| CTRI Number |
CTRI/2020/12/030022 [Registered on: 24/12/2020] Trial Registered Prospectively |
| Last Modified On: |
23/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Difference in diaphragmatic thickness in patients on two type of mechanical ventilation |
|
Scientific Title of Study
|
Comparison of diaphragmatic atrophy in patients on ventilator support with SIMV+PS mode and PRVC mode: A Prospective Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakulprasath S |
| Designation |
Junior resident |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
Department of Anaesthesia and intensive care
Postgraduate institute of medical education and research
Sector 12
Chandigarh
Postgraduate institute of medical education and research
Sector 12
Chandigarh
Pincode : 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9942173629 |
| Fax |
|
| Email |
rakulprasath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
L N Yaddanapudi |
| Designation |
Professor |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
Department of Anaesthesia and intensive care
Postgraduate institute of medical education and research
Sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815836656 |
| Fax |
|
| Email |
narayana.yaddanapudi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
L N Yaddanapudi |
| Designation |
Professor |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
Department of Anaesthesia and intensive care
Postgraduate institute of medical education and research
Sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815836656 |
| Fax |
|
| Email |
narayana.yaddanapudi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate institute of medical education and research
Sector 12
Chandigarh 160012 |
|
|
Primary Sponsor
|
| Name |
Postgraduate institute of medical education and research |
| Address |
Sector 12
Chandigarh
Pincode : 160012
INDIA |
| 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 |
| RAKULPRASATH S |
Postgraduate institute of medical education and research |
Main intensive care unit
Level 2
Postgraduate institute of medical education and research
Chandigarh
CHANDIGARH |
9942173629
rakulprasath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, PGIMER, CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J969||Respiratory failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison between SIMV PS mode and PRVC mode of mechanical ventilation |
Patients will be divided into two groups. One group will be put on SIMV PS mode and another group will be put on PRVC mode of mechanical ventilation.In SIMV PS mode ( Synchronized Intermittent Mandatory Ventilation with Pressure Support ), the ventilator’s assistance is in the form of a fast high flow assistance to a set pressure limit with the time of the end of the support is determined by the patient’s lung characteristics. PRVC ( Pressure Regulated Volume Control ) mode is volume targeted, pressure control mode where patient or time triggered time cycled breaths are delivered by the ventilator. |
| Intervention |
Mode of mechanical ventilation |
Patients will be divided into two groups. One group of patient will be put on SIMV PS mode and another group will be put on PRVC mode of mechanical ventilation. In SIMV PS mode ( Synchronized Intermittent Mandatory Ventilation with Pressure Support ), the ventilator’s assistance is in the form of a fast high flow assistance to a set pressure limit with the time of the end of the support is determined by the patient’s lung characteristics. PRVC ( Pressure Regulated Volume Control ) mode is volume targeted, pressure control mode where patient or time triggered time cycled breaths are delivered by the ventilator. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring mechanical ventilation in the Intensive Care Unit |
|
| ExclusionCriteria |
| Details |
1.Mechanical ventilation before coming into Intensive Care Unit
2.Patients who are not started on enteral feeding within 24 hours of coming into Intensive Care Unit
3.Patients with neuromuscular disorders and anatomical malformation of the thorax
4.Patients with neuroparalytic snake bite
5.Patients with spinal and brachial plexus injury
6.Patients with organophosphorus poisoning
7.Usage of neuromuscular blockers during mechanical ventilation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diaphragmatic atrophy in terms of diaphragm muscle thickness |
One measurement taken within 6 hours of initiation of mechanical ventilation and another measurement done at 72 hours of mechanical ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Days of mechanical ventilation
|
At the time of discontinuing the mechanical ventilation for the patient |
| Days of stay in intensive care unit |
At the time of discharge of the patient from the intensive care unit |
| Weaning Failure |
At the time of starting to wean the patient |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/12/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Mechanical ventilation which is assisting or replacing spontaneous breathing, is used in patients who are unable to maintain life with spontaneous ventilation. It is one of the most commonly used life supportive therapies in Intensive Care Unit. The main objectives of mechanical ventilation are supporting or manipulating pulmonary gas exchange, preventing and treating atelectasis, restoring and maintaining adequate functional residual capacity and reducing work of breathing. It causes respiratory muscle atrophy, particularly of the diaphragm, which is the main respiratory muscle accounting for 60-80% of the inspiratory work. This diaphragm muscle atrophy is due to its under usage during mechanical ventilation and it starts as early s 12-18 hours after initiation of mechanical ventilation and the maximal decrease happens by 72 hours after which there is no further significant damage. Studies have found that diaphragmatic atrophy is associated with duration and mode of ventilation. Ventilator modes can be classified as controlled, assist, pressure support and dual modes. The patient’s respiration is fully supported by the controlled modes of ventilation. There is an increase in protease activity in the respiratory muscles, particularly the diaphragm which in turn will cause atrophy. Assist modes in which the ventilator provides partial support to the patient’s respiratory efforts, may lead to decreased diaphragmatic atrophy. Newer modes of ventilation are designed to allow spontaneous respiration during any part of the ventilatory cycle with assistance to each spontaneous breath. Thus the respiratory muscles including diaphragm are not completely unloaded. Here we are going to compare SIMV PS mode and PRVC mode of ventilation to find out which mode causes less diaphragmatic atrophy. In SIMV PS mode ( Synchronized Intermittent Mandatory Ventilation with Pressure Support ), the ventilator’s assistance is in the form of a fast high flow assistance to a set pressure limit with the time of the end of the support is determined by the patient’s lung characteristics. PRVC ( Pressure Regulated Volume Control ) mode is volume targeted, pressure control mode where patient or time triggered time cycled breaths are delivered by the ventilator. It combines the advantages of both volume controlled and pressure controlled modes of ventilation. There are direct and indirect methods of assessing diaphragm muscle thickness. Ultrasonography is being used as the main entity for the diaphragmatic assessment as it is portable and non invasive method. Here the patients will be randomly allocated into two groups by computer generated random number chart. the concealment of allocation is achieved by telephonic allocation. Once randomized, intensivist taking USG measurements will not be blinded. The statistician will be blinded to the two groups. Before starting the study baseline parameters like demographic data, anthropometric data and history of any comorbid illness is noted down. The diaphragm thickness will be measured using ultrasonography. First reading will be taken within 6 hours of initiation of mechanical ventilation as baseline recordings. Second reading will be taken at 72 hours after initiation of mechanical ventilation. Both these recordings will be taken by same physician. Thickness of the diaphragm will be measured with straight probe at zone of transition on the mid axillary line at the liver window on the right and the spleen window on the left side. Three measurements will be taken and the average of them will be taken as a reading. Nutritional status may act as a confounding factor, which can be reduced by starting the enteral feeds within 24 hours of ICU admission. The quadriceps muscle thickness measurements are taken which acts as control. The other possible confounding factor is the swelling of the diaphragm due to inflammation which can be assessed by serum procalcitonin levels at 72 hours in both groups. Here, we hypothesize that PRVC mode of ventilation causes less diaphragmatic atrophy than SIMV PS mode. In this study we plan to compare the extent of diaphragmatic atrophy in mechanically ventilated patients caused by these two modes. |