| CTRI Number |
CTRI/2020/05/025462 [Registered on: 29/05/2020] Trial Registered Prospectively |
| Last Modified On: |
20/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Outcome assesor blinded |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using Ultrasound to detect diaphragm dysfunction in patients with acute deterioration of chronic obstructive lung disease and assessing its utility in estimating failure of Non invasive ventilation in such patients |
|
Scientific Title of Study
|
Utility of Ultrasound-assessed diaphragmatic dysfunction in estimating non-invasive ventilation failure of patients with Acute exacerbation of chronic obstructive pulmonary disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nupur B Patel |
| Designation |
SR Acedemic |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department of Anaesthesiology AIIMS RISHIKESH Virbhadra Marg
Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8489926988 |
| Fax |
|
| Email |
nupurbpatel@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Jain |
| Designation |
Associate Professor |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department of Anaesthesiology AIIMS RISHIKESH Virbhadra Marg
Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8808631209 |
| Fax |
|
| Email |
gauravhld@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Jain |
| Designation |
Associate Professor |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department of Anaesthesiology AIIMS RISHIKESH Virbhadra Marg
Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8808631209 |
| Fax |
|
| Email |
gauravhld@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology AIIMS Rishikesh |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Nupur B Patel |
Critical Care Unit |
Level 06,
Department of
Anesthesiology AIIMS
Rishikesh Virbhadra
Marg Rishikesh
Dehradun
UTTARANCHAL |
8489926988
nupurbpatel@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee AIIMS, Rishikesh. |
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
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Acute exacerbation of chronic obstructive lung disease with acidosis (PaCO2 >45mm Hg, pH <7.25) in need of non-invasive ventilation |
|
| ExclusionCriteria |
| Details |
1. Patients with acute pulmonary edema.
2. History of interstitial lung disease.
3. History of neuromuscular disease.
4. Chest wall deformities.
5. Previously diagnosed diaphragmatic palsy.
6. Hemodynamic instability (Systolic blood pressure <90 mm Hg).
7. Intracranial hypertension.
8. Pregnancy.
9. Any contraindication to Non-invasive ventilation,
10. Need for immediate endotracheal intubation or invasive mechanical ventilation at ICU admission
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Non-invasive ventilation (NIV) failure rate with respect to new onset or continuous diaphragmatic dysfunction assessed by ultrasound guided measurement of change in diaphragmatic thickness (ΔTDI). |
ΔTDI assessed at 2 hrs on NIV or immediately prior to intubation if patient requires intubation before 2 hrs of NIV.
NIV failure assessed during ICU stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Diaphragmatic dysfunction assessed by ultrasound guided measurement of change in diaphragmatic thickness (ΔTDI). |
At ICU admission |
| Time to NIV failure. |
ICU admission (Day 1) to time point of intubation. |
| Ventilation days (Non - invasive). |
Duration of non-invasive ventilation |
| Ventilation days (invasive). |
Duration of invasive ventilation |
| Length of stay in ICU. |
ICU admission ( Day 1) to patients ICU discharge or death or 30 days whichever is earlier |
| In hospital length of stay. |
ICU admission (Day 1) to patient discharge or death or 30 days whichever is earlier. |
| ICU mortality, In hospital mortality and 30 day mortality. |
ICU admission (Day 1) to 30 days follow up or death whichever is earlier. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/06/2020 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is defined as an acute event characterized by a worsening of the patient’s respiratory symptoms. Noninvasive (NIV) is the first-line management in AECOPD. Diaphragmatic dysfunction (DD) is a common reason for dyspnoea in COPD. Ultrasound is a cheap, safe, non-invasive, less time consuming, bedside tool for detecting DD. Among various USG parameters, change in the diaphragmatic thickness (ΔTDI) has been found to be the most sensitive parameter of DD. The aim of our study will be to assess the utility of ultrasound assessed DD (continuous and new-onset) in estimating the NIV failure of patients with AECOPD. |