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CTRI Number  CTRI/2026/02/103316 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 06/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to observe the breathing function of patients admitted with serious condition and put on machine support for breathing 
Scientific Title of Study   Prospective insights into diaphragmatic function and weaning outcomes in mechanically ventilated ICU patients: A Point of Care ultrasound approach 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Robin Manidas 
Designation  Senior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of critical care, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, 576104, India

Udupi
KARNATAKA
576104
India 
Phone  9496967774  
Fax    
Email  robin.manidas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sagar M S 
Designation  Additional Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of critical care medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, 576104, India

Udupi
KARNATAKA
576104
India 
Phone  08202922033  
Fax    
Email  sagarmaddani04@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sagar M S 
Designation  Additional Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of critical care medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, 576104, India

Udupi
KARNATAKA
576104
India 
Phone  08202922033  
Fax    
Email  sagarmaddani04@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal academy of higher education, Manipal, Udupi 
 
Primary Sponsor  
Name  Dr Robin Manidas 
Address  Department of critical care medicine, Kasturba Medical College,Manipal Academy of Higher Education, Manipal, 576104 
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 
Dr Robin Manidas  Kasturba hospital, Manipal  Intensive care units 1 and 2, Department of Critical Care Medicine, First floor, New trauma block, Kasturba Hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA 		 9496967774

robin.manidas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J960||Acute respiratory failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients who are admitted to intensive care units and require Invasive mechanical ventilation for greater than 72 hours  
 
ExclusionCriteria 
Details  1.Patient ventilated for less than 72 hours.
2.Consent refusal by patient or next of kin.
3.Pre-existing neuromuscular disorders affecting respiratory muscles.
4.Known diaphragmatic paralysis or prior diaphragmatic surgery/trauma
5.Patients in whom acquisition of reliable diaphragmatic ultrasound images is difficult.
6.Pneumothorax or active large pleural effusion or pregnancy preventing diaphragm assessment. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study is the rate of change in diaphragmatic function over the first five days of mechanical ventilation, assessed by diaphragmatic thickening fraction (TFdi), diaphragmatic excursion and tissue doppler  1. At baseline ( time of initiation of mechanical ventilation)
2. At day 5 of mechanical ventilation  
 
Secondary Outcome  
Outcome  TimePoints 
1. Secondary outcomes include the impact of ventilatory mode (volume-controlled versus pressure-controlled) on diaphragmatic function.
 		 1. At baseline ( time of initiation of mechanical ventilation)
2. At day 5 of mechanical ventilation  
2. The study will also co-relate the diaphragmatic function with changes in peripheral muscle thickness (rectus abdominis, rectus femoris) over Day 5  1. At baseline ( time of initiation of mechanical ventilation)
2. At day 5 of mechanical ventilation  
 
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   N/A 
Date of First Enrollment (India)   20/02/2026 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Study title and design

Prospectie longitudinal obserational study assessing diaphragmatic function using point of care ultrasound in mechanically ventilated adult ICU patients


Objectives

To evaluate serial changes in  diaphragmatic thickness thickening fraction and excursion during the first 5 ICU days
Compare the effects of volume controlled versus pressure controlled ventilation
Study the association between driing pressure and diaphragmatic dysfunction and determine whether early diaphragmatic dysfunction predicts difficult or prolonged weaning


Rationale

Mechanical ventilation is associated with ventilator induced diaphragmaic dysfunction which contritubes to delayed weaning prolonged ICU stay and worse clinical outcomes
There is limited prospective Indian data describing the trajectory of diaphragmatic function during mechanical ventilation and its impact on weaning outcome
This study aims to address this gap and support early risk stratification and optmisation of of ventilator strategies


Participants

Adult patients aged 18 years and above requiring  invasive mechanical ventilation for more than 72  hours with ICU stay atleast 5 days
Patient with pre existing neuromuscular disease diaphramatic pathology technical limitation to ultrasound or refusal of consent will be excluded


Methods

Eligible patients will be enrolled within 24 hours of initiation of mechanical ventilation. Baseline demographic data illness severity score SOFA and APACHE II ventilator parameter laboratory values and nutritional intake will be recorded daily.Daily point of care ultrasound assessments from day 1  to day 5 will include diaphragmatic thickness thickening fraction, excursion tissue doppler indices and peripheral muscle thickness.Weaning outcomes duration of ventilation ICU length of stay and mortality will be documented. No additional interentions or biological sampling will be perfomed.

Outcomes

The primary outcome is the rate of change in diaphragmatic function over the first 5 days of mechanical ventilation
Secondary outcomes include the effect of ventilatory mode and driving pressure on diaphragmatic function prediction of weaning outcomes and  correlation  with  duration of ventilation ICU stay mortality and peripheral muscle  wasting


 
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