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CTRI Number  CTRI/2021/01/030817 [Registered on: 28/01/2021] Trial Registered Prospectively
Last Modified On: 22/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Efficacy of mechanical power in predicting weaning of patients from invasive ventilation, who are on mechanical ventilator for acute worsening of chronic obstructive pulmonary disease  
Scientific Title of Study   Efficacy of Mechanical Power in Predicting Weaning Outcome of Patients receiving Invasive Mechanical Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Udhayachandhar R 
Designation  Senior Resident Academic 
Affiliation  All India Institute of Medical Sciences,Rishikesh 
Address  Department of Anesthesiology, AIIMS RISHIKESH, Virbhadra Marg,Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9788385166  
Fax    
Email  udcsmg86@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gaurav Jain 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences,Rishikesh 
Address  Department of Anesthesiology, AIIMS RISHIKESH, Virbhadra Marg,Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8808631209  
Fax    
Email  gauravhld@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gaurav Jain 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences,Rishikesh 
Address  Department of Anesthesiology, AIIMS RISHIKESH, Virbhadra Marg,Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8808631209  
Fax    
Email  gauravhld@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, AIIMS Rishikesh 
 
Primary Sponsor  
Name  None 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
None   NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr UDHAYACHANDHAR R  Critical Care Unit  Level 6, Department of Anaesthesiology, AIIMS Rishikesh, Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL 		 9788385166

udcsmg86@gmail.com 
 
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: J441||Chronic obstructive pulmonary disease with (acute) exacerbation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Admision to ICU for acute exacerbation of chronic obstructive pulmonary disease
2.Acute respiratory failure (PaCO2 > 50 mm Hg, PaO2 <60 mm Hg, pH<7.2, increased work of breathing)
3.Tracheal intubation with controlled mechanical ventilation
 
 
ExclusionCriteria 
Details  1. Pregnancy
2. History of neuromuscular disease
3. Chest wall deformities
4. Intracranial hypertension
5. Septic shock.
6. Refusal to consent.
7. Need of mechanical ventilation for less than 24hr hours
8. Respiratory failure requiring invasive mechanical ventilation for condition other than acute exacerbation of chronic obstructive pulmonary disease
9. Existing tracheostomy
10. Required long term ventilation within past 3 months.
11. Associated Interstitial lung disease
12. Lobar pneumonia
13. Presence of pulmonary edema
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of mechanical power (on invasive mechanical ventilation) in predicting difficult weaning of patients with acute exacerbation of chronic obstructive pulmonary disease.  At admission after 15 minutes of intubation and initiation of invasive mechanical ventilation (Day 1)
At 24 hours(Day2)
Day2-Day28 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of mechanical power (on invasive mechanical ventilation) in predicting simple weaning of patients with acute exacerbation of chronic obstructive pulmonary disease.  At admission after 15 minutes of intubation and initiation of invasive mechanical ventilation (Day 1)
At 24 hours(Day2)
Day2-Day28 
To analyse correlation between positive end expiratory pressure and mechanical power in patients receiving invasive mechanical ventilation for acute exacerbation of chronic obstructive pulmonary disease.  At admission after 15,20,25,30,35,40,45,50,55,60,65 minutes of intubation and initiation of invasive mechanical ventilation (Day1)
At 24 hours(Day2)
 
Baseline parameters (Demographics, SOFA score, APACHE II score, Arterial blood gas, diagnosis and co-morbidities).   At admission(Day1)
 
Other outcome parameters (morbidities in ICU, nutritional parameters, prolonged weaning, unsuccessful weaning, Post-extubation NIV need, Post-extubation failure, ventilator free days, ICU length of stay, ICU free days, in-hospital length of stay, readmission to ICU, ICU mortality, and 28-day mortality)   Day1-Day28 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
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)   01/02/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Invasive Mechanical Ventilation is aimed at unloading respiratory muscles of excessive load in patients with Acute exacerbation of chronic obstructive pulmonary disease. Mechanial Power (MP)  is the amount of energy transferred to respiratory system with each breath to overcome the airway resistance and thoracic wall elastance. Requirement of higher MP aggravates lung injury. We hypothesize that higher need to MP at baseline or at 24 hours, in patients initiated on Invasive Mechanical Ventilation at ICU admission for Acute Exacerbation of chronic obstructive pulmonary disease, would relate to difficult weaning. It would help in identifying at risk patients and to develop targeted protocols for weaning in such patients.

 
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