| CTRI Number |
CTRI/2025/09/095402 [Registered on: 25/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to see how weakness in patients with COPD affects their chances of survival and the number of days they stay in ICU |
|
Scientific Title of Study
|
Impact of Frailty Score on Predicting Mortality and Length of ICU Stay in COPD patients: A Prospective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| YEC-4/2025/078 version 02 11/08/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Surendran K P |
| Designation |
Student |
| Affiliation |
Yenepoya School of Allied Health Sciences (Deemed to be University) |
| Address |
MSc in Respiratory Therapy (Student) Yenepoya School of Allied Health Sciences (Deemed to be University) Mudipu Campus, Near Surya Tech Park Kayargoli, Kurnad Post, Bantwal TQ.
Dakshina Kannada
KARNATAKA
574153
India |
| Phone |
7356100909 |
| Fax |
|
| Email |
anjalisurendrankp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kavya Shettigar K |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya School of Allied Health Sciences (Deemed to be University) |
| Address |
Guide, Department of Respiratory Therapy Yenepoya School of Allied Health Sciences (Deemed to be University) Mudipu Campus, Near Surya Tech Park Kayargoli, Kurnad Post, Bantwal TQ.
Dakshina Kannada
KARNATAKA
574153
India |
| Phone |
9741734428 |
| Fax |
|
| Email |
kavyashettigar@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nivetha N |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya School of Allied Health Sciences (Deemed to be University) |
| Address |
Co Guide, Department of Respiratory Therapy Yenepoya School of Allied Health Sciences (Deemed to be University) Mudipu Campus, Near Surya Tech Park Kayargoli, Kurnad Post, Bantwal TQ.
Dakshina Kannada
KARNATAKA
574153
India |
| Phone |
9361113568 |
| Fax |
|
| Email |
nivethan@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya School of Allied Health Sciences (Deemed to be University) Mudipu Campus, Near Surya Tech Park Kayargoli, Kurnad Post, Bantwal TQ.
|
|
|
Primary Sponsor
|
| Name |
Anjali Surendran K P |
| Address |
Yenepoya School of Allied Health Sciences (Deemed to be University) Mudipu Campus, Near Surya Tech Park Kayargoli, Kurnad Post, Bantwal TQ.
|
| 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 |
| Anjali Surendran K P |
Yenepoya Medical College Hospital |
MICU and Stepdown ICU, 2nd floor, Yenepoya Medical College Hospital, University road, Derlakatte, Mangalore, 575018
Dakshina Kannada
KARNATAKA |
7356100909
anjalisurendrankp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committe-4 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Any gender of Age 40 years to 80 years.
Confirmed diagnosis of COPD.
ICU admission for acute exacerbation of COPD.
Patients shifted to another ICU within the same hospital.
|
|
| ExclusionCriteria |
| Details |
Patients with other terminal illnesses.(Advanced or metastatic cancers,End-Stage Organ Failure, Severe Neurological Conditions with Poor Prognosis, Advanced Immunodeficiency Syndromes) Patients Shifted from the ICU within 24 hours.
Patients with incomplete medical records.
Patients shifted from the ICU to ward.
Patients readmitted to ICU from ward. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The length of the ICU stay can be assesed in relation to the frailty scoring.
|
At ICU discharge or 30 days after admission, |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Predictive accuracy of the frailty scoring can be assessed compared to APACHE II and SOFA score for ICU mortality in COPD patients. |
At ICU discharge or 30 days after admission, |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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)
|
05/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/10/2025 |
| 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
|
This is a prospective observational study to be conducted in the Medical ICU and step down ICU of Yenepoya Medical College Hospital Mangalore . The study aims to evaluate the impact of frailty on outcomes in patients with Chronic Obstructive Pulmonary Disease admitted to the ICU. Frailty will be assessed using the Clinical Frailty Scale and compared with standard severity scoring systems including APACHE II and SOFA. Adult patients with COPD admitted to the ICU during the study period will be consecutively enrolled after applying eligibility criteria. Demographic clinical and laboratory data will be obtained from medical records and patients will be followed until ICU discharge or up to 30 days. Mortality and length of ICU stay will be documented and statistical analysis will be performed to compare the predictive ability of frailty with APACHE II and SOFA scores. The study is self funded ethically approved does not involve any additional intervention beyond routine care and seeks to provide evidence to guide prognostication and resource planning for critically ill COPD patients. |