| CTRI Number |
CTRI/2024/05/066916 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical Profile and Outcome of Pulmonary Disease in patients admitted in Respiratory Intensive Care Unit |
|
Scientific Title of Study
|
Clinical Profile and Outcome of Pulmonary Disease in patients admitted in Respiratory Intensive Care Unit- a cross sectional 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 |
Dr Kishan Prakash Rai |
| Designation |
Junior Resident M.D Respiratory Medicine |
| Affiliation |
Rohilkhand Medical College |
| Address |
DEPARTMENT OF RESPIRATORY MEDICINE,ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,PILIBHIT BYPASS ROAD,BARIELLY
Bareilly UTTAR PRADESH 243006 India |
| Phone |
9740669242 |
| Fax |
|
| Email |
kishanprai@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mohd Javed Khan |
| Designation |
Associate Professor |
| Affiliation |
Rohilkhand Medical College |
| Address |
DEPARTMENT OF RESPIRATORY MEDICINE,ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,PILBHIT BYPASS ROAD,BARIELLY
Bareilly UTTAR PRADESH 243006 India |
| Phone |
8755147786 |
| Fax |
|
| Email |
javedpulmonarymedicine@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mohd Javed Khan |
| Designation |
Associate Professor |
| Affiliation |
Rohilkhand Medical College |
| Address |
DEPARTMENT OF RESPIRATORY MEDICINE,ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,PILBHIT BYPASS ROAD,BARIELLY
Bareilly UTTAR PRADESH 243006 India |
| Phone |
8755147786 |
| Fax |
|
| Email |
javedpulmonarymedicine@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Rohilkhand Medical College and Hospital |
| Address |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,PILBHIT BYPASS ROAD,SURESH SHARMA NAGAR,BARIELLY |
| 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 Kishan Prakash Rai |
Rohilkhand Medical College and Hospital |
Room no- 1090/6, Respiratory Intensive Care Unit, Bareilly, Uttar Pradesh Bareilly UTTAR PRADESH |
9740669242
kishanprai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Rohilkand Medical College & Hospital Bareilly |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J440||Chronic obstructive pulmonary disease with acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients who fulfil the following criteria will be included:
1.Patients willing to give informed consent.
2.All the patients admitted in RICU
|
|
| ExclusionCriteria |
| Details |
The group of patients excluded from the study include those:
1.Patients not willing to participate in the study.
2.Patients of HIV positive status
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the pattern of pulmonary disease and outcome of patients admitted in RICU at tertiary care centre. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To Study the Patients clinical profile admitted in RICU.
2. To assess the outcome of patient staying in RICU with various pulmonary diseases.
3. To determine pattern of pulmonary disease commonly seen in RICU. |
one year |
|
|
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)
|
15/05/2024 |
| 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="0" 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
|
Respiratory intensive care unit is
an area within hospital which is well equipped and under control of specialised
team of doctors, nurses and paramedical staff for providing all possible health
facilities to the patient.
It is also a specialized place for
the monitoring and treatment of patients with acute respiratory failure due to
any cause and of patient with acute or chronic respiratory failure. Thus, these
patients are a heterogeneous
group with severe illnesses, with or
without multiple system dysfunction / failure and multiple coexisting medical
problems1.
It is well accepted that early and appropriate
referral of patients to an intensive care unit can significantly reduce early
and possible late mortality in critically ill patients. At the same time
improper selection of patients for intensive care unit, who block ICU beds
often limits bed availability in ICUs and may adversely affect the dynamics of
the hospital1.
The common diseases with which a
patients is admitted in RICU are:
1.
Acute
Exacerbation of COPD
2.
Pneumonia:
-
Hospital acquired pneumonia is the second most common nosocomial infection in
intensive care unit. HAP is the most common cause of mortality which ranges
from 30 to 70%. Incidence of HAP is higher in ICU acquired respiratory
infection4
3. BRONCHECTIASIS
4. PNEUMOTHORAX
5.
BRONCHIAL
ASTHMA(AE)
Critically
ill patients are responsible for 10–20% of global hospital costs and the
ability to identify critically ill patients who will not survive until hospital
discharge may allow identification of high risk patients 2
Patients inside respiratory Intensive Care
Unit A Clinician has to consider many
inter-related factors in making a prognosis regarding outcome in critically ill
patients, including age, severity and irreversibility of the acute illness,
physiological reserve, associated co morbidity and response to therapy.
This
study will be conducted to find out the clinical profile, intervention given
and final outcome of patients admitted in our respiratory icu which may help us
to form a management guideline for better treatment of patients. |