| CTRI Number |
CTRI/2017/11/010621 [Registered on: 23/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
23/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Measurement of decrease in thickness of diaphragm in patients on artificial ventilation |
|
Scientific Title of Study
|
Comparison of diaphragmatic atrophy in patients on ventilatory support with SIMV plus PS mode and ACMV 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 |
Lakshminarayana Yaddanapudi |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Dept. of Anaesthesia and Intensive Care
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815836656 |
| Fax |
|
| Email |
narayana.yaddanapudi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nishanth Raghuram |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Dept. of Anaesthesia and Intensive Care
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
trnishanthpgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lakshminarayana Yaddanapudi |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Dept. of Anaesthesia and Intensive Care
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815836656 |
| Fax |
|
| Email |
narayana.yaddanapudi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lakshminarayana Yaddanapudi |
| Address |
Dept. of Anaesthesia and Intensive Care
PGIMER
Chandigarh |
| Type of Sponsor |
Other [The main supervisor of the thesis] |
|
|
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 |
| Lakshminarayana Yaddanapudi |
PGIMER |
MICU,
Level 1
Nehru Hospital, PGIMER
Sector 12
Chandigarh
CHANDIGARH |
9815836656
narayana.yaddanapudi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Critically ill patients admitted to the ICU requiring mechanical ventilatory support , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ACMV |
Mechanical ventilation using Assist-Control mode |
| Intervention |
SIMV with PS |
Mechanical ventilation using SIMV mode with pressure support |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients requiring mechanical ventilation after admission to ICU |
|
| ExclusionCriteria |
| Details |
1. Mechanical ventilation (invasive and noninvasive) before coming into ICU
2. Patients who are not started on enteral feeding within 24 hours of coming into ICU
3. Patients with known neuromuscular disorders and anatomical malformations of the thorax
4. Patients with neuroparalytic snake bite
5. Patients with organophosphorous compound poisoning
6. Usage of neuromuscular blockers during ventilation
7. Pregnancy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in diaphragmatic thickness measured by ultrasound |
1st day of ventilation
3rd day of ventilation (72 hours after the first measurement) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of ventilation |
At the time of transfer from the ICU |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
02/05/2017 |
| 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) |
Open to Recruitment |
|
Publication Details
|
No publication as yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients receiving mechanical ventilation in the ICU suffer from diaphragmatic atrophy, which is usually maximal by the third day of ventilation. This atrophy can pose problems in weaning of the patient from ventilation. Synchronised Intermittent Mandatory Ventilation with Pressure Support and Assist-Control Mechanical Ventilation are two comon modes of ventilation in critically ill patients. This study aims to quantify and compare the degree of atrophy with these two modes of ventilation.
|