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CTRI Number  CTRI/2020/02/023466 [Registered on: 20/02/2020] Trial Registered Prospectively
Last Modified On: 15/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARISON OF TWO METHODS FOR WEANING A PATIENT FROM MECHANICAL VENTILATOR. 
Scientific Title of Study   Comparison of Pressure support ventilation and T-piece ventilation during spontaneous breathing trials on successful extubation among patients on mechanical ventilation. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Johnson 
Designation  Junior Resident 
Affiliation  PONDICHERRY INSTITUTE OF MEDICAL SCIENCES 
Address  61, CONVENT STREET, NELLITHOPE, PUDUCHERRY 605005.
KALAPET, PUDUCHERRY 605014.
Pondicherry
PONDICHERRY
605005
India 
Phone  8870789039  
Fax    
Email  lijo.bcool@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kurien Thomas  
Designation  Professor and HOD 
Affiliation  PONDICHERRY INSTITUTE OF MEDICAL SCIENCES 
Address  PONDICHERRY INSTITUTE OF MEDICAL SCIENCE KALAPET PONDICHERRY
KALAPET PUDUCHERRY 605014.
Pondicherry
PONDICHERRY
605014
India 
Phone  9790014548  
Fax    
Email  kurien123@gmail.com  
 
Details of Contact Person
Public Query  
Name  Johnson 
Designation  Junior Resident 
Affiliation  PONDICHERRY INSTITUTE OF MEDICAL SCIENCES 
Address  61, CONVENT STREET, NELLITHOPE, PUDUCHERRY 605005.
KALAPET, PUDUCHERRY 605014.

PONDICHERRY
605005
India 
Phone  8870789039  
Fax    
Email  lijo.bcool@gmail.com  
 
Source of Monetary or Material Support  
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES GANAPATHICHETTIKULAM KALAPET PONDICHERRY 605014 
 
Primary Sponsor  
Name  Johnson 
Address  61, Convent street, Nellithope, Puducherry 605005 
Type of Sponsor  Other [SELF] 
 
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 
Johnson  PONDICHERRY INSTITUTE OF MEDICAL SCIENCES  KALAPET, PUDUCHERRY 605014.
Pondicherry
PONDICHERRY 		 8870789039

lijo.bcool@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J969||Respiratory failure, unspecified, (2) ICD-10 Condition: G988||Other disorders of nervous system, (3) ICD-10 Condition: I999||Unspecified disorder of circulatory system, (4) ICD-10 Condition: T449||Poisoning by, adverse effect of and underdosing of other and unspecified drugs primarily affecting the autonomic nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pressure support spontaneous breathing trial with 8 cm H2O pressure  Pressure support ventilation is a mode of spontaneous breathing trial used during weaning trials in patients on mechanical ventilation. 
Comparator Agent  Spontaneous breathing trial with T-piece ventilation   T-piece ventilation is a commonly used mode of spontaneous breathing trial in weaning of patients on mechanical ventilation. A T shaped tube will be attached to the already existing circuit of mechanical ventilator for a duration of 2 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Patients aged 18 years or older.
2.Patients undergoing mechanical ventilation for atleast 24 hours considered eligible for weaning by the following weaning criteria:
A.Patient who are alert and co-operative.
B.The resolution or improvement of the condition leading to intubation.
C.Hemodynamical stability, defined as systolic blood pressure between 90 and 160 mmHg and heart rate less than 140/min without vasopressors or with low doses of vasopressors.
D.Glasgow coma scale of 8 or greater.
E.Respiratory stability, defined as oxygen saturation > 90% with FiO2 < 0.5, PEEP ≤ 5cm H2O, respiratory rate < 30/min, spontaneous tidal volume > 5mL/kg, PF ratio > 200.
F.Non-copious secretions (<3 aspirations in the last 8 hours).
G.Diaphragmatic thickness fraction > 28.
H.Rapid shallow breathing index ≤ 105.
I.Patients in spontaneous intermittent mandatory ventilation (SIMV) mode with a pressure support of 8. 
 
ExclusionCriteria 
Details  1.Pregnant women.
2.Patients with diaphragm paralysis.
3.Patients with neuromuscular disorders.
4.Patients on tracheostomy. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare pressure support ventilation and T-piece ventilation in providing successful extubation among mechanically ventilated patients.  3 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine the rate of successful extubation.
2.To determine the rate of weaning failure
3.To estimate the 28-day mortality rate. 		 28 days 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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   Phase 2 
Date of First Enrollment (India)   24/02/2020 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Burns KEA, Soliman I, Adhikari NKJ, Zwein A, Wong JTY, Gomez-Builes C, et al. Trials directly comparing alternative spontaneous breathing trial techniques: a systematic review and meta-analysis. Crit Care. 2017 Dec;21(1):127. Subirà C, Hernández G, Vázquez A, Rodríguez-García R, González-Castro A, García C, et al. Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jun 11;321(22):2175. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Delayed weaning can lead to a number of complications like ventilator induced lung injury (VILI), ventilator associated pneumonia (VAP) and ventilator induced diaphragmatic dysfunction. In an intensive care unit, spontaneous breathing trials are routinely conducted to facilitate decision making regarding timely extubation and to reduce the patient’s chance of getting into the above-mentioned unfavorable conditions or invasive ventilation. Daily SBTs are the best approach to determine whether patients are ready for disconnection from mechanical ventilation, but mode and duration remains controversial. Hence in this study, pressure support and T-piece SBTs are compared in providing successful extubation.

 

Research question / hypothesis:

Whether a 30-minute Pressure support ventilation as compared to a 2-hour T-piece ventilation has atleast 15% higher rates of successful extubation among adult patients on mechanical ventilation?

 

Study procedure:

A.    Patients in MICU and emergency ICU who fulfil the inclusion criteria will be recruited to the study.

B.    Once the patient is found to satisfy the inclusion criteria, consent will be taken from the patient for recruitment into the study. If the patient cannot give consent, consent will be obtained from his next of kin.

C.    Participants will be randomly divided into two arms (T-piece arm and pressure support arm).

D.    Detailed history and examination of all the patients will be documented.

E.    Patients under both arms will undergo baseline laboratory investigations like chest X-ray, arterial blood gas analysis, complete blood count, renal function tests, liver function test and serum electrolytes.

F.    Primary diagnosis will be established for all cases. APACHE II scores will be calculated and recorded.

G.   Patients in group A will undergo a 2-hour T-piece SBT.

H.   Similarly, Patients in group B will undergo a 30 minutes pressure support SBT with 8 cm H2O pressure.

I.      FiO2 will remain unchanged from the mechanical ventilation period leading upto the SBT.

J.     During weaning, if any patient fulfils the criteria for weaning failure, they will be considered failure of the particular weaning mode that he is on.

K.   Patients who complete the SBT successfully will be extubated and will be observed for the next 72 hours to see if they are capable of sustaining without reintubation or Non-invasive positive pressure ventilation. Patients who required reintubation or NIPPV as decided by the treating clinicians will be considered as weaning failure.

 
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