| CTRI Number |
CTRI/2025/07/091125 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
This study compares two settings of the breathing machine, ASV and PSV, to help ICU patients breathe on their own. ASV adjusts support automatically based on the patients needs, while PSV provides pressure based support that is manually adjusted. |
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Scientific Title of Study
|
Comparison of Adaptive Support Ventilation and Pressure Support Ventilation for Weaning and Extubation Outcomes in Critically Ill Patients in an Indian ICU: A Prospective Randomized Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devshankar Moosad E I |
| Designation |
Jr. Clinical Assistant |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Surgical ICU, Christian Medical college, Vellore, Tamilnadu.
Vellore
TAMIL NADU
632002
India |
| Phone |
6282903775 |
| Fax |
|
| Email |
devshankar.moosad@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
George Prashanth Kurian |
| Designation |
Consultant Surgical ICU |
| Affiliation |
Christian medical college, Vellore |
| Address |
Surgical ICU, Christian Medical college, Vellore, Tamilnadu
Vellore
TAMIL NADU
632002
India |
| Phone |
9655594316 |
| Fax |
|
| Email |
georgekurian14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
George Prashanth Kurian |
| Designation |
Consultant Surigical ICU |
| Affiliation |
Christian medical college, Vellore |
| Address |
Surgical ICU, Christian Medical college, Vellore, Tamilnadu
Vellore
TAMIL NADU
632002
India |
| Phone |
9655594316 |
| Fax |
|
| Email |
georgekurian14@gmail.com |
|
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Source of Monetary or Material Support
|
| Fluid research fund, Christian Medical College, Vellore, Tamil Nadu, India.
Pin: 632002 |
|
|
Primary Sponsor
|
| Name |
Christian Medical College Vellore Tamilnadu India |
| Address |
Christian Medical College, Vellore, Tamilnadu, India. Pin: 632002 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devshankar moosad E I |
Christian Medical College, Vellore |
Surgical ICU, Christian Medical College, Vellore Tamilnadu
632002
Vellore
TAMIL NADU |
6282903775
devshankar.moosad@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Christian medical college instituitional Ethic committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adaptive support ventilation |
ASV is an intelligent ventilator mode that automatically adjusts the level of breathing support based on the patients lung condition and effort to promote safe and efficient weaning.
Duration: Till time of extubation, when the patient has got positive spontaneous breathing test (SBT) |
| Comparator Agent |
Pressure support ventialtion |
PSV is a ventilator mode where the patient initiates breaths and the machine provides a fixed pressure boost, manually set by clinicians, to reduce the work of breathing.
Duration: Till time of extubation, when the patient has got positive spontaneous breathing test (SBT) |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Mechanical ventilation for at least 24 hrs
Patients with APACHE II score of 5 - 20
|
|
| ExclusionCriteria |
| Details |
a) Mechanical ventilation for less than 24 hours (including self extubation or death).
b) Patients with Coexisting severe Neurological/ Neuromuscular/Quadriplegia/Critical illness neuropathy/ Critical illness Myopathy/ Myasthenia gravis/ Guillain Barre syndrome or cardiac diseases as it may prolong weaning for extra-pulmonary reasons.
c) Pregnancy
|
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Method of Generating Random Sequence
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Permuted block randomization, variable |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Incidence of successful weaning
|
48 hrs after extubation
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to Successful Extubation, Duration from initiation of weaning to successful extubation.
2. Total Duration of Mechanical Ventilation, Time from intubation to final extubation
3. ICU Length of Stay, Total duration of ICU stay post initiation of weaning.
4. Mortality, ICU mortality rates.
5. Number of manual ventilator aadjustments & ABG sampling required in each group
6. VAP Incidence rate
|
1. baseline & 48hrs after extubation
2. at the time of extubation
3. at the time of discharge
4. at any point of the study after baseline.
5. at the time of extubation
6. at the time of extubation |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/07/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Study Title Comparison of Adaptive Support Ventilation and Pressure Support Ventilation for Weaning and Extubation Outcomes in Critically Ill Patients in an Indian ICU – A Prospective Randomized Study
Study Summary This prospective randomized study compares the effectiveness of Adaptive Support Ventilation ASV and Pressure Support Ventilation PSV in weaning critically ill patients from mechanical ventilation. The study population includes surgical and trauma patients with medical comorbidities. Previous studies have shown different outcomes between medical and surgical ICU patients under similar protocols.
Inclusion Criteria
Age above 18 years
Mechanically ventilated for 24 hours or more
APACHE II score between 5 and 30
Exclusion Criteria
Severe neurological or cardiac conditions
Pregnant women
Patients will be enrolled once their acute illness has resolved and the clinical team decides to start weaning. Consent will be obtained from the next of kin. Randomization will be done using permuted block randomization with concealed allocation through opaque sealed envelopes. Patients will be assigned to either ASV or PSV.
Weaning Criteria
Reversal of initial cause for ventilation
Hemodynamic stability with heart rate less than 120 and respiratory rate less than 35
pH greater than 735, tidal volume more than 5 ml per kg, minute volume less than 10 liters per minute
PEEP less than 5 cm H2O, PaO2 greater than 60 mmHg with FiO2 less than 0.4, and PaO2 to FiO2 ratio greater than 150
A standard ICU extubation protocol will be followed. Patients will be considered for extubation when they meet readiness criteria such as:
Hemodynamic stability with minimal or no vasopressors
Adequate oxygenation with PaO2 to FiO2 ratio above 150 to 200 and SpO2 above 92 percent on 40 percent FiO2 or less
Protective airway reflexes like cough and gag
Adequate mental status and ability to protect airway
Successful completion of a spontaneous breathing trial
All other ICU management including sedation, investigations, and resuscitation will be uniform across both groups. Most extubations will occur between 7 AM and 7 PM due to staff availability and institutional safety protocols. This timing is consistent across both groups and does not introduce bias.
Primary Outcome Successful weaning defined as a composite of:
No need for reintubation within 48 hours
If NIV is needed, HACOR score less than 5
If HFNC is needed, ROX index greater than 285 at 2 hours
Secondary Outcomes
Total duration of mechanical ventilation
Time to successful extubation
ICU length of stay
ICU mortality
Number of manual ventilator adjustments
Number of ABG analyses required
Rate of ventilator associated pneumonia
This study aims to identify the better ventilatory strategy for improving weaning and extubation outcomes in surgical ICU patients.
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