| CTRI Number |
CTRI/2025/10/095695 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study comparing two methods of measuring breathing effort in patients to find the more accurate approach |
|
Scientific Title of Study
|
Comparison and correlation between occlusion pressure with diaphraghmatic thickening fraction versus occlusion pressure with diaphraghmatic excursion in predicting successful extubation in critically ill patients - A Randomized clinical 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 |
Dr Sathya Narayanan K |
| Designation |
DM Critical care medicine , senior resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Critical Care Medicine, Bangalore, India
Bangalore
India
Bangalore
KARNATAKA
560022
India |
| Phone |
09597447444 |
| Fax |
|
| Email |
sathyavaan4444@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIJAYA KUMAR |
| Designation |
Professor and Head incharge , Department of critical care medicine |
| Affiliation |
Bangalore Medical College and Research Institute, Bangalore - BANGALORE |
| Address |
Department of Critical Care Medicine , 5th floor , Trauma and emergency care centre , Bangalore Medical College
Bangalore
Bangalore
KARNATAKA
560022
India |
| Phone |
09597447444 |
| Fax |
|
| Email |
viji2751977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sathya Narayanan K |
| Designation |
DM Critical care medicine , senior resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Critical Care Medicine, Bangalore, India
Bangalore
Bangalore
KARNATAKA
560022
India |
| Phone |
09597447444 |
| Fax |
|
| Email |
sathyavaan4444@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college & Research institute, Karnataka ,India pin code - 560022 |
|
|
Primary Sponsor
|
| Name |
Department of Critical Care Medicine |
| Address |
5th floor , Trauma and emergency care centre , Bangalore Medical College , BMCRI , Bangalore , Karnataka, India - 560022 |
| 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 |
| DrSathya NarayananK |
Bangalore Medical College & Research Institute |
Department of Critical Care Medicine , 5th floor , Trauma and emergency care centre , Bangalore Medical College, Fort, K.R. Road, Bangalore, Karnataka, India · 560 002 · Krishna Rajendra Road
Bangalore
KARNATAKA |
09597447444
dr.satnark@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Bangalore Medical College & Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diaphraghmatic USG |
Ultrasound of the diaphragm is a non-invasive, straightforward procedure that is highly reproducible in the same individuals. As a result of its extensive usage, several criteria for diaphragmatic ultrasonography have been defined, including diaphragm excursion (DE) and diaphragm thickening fraction (DTF)[4]. Bedside assessment of the measurements of diaphragm thickening during inspiration (i.e, thickening fraction ) with ultrasound, can be used to assess the inspiratory efforts during respiration.The duration of diaphraghmatic usg is 5 to 10 minutes It correlates with the diaphragmatic pressure-time product(PTP) and can be considered as a low cost, noninvasive method for the evaluation of respiratory |
| Intervention |
OCCLUSION PRESSURE |
P0.1(Airway occlusion pressure) is the static pressure generated by all inspiratory muscles against an occluded airway at 0.1s after the onset of inspiration. It is independent of any mechanical load, and it is independant of respiratory system mechanics[1]. P0.1in spontaneous breathing is reliable even in cases of critical illness myopathy of the respiratory muscles. In healthy adults the normal values are in the range of 0.5 to 1.5 cm H2O.The total duration of each intervention is 0.1 second to 1 second. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients willing to give consent
Respiratory failure with mechanical ventilation more than 24 hours
The ability to tolerate spontaneous breathing trial for more than 1 hour |
|
| ExclusionCriteria |
| Details |
1. Neuromuscular diseases or
2.Diaphragmatic paralysis and
3.Tracheostomized patients.
4.Recent thoracoabdominal surgeries,
5.Morbidly obese patients,
6.Hemodynamically unstable patients,
7.Hhigh positive end expiratory pressure (PEEP) and intrinsic PEEP.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation between the diaphragmatic thickness fraction , Diaphraghmatic excursion and P0.1 in the assessment of patients’ contribution in mechanical ventilation. |
0,12,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Extubation success, duration of mechanical ventilation, length of ICU and hospital stays. |
days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
23/10/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sathyavaan4444@gmail.com].
- For how long will this data be available start date provided 15-10-2025 and end date provided 25-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
|
P0.1(Airway occlusion pressure) is the
static pressure generated by all inspiratory muscles against an occluded
airway at 0.1s after the onset of inspiration. It is independent of any
mechanical load, and it is independant of respiratory system mechanics[1].
P0.1in spontaneous breathing is reliable even in cases of critical illness
myopathy of the respiratory muscles. In healthy adults the
normal values are in the range of 0.5 to 1.5 cm H2O. In COPD , it ranges from 2-5 cm H2O. Any
value above 3.5 cm H2O in mechanically ventilated patients is considered as
increased respiratory muscle effort. Values of 3 to 6 cm H2O are recorded
among patients undergoing ventilation for ARDS, whereas values as high as 13
cmH2O have been recorded during weaning. Its limitations are it may
dissociate from the actual respiratory drive in case of auto peep,
nonintubated patients, and it may also vary based on the algorithm used to
calculate the p0.1. Ultrasound of the diaphragm is a
non-invasive, straightforward procedure that is highly reproducible in the
same individuals. As a result of its extensive usage, several criteria for
diaphragmatic ultrasonography have been defined, including diaphragm excursion
(DE) and diaphragm thickening fraction (DTF). Bedside
assessment of the measurements of diaphragm thickening during inspiration
(i.e, thickening fraction ) with ultrasound, can be used to assess the
inspiratory efforts during respiration. It correlates with the diaphragmatic
pressure-time product(PTP) and can be considered as a low cost, noninvasive
method for the evaluation of respiratory drive.
The existing few literature comparing P0.1
with diaphragmatic USG have been done without randomization. To various
biases and confounding factors, we will be doing this study by randomization
and blinding.
|
|