| CTRI Number |
CTRI/2023/03/050196 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
25/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to predict non invasive ventilation failure in chronic obstructive pulmonary disease patients using ultrasonographic evaluation of diaphragm |
|
Scientific Title of Study
|
Diaphragmatic ultrasound in predicting non-invasive ventilation failure in chronic obstructive pulmonary disease patients: A prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kanika Chaudhary |
| Designation |
Senior Resident |
| Affiliation |
Max Superspecialty hospital |
| Address |
MICU 2, 2nd floor
Department of Critical Care Medicine
Max Super-speciality Hospital
Mussoorie Diversion Road
Dehradun
Uttarakhand-248001
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8447992368 |
| Fax |
|
| Email |
kanikaten@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shantanu Belwal |
| Designation |
Principle Consultant and Head of Department |
| Affiliation |
Max Superspecialty hospital |
| Address |
MICU2, 2nd floor
Department of Critical Care Medicine
Max Super-speciality Hospital
Mussoorie Diversion Road
Dehradun
Uttarakhand-248001
Dehradun
UTTARANCHAL
248001
India |
| Phone |
919997642020 |
| Fax |
|
| Email |
Belwalster@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanika Chaudhary |
| Designation |
Senior Resident |
| Affiliation |
Max Superspecialty hospital |
| Address |
MICU2, 2nd floor
Department of Critical Care Medicine
Max Super-speciality Hospital
Mussoorie Diversion Road
Dehradun
Uttarakhand-248001
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8447992368 |
| Fax |
|
| Email |
kanikaten@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical ICU
Department of Critical Care Medicine
Max Super speciality Hospital Dehradun |
|
|
Primary Sponsor
|
| Name |
Dr Kanika Chaudhary |
| Address |
MICU2, 2nd floor
Department of Critical Care Medicine
Max Super speciality Hospital
Mussoorie Diversion Road
Dehradun
Uttarakhand-248001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Arjun Lal Poptani |
Max Super specialty Hospital
Mussoorie Diversion Road
Dehradun
Uttarakhand |
| Dr Shantanu Belwal |
Max Super speciality Hospital
Mussoorie Diversion Road
Dehradun
Uttarakhand |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kanika Chaudhary |
Max Supe specialty Hospital, Dehradun |
MICU 2, 2nd floor
Department of Critical Care Medicine
Max Super specialty Hospital
Mussoorie Diversion Road
Dehradun
Uttarakhand-248001
Dehradun
UTTARANCHAL |
8447992368
kanikaten@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Super Speciality Hospital, Dehradun |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
COPD patients of either gender having a respiratory rate> 30 breaths per minute, peripheral oxygen saturation (SpO2) <88% with oxygen therapy through a Venturi mask or Non-Rebreathing Mask and active use of accessory muscles of respiration or paradoxical abdominal breathing. |
|
| ExclusionCriteria |
| Details |
1) Refusal of written informed consent
2) Mentally Retarded patients
3) Shock requiring vasopressors support
4) Acute pulmonary edema
5) Interstitial lung disease
6) Chest wall deformities
7) Previous diaphragmatic palsy
8) Papilledema
9) Pregnancy
10) Obesity (BMI>35 Kg/m2)
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To predict NIV failure
|
Assessment will be done at baseline,6,12 and 24 hours of NIV treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ICU stay, hospital stay and in hospital mortality
|
Secondary outcome will be assessed till 1 month of hospital stay |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/03/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Non-Invasive Ventilation (NIV) failure rates are increasing nowadays in patients admitted with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Sonographic assessment of the diaphragm is a non-invasive method of estimating diaphragmatic excursion (DE), speed of contraction (DC), and diaphragmatic thickness fraction (DTF). With these parameters, we can predict NIV failure and prevent delayed endotracheal intubation but there are limited data summarizing their accuracy across multiple studies. We will be performing a prospective observational study to evaluate the diaphragm using the ultrasonographic measurement of DE, DC, and DTF to predict NIV failure in COPD patients |