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CTRI Number  CTRI/2022/03/041133 [Registered on: 16/03/2022] Trial Registered Prospectively
Last Modified On: 15/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Checking the efficacy of lung and diaphragm ultrasonography in weaning of patients from mechanical ventilation in intensive care settings 
Scientific Title of Study   Use of lung and diaphragm ultrasonography as non-invasive indicators of weaning outcome in intensive care settings: An observational cohort study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sonika Agarwal 
Designation  Professor 
Affiliation  Himalayan institute of medical sciences 
Address  Department of Anaesthesia and Critical care, Swami Rama Himalayan University, HIMS, Jollygrant, Dehradun, Uttarakhand

Dehradun
UTTARANCHAL
248140
India 
Phone  6396918163  
Fax    
Email  sonikakatiyar@srhu.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Poorva Goyal 
Designation  Post graduate resident  
Affiliation  Himalayan institute of medical sciences 
Address  Department of Anaesthesia and Critical Care, Swami Rama Himalayan University, HIMS, Jollygrant, Dehradun, Uttarakhand

Dehradun
UTTARANCHAL
248140
India 
Phone  7895413661  
Fax    
Email  poorvagoyal.020595@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Poorva Goyal 
Designation  Post graduate resident  
Affiliation  Himalayan institute of medical sciences 
Address  Department of Anaesthesia and Critical Care, Swami Rama Himalayan University, HIMS, Jollygrant, Dehradun, Uttarakhand

Dehradun
UTTARANCHAL
248140
India 
Phone  7895413661  
Fax    
Email  poorvagoyal.020595@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Himalayan Institute of Medical Sciences, Swami Ram Nagar, Jollygrant, Dehradun 
 
Primary Sponsor  
Name  Himalayan Institute of Medical Sciences 
Address  Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun 
Type of Sponsor  Private medical college 
 
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 
Dr Sonika Agarwal  Himalayan institute of medical sciences  Department of anaesthesia and critical care, Swami Rama Himalayan University, HIMS, Jollygrant, Dehradun, Uttarakhand
Dehradun
UTTARANCHAL 
6396918163

sonikakatiyar@srhu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Age between 18-65 years,
2) Patients who have been in an intubated state
since a minimum of 48 hours,
3) Excessive tracheobronchial secretions not
present,
4) The underlying critical illness (their reason
for intubation) must have been resolved,
5) Patients fulfilling the criteria of
conventional methods for weaning from
mechanical ventilation.










































 
 
ExclusionCriteria 
Details  1) Hemodynamic instability requiring vasopressors,
2) Gas exchange impairment requiring positive end-
expiratory pressure (PEEP) >10 cmH2O and/or
FIO2 > 50% to obtain a PaO2 > 60 mmHg,
3) Pressure support (PS) level > 20 cmH2O,
4) Deep sedation,
5) History of chronic obstructive pulmonary
disease, neuromuscular disease, anatomical
malformation of the diaphragm or use of muscle
paralyzing agents, aminoglycosides and
corticosteroids,
6) Pneumothorax or pneumomediastinum, increased
intra-abdominal pressure,
7) Aseptic dressings over the chest that can
hamper the process of ultrasonography.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Sensitivity and specificity of USG indices as predictors of weaning outcome.
2. Positive predictive value (PPV), Negative predictive value (NPV) and diagnostic accuracy of USG indices as predictors of weaning outcome.
 
To check if patient got reintubated within 48 hours post extubation 
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparison of traditional indices such as RSBI with USG indices as predictors of difficult weaning  checking for reintubation within 48 hours after extubation 
 
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)   20/03/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/03/2022 
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)?  

Response - NO
Brief Summary  

Almost 20% of the patients in the intensive care unit (ICU) on mechanical ventilation (MV), experience difficult and prolonged weaning, even after thorough observation and application of the weaning criteria. Conventional methods like regular assessment of breathing frequency, minute ventilation, and negative inspiratory force have little impact in improving the decision of timing of successful extubation. RSBI has been accepted as a successful guide for correct timing of extubation with spontaneous breathing trials.

Diaphragmatic dysfunction being a common cause of weaning failure, needs to be assessed during weaning . Ultrasonography has emerged as a promising solution to overcome failed extubations and has been extensively studied over the past few years.  USG can easily allow direct visualization of the diaphragm and help us in assessing its contractility and functional efficacy, thus leading to better prediction of weaning outcome and post extubation distress and its cause.  Thus, we can gain reassurance over and above the traditional indices for successful weaning.

We formulated a hypothesis that ultrasound guided weaning of a patient from mechanical ventilation may decrease the chances of reintubation. This study aims to prospectively investigate the value of lung and diaphragmatic ultrasonography in the prediction of weaning outcomes and chances of reintubation in patients being weaned from mechanical ventilation and comparing them with the traditional indices for weaning, like RSBI.

SAMPLE SIZE: 100

With reference to a previous study(1), the prevalence was taken as 67%.

The formula for calculated sample size is given below:

n = (Z 1- α/2 )2 x P(1-P)

                    d2

 

= (1.96)2 x 0.67(1- 0.67)

                 0.01

= 84.937 =85

Where, Zα/2 is the critical value of the Normal distribution at α/2 (e.g., α is 0.1 and the critical value is 1.96).

85 is the calculated minimum sample size.

METHODS:

·               All patients selected will be the ones already on mechanical ventilation via an endotracheal tube in situ.

·                Patients will be put to a SBT when they meet the weaning criteria. Patients will be put on Pressure Support/CPAP trial for half an hour. Failure of the weaning process shall be defined as a failed SBT or the need for reintubation/ NIV (non-invasive ventilatory support) within 48 hours following extubation , so all the patients included in the study will be observed for 48 hours after the SBT. The following weaning indices will be recorded for all patients during the SBT: Tidal volume (TV), Respiratory rate (RR), ABG: Po2, Spo2 % and Po2/Fio2, Rapid shallow breathing index: (RSBI (f/VT) = Respiratory rate/tidal volume.

·               Bedside ultrasound will be performed 20 minutes after initiation of SBT by a critical care consultant in the ICU, well versed with the use of bedside lung and abdominal ultrasonography and its interpretation. Initial USG will be done immediately after putting the patient on SBT to check the anatomy of the diaphragm and to rule out patients according to exclusion criteria. This will be followed by a complete diaphragmatic and lung USG after 20 minutes of initiation of SBT. Three readings shall be recorded for each USG index and an average value of the three recordings shall be used further.  After the extubation, all patients will be monitored for failed or successful weaning. Weaning will be considered successful if the patient did not require noninvasive or invasive ventilation within 48 hours of extubation. At the end of the study, the patients will be divided into two groups: successful group and failed group (re‑intubation within 48 h after extubation) according to their response to weaning trials.

The Diaphragmatic Excursion, Diaphragmatic Thickness Fraction %, diaphragmic contraction (DC), and LUSm( modified Lung Ultrasound Score) score measurements will be collected for each group and then will be correlated with RSBI.






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