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CTRI Number  CTRI/2020/02/023166 [Registered on: 06/02/2020] Trial Registered Prospectively
Last Modified On: 12/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Other (Specify) [ICU INTERVENTION ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of removal of a patient from ventilator by giving external positive pressure before disconnecting and removing the endotracheal tube with the traditional method of endotracheal tube removal without giving external positive pressure in Critically Ill Patients 
Scientific Title of Study   Comparison of Positive Pressure Extubation with Traditional Extubation in critically ill patients- A Randomised control 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 AJEETVISWANATH TP 
Designation  SENIOR RESIDENT 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES  
Address  Department of Anesthesiology, Pain Medicine and Critical care Room no 16 4th floor Academic block AIIMS New Delhi Ansari Nagar

South
DELHI
110029
India 
Phone  9176591005  
Fax    
Email  avtp1989@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR DARLONG V 
Designation  PROFESSOR 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI 
Address  Department Of Anesthesiology Pain Medicine and Critical Care Room no 5 4th floor Academic block AIIMS NEW DELHI Ansari nagar

South
DELHI
110029
India 
Phone  9821607809  
Fax    
Email  darlongv@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DR DARLONG V 
Designation  PROFESSOR 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI 
Address  Department Of Anesthesiology Pain Medicine and Critical Care Room no 5 4th floor Academic block AIIMS NEW DELHI Ansari nagar

South
DELHI
110029
India 
Phone  9821607809  
Fax    
Email  darlongv@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology Pain Medicine and Critical Care All India Institute Of Medical Sciences - Ansari nagar NEW DELHI 110029 
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI 
Address  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 
DR DARLONG V  ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI  AB8 ICU and Trauma Care -2 ICU Department of Anesthesiology pain medicine and critical care AIIMS ANSARI NAGAR NEW DELHI-110029
South
DELHI 		 9821607809

darlongv@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee For post graduate research, AIIMS  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 
Intervention  Positive pressure extubation  After a successful spontaneous breathing trial, thorough oral suctioning of the patients in the ICU will be done. The patients in this group will then be connected back to the ventilator with a Pressure support of 15 cm H2O and a PEEP of 10 cm H2O. After 5 minutes the cuff will be deflated and the patient will be extubated by the physician in charge without endotracheal suctioning, with the endotracheal tube still connected to the ventilator. Post extubation, a suction catheter will be introduced in the oral cavity for removing secretions. 
Comparator Agent  Traditional extubation  Once the spontaneous breathing trial is successful, the patients in this group will not be reconnected to the ventilator. After thorough tracheal and oral suctioning, cuff deflation and extubation will be done by the physician in charge in the ICU. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients mechanically ventilated with an endotracheal tube for at least 72 hours
Patients deemed fit for extubation by the following criteria or by the physicians discretion
PaO2 greater than or equal to 60 mm Hg on FIO2 lesser than or equal to 50 percentage
SaO2 greater than or equal to 90% on FIO2 lesser than or equal to 50 percentage
pH greater than or equal to 7.32 or a decrease in pH less than 0.07 from baseline of SBT
Rapid shallow breathing index less than 105 breaths per min per Litre
Respiratory rate less than or equal to 35 breaths per min or increase less than 50 percentage from baseline of SBT
Hemodynamically stable patient
Successful T-piece or Pressure support ventilation trial for 30 minutes
 
 
ExclusionCriteria 
Details  Patients planned in advance to be extubated directly to NIV or High flow nasal cannula
Patients with severe asthma bullous lung disease or severe emphysematous lung disease
Patients with suspected raised ICP
Patients with a poor GCS of less than 8
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of lung aeration of patients who undergo traditional extubation with those undergoing positive pressure extubation using lung ultrasound.  End of SBT
30 Mins Post Extubation
6 Hours Post Extubation
24 Hours Post Extubation 
 
Secondary Outcome  
Outcome  TimePoints 
Chest X-ray findings between the two groups  Before Extubation
24 Hours Post Extubation 
Change in the A-aO2 gradient pre and post extubation in the two groups  End Of SBT
1 Hour Post Extubation 
Change in lung ultrasound scores pre and post extubation in the two groups  End of SBT
30 Mins Post Extubation
6 Hours Post Extubation
24 Hours Post Extubation 
Incidence of adverse clinical events between the two groups  Extubation failure within 48 hours
Desaturation within 48 hours
New onset bronchospasm within 48 hours
Tachypnea within 30 minutes
Tachycardia within 30 minutes
Hypertension within 30 minutes
Pneumonia within 48 hours
 
ICU free days and Reintubation rates between the two groups  ICU free days at 28 days
Reintubation rates at 72 hours and 28 days 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/02/2020 
Date of Study Completion (India) 30/06/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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)?  

Response - NO
Brief Summary
Modification(s)  

The patient who is in the ICU and is connected to a ventilator using an endotracheal tube for atleast 72 hours, will undergo treatment as per the hospital protocol. All baseline medical details and cause of admission will be noted. A baseline Chest X-ray will be taken before extubation as well as within 24 hours after extubation. The patient will either be in the positive pressure or traditional extubation group based on a randomization process. Based on the group he/she will be extubated after tracheal suctioning and deflation of the cuff directly or extubated after 5 minutes of further ventilator support (PS -15 cm H2O , PEEP- 10 cm H2O) without tracheal suctioning. Lung ultrasound will be done before extubation and at various time periods (30 mins, 6 hrs, 24 hrs) after extubation. Blood samples of the patient will be taken for monitoring the oxygenation of the patient. Sputum samples of the patient will be taken for culture and antibiotic sensitivity if needed as per hospital protocol. Our research work involves observing and noting down these lab results of the patient for 48 hours after the patient is extubated.   Apart from these lab values, we will also note down other details of the patient during their ICU stay, like the need for reintubation, any changes in blood pressure, heart rate, respiratory rate or oxygen levels in the blood, any worsening in chest X-ray films or any other adverse events such as pneumonia and bronchospasm. Lung USG scores will be compared between the 2 groups. Reintubation rates and ICU free days are also calculated. Our aim is to assess whether lung aeration improves after positive pressure extubation and whether other parameters measured are improved after the same.

 
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