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CTRI Number  CTRI/2020/07/026864 [Registered on: 28/07/2020] Trial Registered Prospectively
Last Modified On: 10/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Efficacy Of Thoracic Fluid Content By Cardiometry in Predicting Weaning Failure In Icu.  
Scientific Title of Study   Efficacy Of Thoracic Fluid Content By Cardiometry in Predicting Weaning Failure In Icu- A Prospective Observational Study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karthik Ram A 
Designation  Senior Resident  
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pain medicine and Critical care. All India Institute of Medical Sciences. Ansari nagar. New delhi- 110029
All India Institute of Medical Sciences. Ansari nagar. New delhi- 110029
South West
DELHI
110029
India 
Phone  8870249190  
Fax    
Email  drakarthikram@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rahul kumar Anand 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pain medicine and Critical care. All India Institute of Medical Sciences. Ansari nagar. New delhi- 110029
All India Institute of Medical Sciences. Ansari nagar. New delhi- 110029
South West
DELHI
110029
India 
Phone  9013082271  
Fax    
Email  rahulanand00@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rahul kumar Anand 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pain medicine and Critical care. All India Institute of Medical Sciences. Ansari nagar. New delhi- 110029
All India Institute of Medical Sciences. Ansari nagar. New delhi- 110029
South West
DELHI
110029
India 
Phone  9013082271  
Fax    
Email  rahulanand00@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences. Ansari Nagar, New Delhi, Pincode- 110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology,Pain medicine and Critical care. All India Institute of Medical Sciences. Ansari Nagar. New Delhi - 110029  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Karthik Ram A  All India Institute of Medical Sciences  Department of Anaesthesiology ,Pain medicine and Critical care, Ansari Nagar, New Delhi -110029.
South West
DELHI 
8870249190

drakarthikram@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J969||Respiratory failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients consenting for the study
2. Patients mechanically ventilated for more than 48 hours.
3. All patients considered eligible for a SBT by the attending physician as per standard ICU protocol: FiO2 < 0.5, PEEP ≤ 5 cm H2O, PaO2 /FiO2 > 200, respiratory rate <30 breaths per minute, absence of fever, alert and cooperative, and hemodynamic stability in the absence of high doses of vasopressor therapy.
 
 
ExclusionCriteria 
Details  1. Patients on short term mechanical ventilation in the immediate postoperative period.
2. Patients aged <18 years
3. Patients with spinal cord injury above T8 level
4. Presence of significant cardiac arrhythmia
5. Patients with diaphragmatic paralysis
6. Patients planned for prophylactic noninvasive ventilation after extubation.
7. Patients in whom a suitable ultrasonographic image could not be obtained for lung, diaphragm and cardiac measurements.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1.To assess if the thoracic fluid content (TFC) measured at the beginning of SBT by
cardiometry can predict weaning success or failure.

 
To Assess before spontaneous breathing trial and within 48hours of spontaneous breathing trial 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess if the lung ultrasound score, echocardiographic parameters and NT Pro BNP measured before SBT either alone or in combination can predict weaning failure.
2.To assess the correlation between TFC and extravascular lung water index(EVLWI)
 
To Assess before spontaneous breathing trial and within 48hours of spontaneous breathing trial 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/08/2020 
Date of Study Completion (India) 15/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="2"
Days="2" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

     

Mechanical ventilation is provided in intensive care unit when the  patient is unable to

 

maintain spontaneous  respiration on their own in order to sustain life.Weaning is a process

 

of  gradual  liberalization from the  ventilator support after  the  resolution of  primary illness.

 

Weaning failure is defined as failure in tolerating spontaneous  breathing trial (SBT ) or the

 

need for  invasive or non- invasive ventilation within 48 hours of extubation. Neuro-muscular

 

disease, nutritional deficiency,metabolic disturbance,Cardiac dysfunction and  respiratory

 

disease are the various causes of weaning failure.

 

Liu et al, conducted a study in critically ill patients and found that weaning  induced

 

pulmonary edema attributed to 40% of unsuccessful SBT. Although the patho-physiology of

 

weaning induced pulmonary edema remains complex ,transition from mechanical ventilator

 

support to spontaneous breathing leads to physiological changes like  increased pre-load

 

,after - load ,work of  breathing ,adrenergic tone  and  increased myocardial oxygen

 

consumption thereby leading  to elevated pulmonary venous pressure and pulmonary edema

 

effectuating weaning failure.Patients  with  borderline left  ventricular systolic and diastolic

 

function, Chronic obstructive pulmonary disease, especially with  positive cumulative fluid

 

balance are at increased risk  for  weaning failure. Weaning  failure  results  in  prolonged

 

ventilatory demand , lengthened  intensive care unit stay and  hence increased morbidity

 

and mortality.Since the  incidence of  weaning failure  remains high ,a profound  knowledge

 

regarding  the  risk  factors,pathogenesis ,prediction ,diagnosis and management of

 

weaning failure  is very  much essential to curtail it. Hence  a  detailed  assessment done

 

before  SBT, during  and  after  SBT could  help us  in preventing  weaning  failure.

 

Lung ultrasound score (LUS) is a useful tool  in  predicting weaning failure. Higher baseline

 

LUS  score and Loss of lung aeration during SBT are associated with high failure rates.A

 

LUS score < 13 % was associated with successful weaning. An integrated use of  lung usg,

 

diaphragmatic thickness fraction and trans -thoracic echo has shown a promising role in

 

predicting weaning  failure .Since there is no ideal single parameter to predict weaning

 

failure, a combination of methods is essential to assess neurology ,cardiovascular and

 

respiratory status.

 

Recently Thoracic fluid content, a novel parameter which  measures the whole fluid

 

(intravascular,extravascular)component in the thoracic cavity is analysed in predicting

 

weaning failure.A higher TFC value is associated with increased lung congestion and

 

hypervolemia, which is considered as a risk factor for difficult weaning.Thoracic fluid content

 

has advantages like easy measurement by the physician and paramedics, lack of  inter-

 

observer variations because of minimal fluctuations in the numerical value.

 

We hypothesize that Thoracic fluid content measured by cardiometry  has a promising role

 

and can be used as an adjuvant non invasive tool in  predicting weaning failure.Hence in our

 

study we combine  measuring the Thoracic fluid content along with Lung utrasound score

 

Echocardiography, Pulmonary vascular permeability index and Extravascular lung water

 

index to ascertain the efficacy of  thoracic fluid content  measured  by cardiometry  in

 

predicting  weaning failure .

 
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