| CTRI Number |
CTRI/2025/12/099945 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two methods of adjusting breathing machine support in ICU patients with respiratory problems, to understand which leads to better weaning off process and thus better outcome |
|
Scientific Title of Study
|
To Compare Pressure Support Adjustments Using Diaphragmatic Thickness Fraction And Conventional Method In Patients With Respiratory Distress On Mechanical Ventilation Admitted In ICU: A Randomized Controlled 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 |
Dr Prashant Kumar Mishra |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh university of medical sciences |
| Address |
Room number 329, third floor Old OPD Building, Department of Anesthesiology and critical care.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9455677608 |
| Fax |
|
| Email |
drprashant.mishra@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Kumar Mishra |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh university of medical sciences |
| Address |
Room number 329, third floor Old OPD Building, Department of Anesthesiology and critical care.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9455677608 |
| Fax |
|
| Email |
drprashant.mishra@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant Kumar Mishra |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh university of medical sciences |
| Address |
Room number 329, third floor Old OPD Building, Department of Anesthesiology and critical care.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9455677608 |
| Fax |
|
| Email |
drprashant.mishra@yahoo.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University of Medical Sciences |
| Address |
Room 329, Department of Anaesthesiology, Uttar Pradesh University of Medical Sciences.
Saifai, Etawah.
Uttar Pradesh
206130 |
| 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 |
| Priyanka Yadav |
Uttar Pradesh University of Medical Sciences |
ROOM NO. 329, Department of anesthesiology and Critical care, Uttar Pradesh University of Medical Sciences, Saifai.
Etawah
UTTAR PRADESH |
09627580717
dr.pixy717@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Uttar Pradesh University of Medical Sciences |
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: C710||Malignant neoplasm of cerebrum, except lobes and ventricles, (2) ICD-10 Condition: S064||Epidural hemorrhage, (3) ICD-10 Condition: S065||Traumatic subdural hemorrhage, (4) ICD-10 Condition: S398||Other specified injuries of abdomen, lower back, pelvis and external genitals, (5) ICD-10 Condition: O152||Eclampsia complicating the puerperium, (6) ICD-10 Condition: D649||Anemia, unspecified, (7) ICD-10 Condition: K564||Other impaction of intestine, (8) ICD-10 Condition: K565||Intestinal adhesions [bands] withobstruction (postinfection), (9) ICD-10 Condition: K403||Unilateral inguinal hernia, with obstruction, without gangrene, (10) ICD-10 Condition: N179||Acute kidney failure, unspecified, (11) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
changing setting of the ventilator based on two different methods |
Adjusting pressure support setting of the ventilators in two groups of patients, at 0min, 15min, 30min, 45min, 60min, 75min, 90min, 105min, 120min guided by rapid shallow breathing index in one group and diaphragmatic thickness fraction in another group in patients with respiratory distress in ICU. |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients (18-60 years) on pressure support mechanical ventilation in ICU.
2. Respiratory distress using RDOS (Respiratory Distress Observational scale) more than 3 (corresponding with DTF less than 30 and RSBI more than 105 as per previous studies).
3. Post operative & Trauma patients needing elective ventilation
|
|
| ExclusionCriteria |
| Details |
1. Patients with acute or chronic lung pathology.
2. Patients having neuromuscular disorder.
3. Cardiac arrest or hemodynamic instability.
4. Transfer to another ward or hospital during study.
5. Withdrawal of consent or inability to complete study protocol.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study aims to compare Pressure support adjustments using Diaphragmatic Thickness Fraction and Conventional Methods in Patients with Respiratory Distress on Mechanical Ventilation admitted in ICU |
measure starts as soon as the patient enters the icu and taken on mechanical ventilation which is taken as 0min then 15min, 30min, 45min, 60min, 75min, 90min, 105min, 120min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the patient ventilator synchrony in both the groups.
2. To compare earliest time taken to achieve relief from respiratory distress in both the groups.
3. To compare hemodynamic parameters in both the groups.
4. To see the feasibility & reproducibility of implementing DTF-guided pressure support adjustments in routine clinical practice compared to conventional method
|
Measurement will begin from the point patient is admitted in the icu & put on mechanical ventilation 0min then 15min, 30min, 45min, 60min, 75min, 90min, 105min, 120min. |
|
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Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
10/01/2026 |
| 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="0"
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
|
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Brief Summary
|
Title
To Compare Pressure Support Adjustments Using Diaphragmatic Thickness Fraction and Conventional Methods in Patients with Respiratory Distress on Mechanical Ventilation Admitted in ICU A Randomized Controlled Trial
Introduction
Respiratory distress requiring mechanical ventilation is common in ICUs. Proper adjustment of pressure support is vital to prevent diaphragmatic atrophy from over assistance and muscle fatigue or ventilator asynchrony from under assistance. Conventional adjustments use parameters like tidal volume and respiratory rate which may not accurately reflect diaphragm function. Diaphragmatic Thickness Fraction DTF measured by ultrasound can indicate diaphragm activity and may help in more precise adjustments. This study will compare DTF guided and conventional RSBI guided methods for pressure support adjustment to improve patient outcomes.
Review of Literature
Barati et al 2021 compared RSBI guided and tidal volume with respiratory rate guided pressure support adjustment in ICU patients with respiratory distress. RSBI guidance provided faster symptom improvement though final outcomes were similar. Evidence on using diaphragmatic ultrasound for guiding ventilation is limited.
Aim
To compare pressure support adjustments using DTF and conventional methods in mechanically ventilated ICU patients with respiratory distress.
Objectives
Primary To compare DTF guided and RSBI guided pressure support adjustments
Secondary To compare patient ventilator synchrony time to relief of distress hemodynamic parameters and feasibility of using DTF in routine ICU practice
Justification
Pressure support in ventilated patients is often adjusted empirically. DTF offers a direct noninvasive assessment of diaphragm function which may allow more individualized and accurate ventilator settings improving comfort and recovery.
Methodology
A prospective randomized controlled trial will be conducted in ICU after ethics approval and CTRI registration. Adult patients aged 18 to 60 years with respiratory distress requiring mechanical ventilation and RDOS score above 3 will be included. Patients with neuromuscular disease diaphragmatic paralysis or hemodynamic instability will be excluded. Participants will be randomized into two groups using sealed envelope method.
Group A Conventional RSBI guided Pressure Support Adjustment
RSBI will be measured every 15 minutes for 2 hours and pressure support adjusted to maintain RSBI at or below 105.
Group B DTF guided Pressure Support Adjustment
Diaphragm thickness will be measured using ultrasound at end expiration and end inspiration. DTF will be calculated and measured every 15 minutes for 2 hours. Pressure support will be adjusted to maintain DTF at or above 30 percent.
Outcome Variables
Independent variable method of pressure support adjustment
Dependent variables DTF RSBI ventilator synchrony time to relief of distress and hemodynamic parameters
Expected Outcome
DTF guided adjustment is expected to improve patient ventilator synchrony provide faster relief of respiratory distress and offer a more physiologic and feasible approach to individualized ventilator management in ICU patients. |