifai, Etawah. Uttar Pradesh. 206130
Etawah
UTTAR PRADESH |
8191044971
ayushpandey2611@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Uttar Pradesh University of Medical Sciences Saifai, Etawah (U.P.)-206130 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K750||Abscess of liver, (2) ICD-10 Condition: K859||Acute pancreatitis, unspecified, (3) ICD-10 Condition: J952||Acute pulmonary insufficiency following nonthoracic surgery, (4) ICD-10 Condition: D126||Benign neoplasm of colon, unspecified, (5) ICD-10 Condition: G936||Cerebral edema, (6) ICD-10 Condition: N996||Intraoperative hemorrhage and hematoma of a genitourinary system organ or structure complicating a procedure, (7) ICD-10 Condition: K566||Other and unspecified intestinal obstruction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are healthy before the disease onset who are mechanically ventilated for more than 72 hours and with satisfactory clinical weaning parameters and have readiness for weaning from mechanical ventilation. |
|
| ExclusionCriteria |
| Details |
1. Patients with neuromuscular disorders.
2. Patients with pre existing diaphragmatic palsy.
3. Tracheostomised patients.
4. Patients undergone thoracic surgeries.
5. Patients with pneumothorax.
6. Poor image quality of ultrasound.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diaphragmatic thickness fraction. |
From 72 hours after intubation till extubation from mechanical ventilation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rapid shallow breathing index. |
After spontaneous breathing trial till extubation from mechanical ventilation. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/01/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ayushpandey2611@gmail.com].
- For how long will this data be available start date provided 01-07-2025 and end date provided 30-06-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Ultrasonography provides simple
non invasive method of quantifying diaphragmatic movements. Imaging diaphragm
with ultrasound can be done by measuring diaphragm thickening fraction (DTF). Diaphragmatic parameters determined by bedside ultrasonography can predict
weaning outcome with better performance than conventional parameters. The primary objective is to determine the diagnostic accuracy
of diaphragm thickening fraction (DTF) in predicting weaning success. After spontaneous breathing trial, rapid shallow
breathing index (RSBI) will be calculated. The thickness of the diaphragm at maximum
inspiration (TDmax) and maximum expiration (TDmin) will
measured as the Diaphragm Thickening Fraction (DTF). |