| CTRI Number |
CTRI/2024/08/072659 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of How Adjusted Mechanical Power of respiratory system Helps Predict weaning from mechanical ventilation in Patients with severe respiratory infection . |
|
Scientific Title of Study
|
Evaluation of the role of mechanical power normalised for static compliance in predicting weaning outcome of patients receiving invasive mechanical ventilation for acute respiratory distress syndrome. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishnavi Pandith |
| Designation |
Senior resident |
| Affiliation |
All India institute of medical sciences |
| Address |
Department of anaesthesiology and critical care All India institute of medical sciences,Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9731182158 |
| Fax |
|
| Email |
vaishnavipandith@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Agarwal |
| Designation |
Associate professor |
| Affiliation |
All India institute of medical sciences |
| Address |
Department of Anaesthesiology and critical care All India institute of medical sciences Rishikesh
UTTARANCHAL
249203
India |
| Phone |
9731182158 |
| Fax |
|
| Email |
ankit.anaes@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishnavi Pandith |
| Designation |
Senior resident |
| Affiliation |
All India institute of medical sciences |
| Address |
Department of Anaesthesiology and critical care All India institute of medical sciences Rishikesh
UTTARANCHAL
249203
India |
| Phone |
9731182158 |
| Fax |
|
| Email |
vaishnavipandith@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of medical science Rishikesh |
|
|
Primary Sponsor
|
| Name |
All India institute of medical sciences Rishikesh |
| Address |
All India of medical sciences Rishikesh, Uttarakhand-249203 |
| Type of Sponsor |
Research institution |
|
|
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 Vaishnavi Pandith |
AIIMS Rishikesh |
Department of anaesthesiology and critical care All India institute of medical sciences Rishikesh Rishikesh,Uttarakhand-249203
Dehradun
UTTARANCHAL |
9731182158
vaishnavipandith@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Aiims Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
None
Observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion |
|
| ExclusionCriteria |
| Details |
Pregnancy 2. History of neuromuscular disease 3. Chest wall deformities 4. Intracranial hypertension 5. Refusal to consent. 6. Need of mechanical ventilation less than 24hr hours 7. Required long term ventilation within 3 months. 8. Associated Interstitial lung disease 9. Congestive cardiac failure 10. Patients with poor Sensorium 11. Patients with known history of copd 12. Patients with known history of asthma 13. Hemodynamically unstable |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of mechanical power normalised to static compliance in predicting weaning failure in patients with acute respiratory distress syndrome. |
To be measured 24 hours before weaning trial and to assess need of ventilatory support till 48 hours after weaning |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of mechanical power normalised to Alveolar arterial gradient in predicting weaning failure in patients with acute respiratory distress syndrome. |
24hrs before weaning |
| To evaluate the value static compliance as a weaning predictor in patients with acute respiratory distress syndrome. |
24 hrs before weaning |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
30/09/2024 |
| 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="0"
Months="8"
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
|
Patients satisfying clinical criteria for ARDS according to Berlin definition will be included. At baseline, patients will be maintained deeply sedated and paralysed, ventilated in volume control with a square wave form without any inspiratory pause, applying a tidal volume between 4-6 mL/kg of ideal body weight with a PEEP value and FiO2 set by the attending physician to ensure an arterial saturation between 93 and 97%. At baseline, data will be collected including age, sex, body mass index, Simplified Acute Physiology Score (SAPS II), cause for ARDS, PaO2/FiO2, PaCO2, and clinical mechanical ventilator setting (PEEP, respiratory rate, tidal volume). ARDS patients will be classified as mild (200 mmHg < PaO2/FiO2 ratio ≤ 300 mmHg), moderate (100 mmHg < PaO2/FiO2 ratio ≤ 200 mmHg), or severe (PaO2/FiO2 ratio ≤ 100 mmHg) according to the Berlin definition . Once the patients clinical condition improves is considered ready to wean ,under deep sedation the variables determining the mechanical power and plateau pressure will be recorded. There after the sedation is stopped and gradual reduction in the mechanical ventilation support is done . Once patient fulfils the criteria for weaning will be given SBT with CPAP of 5 cm of H20 And PS of 5cm of H2O Number of incidents of weaning failure will be recorded and correlated with the Mechanical power corrected to static compliance Those who show intolerance to SBT or do not fulfil weaning protocol will be reinitiated on sedation, and reconsidered at 24 hrs interval by same methodology. |