| CTRI Number |
CTRI/2024/11/077146 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of Non-Invasive Ventilation on Chest Ultrasound Findings in Patients with Acute Respiratory Failure and its link to Ventilation Success or Failure |
|
Scientific Title of Study
|
Study of Respiratory Mechanics using Ultrasound in Acute Respiratory Failure before and after Non-Invasive Ventilation |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Gupta |
| Designation |
DrNB student |
| Affiliation |
Artemis Hospitals Gurugram |
| Address |
Departement of Critical Care unit II, Artemis Hospitals, Sector 51, Gurugram, Haryana, India
Gurgaon
HARYANA
122001
India |
| Phone |
|
| Fax |
|
| Email |
ashishg19995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kuldeep Singh |
| Designation |
Associate chief |
| Affiliation |
Artemis Hospitals Gurugram |
| Address |
Departement of Critical Care unit II, Artemis Hospitals, Sector 51, Gurugram, Haryana, India
Gurgaon
HARYANA
122001
India |
| Phone |
01244511111 |
| Fax |
|
| Email |
kuldeep@artemishospitals.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kuldeep Singh |
| Designation |
Associate chief |
| Affiliation |
Artemis Hospitals Gurugram |
| Address |
Departement of Critical Care unit II, Artemis Hospitals, Sector 51, Gurugram, Haryana, India
HARYANA
122001
India |
| Phone |
01244511111 |
| Fax |
|
| Email |
kuldeep@artemishospitals.com |
|
|
Source of Monetary or Material Support
|
| Departemnt of Critical Care, Artemis Hospitals, Sector 51, Gurugram 122001
Haryana, India |
|
|
Primary Sponsor
|
| Name |
Dr Ashish Gupta |
| Address |
Departement of Critical Care, Artemis Hospitals, Sector 51, Gurugram 122001
Haryana, India |
| 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 |
| Dr Ashish Gupta |
Artemis Hospitals |
Department of Critical Care-Unit II, second floor, Artemis Hospitals, Sector 51, Gurugram 122001
Haryana, India
Gurgaon
HARYANA |
8683054779
ashishg19995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Artemis Health Sciences IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J960||Acute respiratory failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted in Intensive Care Unit (ICU) with
1. Acute respiratory failure
2. PaO2/FiO2 less than 300
3. Including Type I Respiratory Failure, Type II Respiratory Failure and patients with increased work of breathing, and
4. scheduled for NIV trial |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Age less than 18 years
3. All contraindications to NIV
4. Non-compliance to NIV
5. Patients on domiciliary NIV support
6. Patients with chest wall deformity
7. Patients with recent history of chest or abdominal surgery (within 1 month)
8. Any structural change in chest and abdomen ultrasound which confound the ultrasound parameters
9. Poor echogenic window
10. Obesity (BMI more than 35kg per m2)
11. Pregnant patients
12. Patients with pre-existing Diaphragm paralysis
13. Patients with pre-existing Neuromuscular disorders
14. Patients with history of diaphragm surgery
15. Patients who refused for invasive mechanical ventilation
16. Patients requiring planed intubation for any procedure or surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in lung ultrasound score, diaphragm excursion, diaphragm thickening fraction, parasternal intercostal muscle thickening fraction, and expiratory abdominal muscle thickening fraction after institution of NIV. Association of these parameters with NIV failure. |
Baseline
6,12,24,48 hours after initiation on NIV |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of above mentioned ultrasound parameters with ICU stay duration, hospital stay duration and ICU and in-hospital mortality. |
Baseline
6,12,24,48 hours after initiation on NIV, till discahrge of the patient |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
05/12/2024 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study title: Study of Respiratory Mechanics using Ultrasound in
Acute Respiratory Failure before and after Non-Invasive Ventilation
Study Aim: The aim is to study the respiratory mechanics using ultrasound
in patients with Acute Respiratory Failure before and after institution of Non-Invasive
Ventilation.
Study Design: Prospective, observational single centre study
Study Area: Intensive Care Unit, Artemis Hospitals, Gurgaon; a
tertiary care centre
Study Duration: 18 months
Sample size: 65 patients
Inclusion criteria: Patients admitted in Intensive Care Unit (ICU) with
acute respiratory failure (PaO2/FiO2 <300), including Type I Respiratory
Failure, Type II Respiratory Failure and patients with increased work of
breathing, and scheduled for Non-invasive ventilation (NIV) trial.
Exclusion criteria: Patient refusal, Age less than 18 years, all
contraindications to NIV, Non-compliance to NIV, patients on domiciliary NIV
support, patients with chest wall deformity, patients with recent history of
chest or abdominal surgery (within 1 month), any structural change in chest and
abdomen ultrasound which confound the ultrasound parameters, poor echogenic
window, obesity (BMI> 35kg/m2), pregnant patients, patients with
pre-existing Diaphragm paralysis, patients with pre-existing Neuromuscular
disorders, patients with history of diaphragm surgery, patients who refused for
invasive mechanical ventilation, and patients requiring planed intubation for
any procedure or surgery.
Parameters to be measured: Respiratory parameters (respiratory rate, use of
accessory muscles), Hemodynamic parameters (Heart rate, Blood pressure, Oxygen
saturation), Arterial blood analysis parameters (partial pressure of
oxygen-PaO2, partial pressure of carbon dioxide-PaCO2, fraction of inspired
oxygen-FiO2, bicarbonate levels, PaO2/FiO2 ratio), Ultrasound parameters (lung
ultrasound score, diaphragm excursion, diaphragm thickening fraction,
parasternal intercostal muscle thickening fraction, and expiratory abdominal
muscle thickening fraction), and Ventilator parameters
(FiO2, PEEP, PS over PEEP, Ppeak) at
baseline, and at 6,12,24,48 hours.
Outcome measures: Changes in lung ultrasound score, diaphragm excursion,
diaphragm thickening fraction, parasternal intercostal muscle thickening
fraction, and expiratory abdominal muscle thickening fraction after institution
of NIV. Association of these parameters with NIV failure, ICU stay duration,
hospital stay duration and ICU & in-hospital mortality.
Statistical
analysis: The data will be
entered in Microsoft Excel and statistical analysis will be done using
Statistical Package for Social Sciences (SPSS) software version version 23 (IBM
Corp.). Appropriate statistical tests will be applied according to the nature
of the data. P value <0.05 will be considered as statistically significant
|