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CTRI Number  CTRI/2023/05/053347 [Registered on: 31/05/2023] Trial Registered Prospectively
Last Modified On: 30/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing pressure support ventilation and T-piece as methods of spontaneous breathing trials for weaning the ICU patients from ventialtor support . 
Scientific Title of Study   Study to compare pressure support ventilation and T-piece as strategies of spontaneous breathing trials for weaning in ICU 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Monica Chhikara 
Designation  Associate professor 
Affiliation  Pt BD Sharma PGIMS Rohtak 
Address  Dept. of Anaesthesiology and Critical Care Rohtak Haryana 124001

Rohtak
HARYANA
124001
India 
Phone  9468465746  
Fax    
Email  chhikara.monica@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Alka  
Designation  Junior Resident 
Affiliation  Pt BD Sharma PGIMS Rohtak 
Address  Dept. of Anaesthesiology and Critical Care Rohtak Haryana 124001

Rohtak
HARYANA
124001
India 
Phone  8053305215  
Fax    
Email  dahiyaalka1995@gmail.com  
 
Details of Contact Person
Public Query  
Name  Alka 
Designation  Junior Resident 
Affiliation  Pt BD Sharma PGIMS Rohtak 
Address  Dept. of Anaesthesiology and Critical Care Rohtak Haryana 124001

Rohtak
HARYANA
124001
India 
Phone  8053305215  
Fax    
Email  dahiyaalka1995@gmail.com  
 
Source of Monetary or Material Support  
Pt BD Sharma University of Health Science PGIMS Rohtak Haryana 
 
Primary Sponsor  
Name  Pt BD Sharma University of Health Sciences Rohtak Haryana 
Address  Dept. of Anaesthesiology and Critical Care  
Type of Sponsor  Government 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 
Alka  PGIMS Rohtak Haryana  Dept of Anaesthesiology and Critical care ,PGIMS Rohtak Haryana
Rohtak
HARYANA 		 8053305215

dahiyaalka1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research 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 
Comparator Agent  NIL  NIL 
Intervention  spontaneous breathing trial for weaning from mechanical ventilation  Patients with age more than 18 years who are mechanically ventilated for minimum 24 hours but less than 7 days who are ready for spontaneous breahting trial will be given trial for weaning either by pressure support mode or by T-piece, ,patient will be put on Pressure Assist Control mode to achieve a tidal volume of 5 ml/kg and respiratory rate of 16-18 breaths per minute. If first separation attempt was not successful, pressure support will be decreased by 2-4 cm H2O,twice or thrice a day as tolerated by patient. Spontaneous breathing trial will be repeated after 24 hours of the previous trial. In T-piece group, the ventilator the endotracheal tube will be connected to a T–tube circuit with oxygen flow at 9-10 liter per minute. All patients will undergo a SBT for up to 60 minutes with monitoring every 20 minutes .Patient will be put on Pressure Assist Control mode to achieve a tidal volume of 5 ml/kg and respiratory rate of 16-18 breaths per minute. If first separation attempt was not successful, pressure support will be decreased by 2-4 cm H2O, twice or thrice a day as tolerated by patient. Spontaneous breathing trial will be repeated after 24 hours of the previous trial.These trials will be given for 1 week if patient will be not weaned off after 1 week it will be considerd weaning failure. According to the success of SBT patients will be classified in following four weaning groups: 1. Group NW: patients who never experienced any separation attempt (SA); 2. Group 1: the first SA resulted in termination of the weaning process within 1 day 3. Group 2: weaning was completed after more than 1 day but in less than 1 week after the first SA 4. Group 3: weaning was not terminated by 7 days after the first SA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with age more than 18 years who are mechanically ventilated for minimum 24 hours but less than 7 days who are ready for spontaneous breahting trial 
 
ExclusionCriteria 
Details  Patients with
1. On vasopressor or inotropic support
2. Patients with underlying COPD, interstitial lung disease,
damaged lung parenchyma due to any cause, single lung
bronchopleural fistula or having intercostal drain in situ.
3. Patients whose weaning was terminated due to cause unrelated
to weaning process.
4. Inability to obtain consent. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Comparison between success of T-piece trial and pressure support ventilation
for weaning according to WIND classification. 		 vitals recording and areterial blood gas analysis will be done at 20 minutes,40 minutes,and 60 minutes and second SBT will be given after 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To assess number of spontaneous breathing trials given for weaning in each group.  second SBT will be given after 24 hours and repeated untill success upto 1 week  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/05/2024 
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="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Spontaneous breathing trial is a method to identify readiness of extubation by incorporating a technique which allows gradual decrease in mechanical support of ventilator. SBT can be conducted by different methods like T-piece breathing, low level pressure support ventilation with or without PEEP, low level continuous airway pressure and flow trigger with no pressure applied to airway. There are some advanced methods of SBT like closed-loop systems with intelligent modes, adaptive support ventilation (ASV), neurally adjusted ventilatory assist (NAVA), and proportional assisted ventilation (PAV). Low level PSV and T piece are most common methods used for SBT. Low level PSV includes a pressure of upto 8 cm H2O in adults and upto 10 cm H2O in pediatric patients. In T-piece trial, patients are disconnected from ventilator and put on t-tube with oxygen support of 9-11 litres /min. SBT can be given for 30 to 120 minutes and after that success of trial can be monitored using subjective and objective criteria.
Depending on success of these SBTs, weaning can be classified further according to different classifications to assess success of weaning. We will be using WIND criteria. According to the success of SBT patients will be classified in following four weaning groups: 1. Group NW: patients who never experienced any separation attempt (SA); 2. Group 1: the first SA resulted in termination of the weaning process within 1 day 3. Group 2: weaning was completed after more than 1 day but in less than 1 week after the first SA 4. Group 3: weaning was not terminated by 7 days after the first SA Patients who will not be weaned off after 7 days will be regarded as failure of weaning.

 
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