| CTRI Number |
CTRI/2020/11/028895 [Registered on: 04/11/2020] Trial Registered Prospectively |
| Last Modified On: |
27/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasound assessment of expiratory muscle dysfunction |
|
Scientific Title of Study
|
Assessment of expiratory muscle dysfunction in critically ill patients using abdominal ultrasound and association with basal lung atelectasis, diaphragmatic excursion and weaning success – a cross-sectional study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vedaghosh Amara |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College and Hospital. |
| Address |
Department of Critical Care, First Floor, Trauma and Emergency Block, Kasturba Medical College and Hospital,Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
vedaghosh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vedaghosh Amara |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College and Hospital. |
| Address |
Department of Critical Care, First Floor, Trauma and Emergency Block
Kasturba Medical College and Hospital,Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
vedaghosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vedaghosh Amara |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College and Hospital. |
| Address |
Department of Critical Care, First Floor, Trauma and Emergency Block,
Kasturba Medical College and Hospital,Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
vedaghosh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Madhav Nagar, Manipal, Udupi District, Karnataka PIN-576104 |
|
|
Primary Sponsor
|
| Name |
Vedaghosh Amara |
| Address |
Kasturba Medical College and Hospital,Madhav Nagar,Manipal,Karnataka. |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Vedaghosh Amara |
Department of Critical Care |
ICU 1, ICU 2, ICU 3, MM7, First Floor, trauma and Emergency Block, Department of Critical Care, Kasturba Medical College and Hospital,Madhav Nagar,Manipal.
Udupi
KARNATAKA |
9985087798
vedaghosh@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients on Oxygen Support with either invasive ventilation or Non Invasive ventilation |
|
| ExclusionCriteria |
| Details |
(i) Patients with abdominal trauma causing damage to the abdominal wall and distortion of the anatomy.
(ii) Patients with localized fluid collections, hernias (ventral hernias, Spigelian hernias, incisional hernia, femoral hernia, endometriosis, abdominal wall hematoma, inguinal masses.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of expiratory muscle function, diaphragmatic excursion and basal lung atelectasis with ultrasound during the course of intensive care stay. |
time to spontaneous breathing trial either success or failure or 7 days whichever is earlier. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| outcome of icu stay |
28 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
16/11/2020 |
| 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
|
Expiratory muscles are an important component of respiratory function and muscle pump, especially in critically ill patients. But, it is often neglected by the clinician, who focuses mostly on the inspiratory muscles like diaphragm. The expiratory muscle which are crucial for successful weaning from ventilatory support are rectus abdominis, internal oblique, external oblique and transverse abdominis muscles. The thickness of these muscles should follow a particular order for us to ensure that expiratory muscles are functioning properly. The order of thickness is rectus abdominis>internal oblique>external oblique>transverse abdominis. We aim to analyze this muscle thickness pattern using bedside ultrasound in ICU patients whenever they are being weaned from either non-invasive ventilation or invasive ventilation. So, we will be performing the bedside ultrasound on those weaning days, and we will record the expiratory muscle thickness order , lung ultrasound findings and even the inspiratory muscle (diaphragmatic) excursion. We will correlate these findings to assess whether this has a positive predictive value in spontaneous breathing success. If a correlation is found, the expiratory muscle ultrasound can form a part of future weaning protocols and criteria. We are prospectively going to recruit 80 patients with the given inclusion and exclusion criteria for the study over a period of one year |