| CTRI Number |
CTRI/2025/01/079153 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of modified scoring method (IWI) to predict weaning outcomes in mechanically ventilated patients. |
|
Scientific Title of Study
|
Evaluation of modified Integrative Weaning Index to predict the weaning outcome in mechanically ventilated patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apoorva M |
| Designation |
Respiratory Therapist |
| Affiliation |
Bharati Hospital and Research center,Pune |
| Address |
Room No-225,
Department of Critical Care Medicine, Bharati Hospital and Research Center,Pune-411043,Maharashra,India.
Pune
MAHARASHTRA
411043
India |
| Phone |
7483427927 |
| Fax |
|
| Email |
apoorvam912001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Apoorva M |
| Designation |
Respiratory Therapist |
| Affiliation |
Bharati Hospital and Research center,Pune |
| Address |
Room No-225,
Department of Critical Care Medicine, Bharati Hospital and Research Center,Pune-411043,Maharashra,India.
MAHARASHTRA
411043
India |
| Phone |
7483427927 |
| Fax |
|
| Email |
apoorvam912001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Apoorva M |
| Designation |
Respiratory Therapist |
| Affiliation |
Bharati Hospital and Research center,Pune |
| Address |
Room No-225,
Department of Critical Care Medicine, Bharati Hospital and Research Center,Pune-411043,Maharashra,India.
MAHARASHTRA
411043
India |
| Phone |
7483427927 |
| Fax |
|
| Email |
apoorvam912001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Hospital and Research Center,Pune |
|
|
Primary Sponsor
|
| Name |
Bharati Hospital and Research Center,Pune |
| Address |
Room No-225,
Department of Critical Care Medicine, Bharati Hospital and Research Center,Pune-411043,Maharashra,India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kumari Sulochna |
Bharati Hospital and Research Centre |
Room No 225,Division of Respiratory Therapy, Bharati Hospital and Research Center,Pune- Satara-Road Pune-411043,Maharashra,India.
Pune
MAHARASHTRA |
9881519089
sulochana.rt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Medical College,Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J969||Respiratory failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients who are on mechanical ventilation for more than 24 hours. |
|
| ExclusionCriteria |
| Details |
1-Patient declining consent.
2-Patient with Neuromuscular disorder.
3-Patient who underwent Tracheostomy before weaning.
4-Patients with post-surgical/operative cases who have shifted to the ICU for extubation/monitoring.
5-Death without ventilator weaning.
6-Permanent ventilator dependency.
7-Cardio-pulmonary arrest on ventilator.
8-Self-extubation / Aspiration during weaning.
9-Copious secretions and mucus plugging precluding wean. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified IWI as a routine predictor of weaning failure over RSBI |
120 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="103"
Sample Size from India="103"
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)
|
31/01/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Weaning is the process of gradually withdrawing mechanical ventilatory support and transferring the work of breathing from the ventilator to the patient.A weaning index or predictive parameter for weaning is a criterion that evaluates a given physiological aspect of respiratory function, with the objective of distinguishing between patients who might tolerate the SBT and those who might not.Spontaneous Breathing Trial (SBT) is a part of weaning process which evaluates the patient spontaneous efforts without any ventilatory support.Weaning Indexes are the parameters which are use to evaluate the patient’s rediness for extubation or liberation of ventilatory support.Weaning Indexes that evaluate one single function have generally presented poor accuracy in comparison with the integrative parameters.Hence having the Integrated weaning Index or Integrative parameters that evaluate more than one physiological aspect of respiratory function may predict the SBT tolerance (weaning success) or SBT intoerance (weaning failure).One such integrative weaning index has introduced and stated as IWI = (Cst,rs × SaO2) ÷ RR/V T and concluded that IWI is the best predictive performance index of weaning outcome.However the study has limitation that calculating Static compliance during the weaning phase by taking the patient back on Volume control mode. Hence we presented the Modified Integrative Weaning Index by substitute Static compliance with Dynamic compliance and stated as Modified IWI=(Cdyn,rs × SaO2) ÷ RR/V T. |