| CTRI Number |
CTRI/2025/10/095865 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of scales that assess function of patients in ICU to predict their length of stay in the ICU |
|
Scientific Title of Study
|
Comparison of commonly used ICU functional scales in predicting length of stay of patients admitted in the ICU: An observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hitanshi Waghela |
| Designation |
PG Student |
| Affiliation |
D.Y. Patil deemed to be university, School of Physiotherapy, Navi Mumbai |
| Address |
D.Y. Patil deemed To Be University, School of Physiotherapy, Department of Cardiovascular and Pulmonary Physiotherapy, 6th Floor, Plot No. 2, Sector-5, Nerul, Navi
Mumbai- 400706
D.Y. Patil deemed to be university, School of Physiotherapy, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9049588228 |
| Fax |
|
| Email |
hitanshiwaghela16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anuprita Thakur |
| Designation |
HOD and Professor |
| Affiliation |
Dept. of Cardiovascular & Pulmonary Physiotherapy, School of Physiotherapy, D.Y. Patil deemed to be University, Navi Mumbai |
| Address |
D.Y. Patil deemed To Be University, School of Physiotherapy, Department of Cardiovascular and Pulmonary Physiotherapy, 6th Floor, Plot No. 2, Sector-5, Nerul, Navi
Mumbai- 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9820132985 |
| Fax |
|
| Email |
anuprita.thakur@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Hitanshi Waghela |
| Designation |
PG Student |
| Affiliation |
D.Y. Patil deemed to be university, School of Physiotherapy, Navi Mumbai |
| Address |
D.Y. Patil deemed To Be University, School of Physiotherapy, Department of Cardiovascular and Pulmonary Physiotherapy, 6th Floor, Plot No. 2, Sector-5, Nerul, Navi
Mumbai- 400706
D.Y. Patil deemed to be university, School of Physiotherapy, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9049588228 |
| Fax |
|
| Email |
hitanshiwaghela16@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.Y. Patil deemed To Be University, School of Physiotherapy, Department of Cardiovascular and Pulmonary Physiotherapy, 6th Floor, Plot No. 2, Sector-5, Nerul, Navi
Mumbai, India - 400706 |
|
|
Primary Sponsor
|
| Name |
D.Y. Patil deemed to be university, School of Physiotherapy, Navi Mumbai |
| Address |
D.Y. Patil deemed To Be University, School of Physiotherapy, Department of Cardiovascular and Pulmonary Physiotherapy, 6th Floor, Plot No. 2, Sector-5, Nerul, Navi
Mumbai- 400706 |
| Type of Sponsor |
Private medical college |
|
|
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 Hitanshi Waghela |
D.Y. Patil deemed to be university, School of Physiotherapy, Navi Mumbai |
D.Y. Patil deemed To Be University, School of Physiotherapy, Department of Cardiovascular and Pulmonary Physiotherapy, 6th Floor, Plot No. 2, Sector-5, Nerul, Navi
Mumbai- 400706
Thane
MAHARASHTRA |
9049588228
hitanshiwaghela16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee for Biomedical and Health Research IECBH of Dr D Y Patil Medical College & Hospital Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J962||Acute and chronic respiratory failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Both gender patients with more than 18 years of age
2.Patients who have independent mobility before hospital admission
3.Patients who require ICU stay for at least 72 hours
|
|
| ExclusionCriteria |
| Details |
1.Patients who develop unaccountable cardiovascular or pulmonary complications.
2.Patients who are haemodynamic unstable.
3.Patients who have premorbid physical and cognitive impairment that will prevent physical ability
4.Patients who are admitted with any central nervous system disorder such as cerebrovascular accident, spinal cord injury, meningitis following head trauma.
5.Patients who have amputation in more than 2 limbs in which muscle strength will be tested.
6.Patients who have unstable fractures or injuries that will require bed rest.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the physical function in ICU using various scales such as PFIT, FSS-ICU, Perme ICU mobility score, ICU Mobility Scale |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare PFIT, FSS-ICU, Perme ICU mobility score, ICU Mobility Scale in predicting Length of Stay in ICU. |
4 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
20/10/2025 |
| 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="4"
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
|
Title: Comparison of commonly used ICU Functional Scales in
predicting length of stay of patients admitted in the ICU: An observational
study Need of study: Using ICU Functional scales
is important as it helps in delivering mobility interventions to provide improvements
in physical function, reduce complications and reduce length of stay in the ICU. As
there are multiple scales available to assess the functional status in ICU such
as PFIT, FSS-ICU, the Perme ICU mobility score, ICU Mobility Score, it is essential
to compare these scales and find out which scale is better to predict the
length of stay in ICU of the patient so that it can be implemented in practice. Till
date, comparison of multiple ICU functional scales in predicting the length of
stay in ICU is not done. This study will help us in determining which scale will be a better tool in predicting the length of stay in the ICU. Aims: To compare commonly used ICU Functional Scales in predicting the Length
of Stay of patients admitted in the ICU
PRIMARY OBJECTIVES: To measure the physical function in ICU using various sclaes such as PFIT, FSS-ICU, Perme ICU mobility score, ICU Mobility Scale SECONDARY OBJECTIVES: To compare PFIT, FSS-ICU, Perme ICU mobility score, ICU Mobility Scale in predicting Length of Stay in ICU. Material and Methods Study Setting - – D.Y Patil Hospital and Research Centre, Navi Mumbai. Study design – Prospective Observational Study Study duration – 6 months Study participants/subjects- Patients admitted in all adult ICUs. Sample size – 124 Sampling procedure – Convenience sampling Outcome Measures: Following scales will be used to measure the physical function in ICU 1.The Physical Function in ICU Test 2.Functional Status Score for ICU 3.Perme ICU Mobility Score 4.ICU Mobility Scale
Plan of study: 1.Participants willing to participate in the study and fulfilling the inclusion criteria will be selected. 2.Detailed procedure of the study and time required to perform the tests will be explained to the sampled population in the language best understood to them. 3.Informed consent will be taken from the study sampled population 4.Demographic data including name, age, gender, height, weight, past medical history, past surgical history, addictions, comorbidities will be recorded 5.Current details of the patient will include: Heart rate, Blood pressure, Respiratory rate, oxygen saturation, MRC-SS, ICU Diagnosis of the patient, duration of mechanical ventilation (wherever applicable), ICU length of stay, Hospital length of stay, gcs. 6.On the days D1, D3, D5, D7 of ICU stay, ICU Functional Scales - Physical function in ICU test (PFIT), Functional Status Score for the Intensive Care Unit (FSS-ICU), The Perme Intensive Care Unit Mobility Score, ICU Mobility Scale will be recorded. 7.To asses the influence of ICU functional scales on ICU length of stay, a simple linear regression analysis will be performed, where the dependent variable will be ICU length of stay and the independent variable will the scores of ICU functional scales which will be tested individually.
|