| CTRI Number |
CTRI/2025/12/098735 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing outcome in adult intubated patients after giving spontaneous breath trial in pressure support mode and T piece mode |
|
Scientific Title of Study
|
Comparing partial pressure of oxygen in Pressure Support Ventilation vs T piece during spontaneous breathing trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHUMIKA THAKUR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES , BANARAS HINDU UNIVERSITY |
| Address |
Department of Anesthesiology INSTITUTE OF MEDICAL SCIENCES , BANARAS HINDU UNIVERSITY , Varanasi , Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9479210097 |
| Fax |
|
| Email |
bhumikathakur15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SANDEEP LOHA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCE, BANARAS HINDU UNIVERSITY |
| Address |
Department of Anesthesiology INSTITUTE OF MEDICAL SCIENCE , BANARAS HINDU UNIVERSITY, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8960919866 |
| Fax |
|
| Email |
drsandeepscb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SANDEEP LOHA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY |
| Address |
Department of Anesthesiology INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY, Varanasi , Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8960919866 |
| Fax |
|
| Email |
drsandeepscb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, Banaras Hindu University, Varanasi, ,Uttar Pradesh, Pincode -221005 |
|
|
Primary Sponsor
|
| Name |
Bhumika Thakur |
| Address |
Department of Anesthesiology Institute of Medical Sciences , Banaras Hindu University, Varanasi , Uttar Pradesh,Pincode 221005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhumika Thakur |
Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University |
CSSB Building, Intensive Care Unit, Department of Anesthesiology
Varanasi
UTTAR PRADESH |
9479210097
bhumikathakur15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BANARAS HINDU UNIVERSITY INSTITUTE OF MEDICAL SCIENCES , INSTITUTIONAL ETHICS COMMITTEE VARANASI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Spontaneous Breathing Trial with Pressure Support Ventilation mode |
During spontaneous breath trial before extubation we are using pressure support mode of trail.
Keeping minimum pressure support of 6-8 and PEEP 5 and minimum Fio2 to maintain spo2 of atleast 95 percent |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patient who had received more than 24 hours of mechanical ventilation and met checklist of readiness to start reduction of mechanical ventilation support |
|
| ExclusionCriteria |
| Details |
Refusal for consent
Traumatic brain injury or pre-existing neuromuscular disease
Patients with do not reintubate order
Patient undergone thoracic surgery or with diaphragmatic paralysis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Partial pressure of oxygen level difference pre and post extubation
Oxygen requirement post extubation to keep spO2 more than 94% |
Duration of spontaneous breathing trial 30 minutes to 120 minutes
Spo2 more than 94%
Partial pressure oxygen level before spontaneous breath trial then after extubation at 1st hour and 2nd hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reintubation rate
Atelectasis assessment by USG pre & post extubation |
Reintubation rate assessed within 48 hours after extubation
Atelectasis assessment done at before spontaneous breathing trial, after spontaneous breathing trial, after extubation & 48 hours after extubation |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
20/12/2025 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is single blinded prospective randomised control trial comparing spontaneous breathing trail mode that is pressure support ventilation vs T piece trial mode in adult patients and will be carried out in ICU of Institute of Medical Sciences , Banaras Hindu University, Varanasi. Primary outcome is change in partial pressure of oxygen before and after extubation in T piece mode vs pressure support ventilation mode. Secondary outcome is Comparing atelectasis development after spontaneous breathing trial with pressure support ventilation vs T piece mode. And minimal Oxygen concentration required after extubation to maintain Spo2 of more than 94%. |