| CTRI Number |
CTRI/2024/08/072496 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the role of airway parameters with ultrasound scanning based respiratory measurements in predicting and overcoming breathing machine(ventilator) support in seriously ill patients in ICU |
|
Scientific Title of Study
|
Comparison of airway occlusion pressure with ultrasound based respiratory indices to predict weaning in critically ill patients 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 |
Lahareesh B L |
| Designation |
Senior Resident, DM Critical Care Medicine |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 5013, 5th floor, Teaching block, Department of
Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9112082723 |
| Fax |
|
| Email |
lahareeshbl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyotsna Punj |
| Designation |
Professor, Department of Anaesthesiology, Pain Medicine and Critical Care |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 5016, 5th floor, Teaching block, Department of
Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810191116 |
| Fax |
|
| Email |
jyotsna_punj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Lahareesh B L |
| Designation |
Senior Resident, DM Critical Care Medicine |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 5013, 5th floor, Teaching block, Department of
Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9112082723 |
| Fax |
|
| Email |
lahareeshbl@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari East, New Delhi, Pin 110029, INDIA |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
Sri Aurobindo Marg, Ansari Nagar East, New Delhi, Pin code 110029, INDIA
|
| 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 |
| Dr Lahareesh B L |
ALL INDIA INSTITITUTE OF MEDICAL SCIENCES |
AB8 ICU, 8TH FLOOR,
WARD BLOCK, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS
New Delhi
DELHI |
9112082723
lahareeshbl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee, AIIMS, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults(age ≥ 18 years)
2.Mechanically ventilated for ≥ 48 hours due to medical or surgical reasons
3.Eligible for a SBT as decided by the intensivist, according to ACCP/ATS/ERS guidelines
|
|
| ExclusionCriteria |
| Details |
1.Neuromuscular disorders affecting respiratory muscles
2.Contraindications for ultrasound examination (e.g., chest wounds, subcutaneous emphysema)
3.Refusal to participate in the study
4.Pregnancy
5.Morbid obesity
6.Neuromuscular blocking agents within 48 hours preceding diaphragm function assessment
7.Pneumothorax, pneumomediastinum, flail chest, or rib fractures
8.Patients primarily ventilated due to cardiac failure
9.Patients with diaphragmatic paralysis/injury on admission
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the area under the receiver operating characteristic curves(AUROCs) of airway occlusion pressure (P0.1), parasternal intercostal muscle thickening fraction/Diaphragm thickening fraction ratio (PMTF/DTF), and Diaphragm thickening fraction/Rapid shallow breathing index ratio (DTF/RSBI) to predict weaning outcome in critically ill mechanically ventilated patients. |
48 hours after Mechanical ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare P0.1, PMTF/DTF ratio, and DTF/RSBI ratios on subsequent spontaneous breathing trials (SBTs)
2.To correlate PMTF and DTF on the day of discharge from the intensive care unit (ICU) with the number of days of mechanical ventilation and length of stay (LOS) in the ICU.
|
48 hours after Mechanical ventilation till discharge from ICU |
|
|
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)
|
15/09/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The purpose of this study is to assess the usefulness of various ultrasound based respiratory indices with respiratory drive parameter in better predicting weaning of critically ill patients from mechanical ventilation. Patients are generally intubated and placed on mechanical ventilator when their own ventilatory and/or gas exchange capabilities are outstripped by the demands placed on them from a variety of diseases. As the conditions that warranted placing the patient on the ventilator stabilize and begin to resolve, attention is directed towards discontinuing the mechanical ventilation as quickly as possible. This process is termed “ventilator weaningâ€. The process allows patients to resume spontaneous breathing after a gradual reduction in ventilatory support and ultimately helps liberate them from mechanical ventilation. Current guidelines suggest several bedside indices to predict successful weaning and extubation. However, none of these indexes have been proven to be optimal in predicting weaning success. Careful clinical assessments are required to determine the patient’s readiness for weaning and subsequent discontinuation of ventilatory support and, ultimately, successful extubation. To facilitate this process in the study, our primary objective will be comparison of area under the receiver operating characteristic curves(AUROCs) of bedside based ultrasound weaning indices measuring parasternal intercostal muscle thickening fraction/diaphragm thickening fraction ratio(PMTF/DTF) and diaphragm thickening fraction/rapid shallow breathing index ratio (DTF/RSBI) and respiratory drive parameter including airway occlusion pressure (P0.1) in critically ill mechanically ventilated patients to predict weaning outcomes and minimize extubation failure. The secondary objectives would be to compare P0.1, PMTF/DTF ratio and DTF/RSBI ratios on subsequent spontaneous breathing trials, and to correlate PMTF and DTF on the day of discharge from the ICU with the number of days of mechanical ventilation and length of stay . The ultrasound based respiratory indices have a good ability to predict weaning and extubation outcomes. So, by using these indices & parameters together they can serve as a valuable tool for precise clinical prediction of weaning outcomes |