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CTRI Number  CTRI/2020/12/030097 [Registered on: 29/12/2020] Trial Registered Prospectively
Last Modified On: 26/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Ultrasound of the diaphragm to predict extubation outcomes in patients on ventilator 
Scientific Title of Study   Ultrasonographic diaphragmatic parameters as predictors of extubation outcomes in mechanically ventilated adult patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr U Krishna Chaitanya 
Designation  Post Graduate 
Affiliation  JSS Medical College and Hospital 
Address  Post graduate residents room - 1 Department of Anesthesiology JSS Medical college and Hospital Mahatma Gandhi Road

Mysore
KARNATAKA
570004
India 
Phone  9538738093  
Fax    
Email  krishna.c1390@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nalini Kotekar 
Designation  Professor 
Affiliation  JSS Medical College and Hospital 
Address  Professor Dr Nalini Kotekar, Professors room, Room -1 Department of Anesthesiology third floor JSS Medical college and Hospital Mahatma Gandhi Road

Mysore
KARNATAKA
570004
India 
Phone  9845112283  
Fax    
Email  nalinikotekar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nalini Kotekar 
Designation  Professor 
Affiliation  JSS Medical College and Hospital 
Address  Professor Dr Nalini Kotekar, Professors room, Room no 1 Department of Anesthesiology third floor JSS Medical college and Hospital Mahatma Gandhi Road

Mysore
KARNATAKA
570004
India 
Phone  9845112283  
Fax    
Email  nalinikotekar@gmail.com  
 
Source of Monetary or Material Support  
JSS Medical College and Hospital,Mysuru 
 
Primary Sponsor  
Name  JSS Medical College and Hospital 
Address  JSS Medical College and Hospital Mahatma Gandhi Road Mysuru - 570074 India 
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 U Krishna Chaitanya  JSS MEDICAL COLLEGE AND HOSPITAHOSPITAL  Surgical Intensive Care Unit (SICU), Medical Intensive Care Unit(MICU) and Respiratory Intensive Care Unit (RICU), ICU complex division, Department of anesthesiology third floor JSS HOSPITAL Mahatma Gandhi road 570004
Mysore
KARNATAKA 
9538738093

krishna.c1390@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Medical College and Hospital  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  80.00 Year(s)
Gender  Both 
Details  All mechanically ventilated patients with endotracheal tube aged ≥ 18 years who met the criteria for a spontaneous breathing trial  
 
ExclusionCriteria 
Details  Age < 18 years
Presence of pneumothorax or ascites
Unilateral or bilateral diaphragmatic palsy
Pregnancy
History of neuromuscular disease.
Patients who have undergone Tracheostomy
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate ultrasonographic diaphragmatic parameters namely diaphragmatic excursion, diaphragmatic contraction velocity and diaphragmatic thickness fraction as a predictor of weaning and extubation outcomes in mechanically ventilated patients  48 hours post extubation 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the ultrasonographic diaphragmatic parameters with each other in order to identify the most suitable parameter to predict extubation outcome.  48 hours post extubation 
2) To attempt to establish a relationship between number of ventilator days and ultrasonographic diaphragmatic parameters.  48 hours post extubation 
 
Target Sample Size   Total Sample Size="73"
Sample Size from India="73" 
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)   01/01/2021 
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="0"
Months="6"
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  

 This prospective study will be carried out on mechanically ventilated patients in the medical, surgical and respiratory intensive care units of JSS University hospital, a tertiary care center after obtaining approval from Institutional ethics committee and informed consent from the relatives of all enrolled patients.

 Patients on mechanical ventilator support for a period of ≥ 48hr will be assessed clinically by acute physiology and chronic health evaluation II (APACHE II) score.

  The decision to wean patients from ventilator support will be taken by the Intensivist and primary ICU team and put on a Spontaneous Breathing Trial (SBT) when patients meet the following criteria-

1)     Resolution of the underlying pathology that led to the need for intubation and ventilatory support

2)     Calm, Cooperative and easily arousable

3)     PaO2>60mmhg and PaCO2<50mmhg as assessed Arterial Blood Gas (ABG) analysis.

            4)FiO2<0.5

            5)Positive end expiratory pressure (PEEP)≤5

            6)PaO2/FiO2>200

            7)Respiratory Rate<35/min

            8)Hemodynamically stable without the need of vasopressor support.       

 

   Once the Intensivist and the primary ICU team decide that the patient has been successfully weaned from ventilator support, the patient will be put on a spontaneous breathing trail (SBT) under low level pressure support (pressure support ≤ 8 and PEEP ≤ 5  on PSV mode) or a T piece circuit for a period of 2 hours and the primary investigator called.

  Right hemidiaphragmatic parameters namely diaphragmatic excursion, diaphragmatic contraction velocity and diaphragmatic thickness fraction will be measured by the primary investigator 30 minutes into the 2 hour SBT using the GE LOGIQ P6 PRO ultrasound system.The Intensivist and the primary ICU team are blinded to these measurements.

   Tidal volume, respiratory rate, minute ventilation will be also measured and RSBI calculated at this time by the primary investigator.

  Patients who pass the SBT without any clinical deterioration will be extubated under the supervision of the Intensivist and the primary ICU team.

   Criteria for failure of SBT is defined as follows-

1)Alteration of mental status defined as a decrease in GCS <10

2)Respiratory rate > 35/min

3)Systolic Blood Pressure >180mmHg or < 90mmHg

4)Heart Rate >130bpm or increase in 20% from baseline heart rate

 All patients who successfully pass a SBT and extubated will be followed up for a period of 48 hours to assess for extubation failure and the need for reintubation.

  Extubation failure will be defined as patients who require reintubation or Noninvasive ventilatory support within 48hrs of extubation. The decision to reintubate or initiate Non Invasive Ventilatory support will be made by the Intensivist and primary ICU team based on their clinical and parametrical judgement.

 Based on the above observations, Patients are divided into two groups-

GROUP 1 – Patients who are successfully weaned of ventilator support, pass a SBT and extubated and do not require any non-invasive ventilatory support or reintubation within 48 hours of extubation.

GROUP 2 – Patients who do not pass a SBT or pass a SBT but require Non invasive ventilatory support or reintubation within 48 hours of extubation.

 
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