| CTRI Number |
CTRI/2025/03/083407 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using Breathing Muscle Strength, Airway Pressure, and Lung Ultrasound to Predict Breathing Support Removal in Critically Ill Patients |
|
Scientific Title of Study
|
Combination of respiratory muscle strength, P0.1 and lung ultrasound score to predict weaning failure from mechanical ventilation in critically ill patients: A prospective observational study. |
| Trial Acronym |
CRPLUS trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jadav Sainath |
| Designation |
Senior resident |
| Affiliation |
Department of anaesthesiology and critical care AIIMS Raipur |
| Address |
ccu
2nd floor
trauma building
aiims raipur anaesthesia department B Block aiims raipur Raipur CHHATTISGARH 492099 India |
| Phone |
8500028673 |
| Fax |
|
| Email |
jadav.sainath@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Chinmaya k panda |
| Designation |
associate professor |
| Affiliation |
Department of anaesthesia and critical care AIIMS Raipur |
| Address |
ccu
2nd floor
trauma building
aiims raipur Anaesthesia department B block
AIIMS Raipur Raipur CHHATTISGARH 492099 India |
| Phone |
8098007711 |
| Fax |
|
| Email |
chinmaya.panda06@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Jadav Sainath |
| Designation |
Senior resident |
| Affiliation |
Department of Anaesthesia and critical care AIIMS Raipur |
| Address |
ccu
2nd floor
trauma building
aiims raipur Anaesthesia department B Block
AIIMS Raipur Raipur CHHATTISGARH 492099 India |
| Phone |
8500028673 |
| Fax |
|
| Email |
jadav.sainath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology & Critical Care, AIIMS Raipur, Chhattisghar, 492099 |
|
|
Primary Sponsor
|
| Name |
Jadav Sainath |
| Address |
ccu
2nd floor
trauma building
aiims raipur, chhattisgarh, india 492099 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Jadav Sainath |
AIIMS Raipur |
2nd Floor, Department of Anesthesiology and Critical Care, Trauma Building Raipur CHHATTISGARH |
8500028673
jadav.sainath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All india institute of medical sciences, raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z991||Dependence on respirator, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LUNG ULTRASOUND |
Lung Ultrasound score, Respirstory Muscle Strength assessment by ultrasonography 30 mins after Spontaneous Breathing Trial |
| Intervention |
Mechanical Ventilation |
P0.1 value assessment on ventilator 30 mins after Spontaneous Breathing Trial |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient eligible for SBT after 48 hrs of mechanical ventilation in CCU
Positive end-expiratory pressure less than or equal to 6 cm H2O
Partial Pressure of Arterial Oxygen more than or equal to 60 mmHg with fraction of inspired oxygen less than 0.45
GCS more than 13
Richmond Agitation Sedation Scale -1 to +1
Body Temperature less than 38 degree Celsius
Hematocrit level more than 21% or Hemoglobin level more than 7 g/dL
No or low doses of vasopressor support |
|
| ExclusionCriteria |
| Details |
Patients with difficulty in obtaining ultrasound window
Mechanical Ventilation less than 48 hrs
History of Diaphragmatic Paralysis or Injury
Ascites
Thoracotomy
Pneumothorax
Pleural Effusion
Thoracic Trauma
History of Neuromuscular Disease
Pregnant women
Lactating or nursing mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the power of the Combination of respiratory muscle strength, P0.1 and
lung ultrasound score will predict weaning failure from mechanical ventilation in
critically ill patients. |
30 mins after Spontaneous Breathing Trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess Extubation failure |
Upto 48 hours after extubation |
| Requirement of noninvasive respiratory support after extubation |
Upto 48 hours after extubation |
|
|
Target Sample Size
|
Total Sample Size="149" Sample Size from India="149"
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)
|
07/04/2025 |
| 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 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 - NO
|
|
Brief Summary
|
This thesis focuses on predicting weaning failure from mechanical ventilation in critically ill patients using a combination of respiratory muscle strength, airway occlusion pressure at 100 milliseconds (P0.1), and lung ultrasound score (LUS). Weaning from mechanical ventilation is a critical process in intensive care units (ICUs), where both premature and delayed extubation can lead to serious complications, including diaphragm dysfunction, ventilator-associated pneumonia, and airway trauma. The study builds on prior research that has established the utility of different physiological markers in predicting weaning outcomes. The LUS, developed by Bouhemad et al., assesses lung aeration and has been shown to be an effective predictor of post-extubation distress. Similarly, diaphragmatic thickness and thickening fraction (DTF) have been linked to successful weaning. The P0.1 index, which measures central respiratory drive, has also been found to predict extubation success. This observational study, conducted in a critical care unit, aims to integrate these parameters to improve the accuracy of weaning predictions. It involves assessing patients undergoing spontaneous breathing trials (SBT) through bedside ultrasonography, lung ultrasound, and respiratory drive monitoring. The study population includes critically ill patients eligible for weaning after at least 48 hours of mechanical ventilation, with specific inclusion and exclusion criteria to ensure valid results. The methodology involves measuring LUS, diaphragmatic and intercostal muscle thickness, and P0.1 during the SBT, followed by statistical analysis to determine their predictive power. Ethical considerations include obtaining informed consent and ensuring patient safety. The expected outcome is that the combined assessment of these physiological markers will provide a more reliable predictor for weaning success, reducing re-intubation rates and improving patient outcomes in the ICU. |